A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT01120184
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1095
- Adult participants >/=18 years of age
- HER2-positive breast cancer
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
- Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Adequate organ function as determined by laboratory results
- History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
- An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
- Hormone therapy <7 days prior to randomization
- Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization
- Prior trastuzumab emtansine or pertuzumab therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trastuzumab + Taxane (docetaxel or paclitaxel) docetaxel - Trastuzumab + Taxane (docetaxel or paclitaxel) trastuzumab [Herceptin] - Trastuzumab emtansine + pertuzumab pertuzumab - Trastuzumab emtansine + pertuzumab placebo pertuzumab-placebo - Trastuzumab + Taxane (docetaxel or paclitaxel) paclitaxel - Trastuzumab emtansine + pertuzumab trastuzumab emtansine - Trastuzumab emtansine + pertuzumab placebo trastuzumab emtansine -
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) According to IRF Assessment Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.
Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Died at 2 Years From randomization until 2 years Percentage of Participants Experiencing Treatment Failure Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. The percentage of participants with treatment failure was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
Overall Survival (OS) at Clinical Cutoff Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
Percentage of Participants With Death or Disease Progression According to Investigator Assessment Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
One-Year Survival Rate From randomization until 1 year The percentage of participants alive at 1 year after randomization was estimated as the one-year survival rate using Kaplan-Meier analysis, and corresponding CIs were computed using Greenwood's estimate of the standard error.
Overall Survival Truncated at 2 Years From randomization until 2 years Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years.
PFS According to Investigator Assessment Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
Time to Treatment Failure (TTF) Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. TTF was defined as the time from randomization to treatment failure. Median TTF was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
Percentage of Participants With Grade 5 Adverse Events Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose) Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death.
Hospitalization Days Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants.
Percentage of Participants Who Died Prior to Clinical Cutoff Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) The percentage of participants who died prior to clinical cutoff was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
Percentage of Participants With Grade ≥3 Adverse Events Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. Grade 5: Death.
Percentage of Participants With Grade 3-4 Laboratory Parameters Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014 Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.
Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose) The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as \[number of participants meeting the above threshold divided by the number analyzed\] multiplied by 100.
Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months) The ECOG performance status is a scale used to quantify cancer participants' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, \< 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, \> 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death.
Percentage of Participants With Objective Response According to IRF Assessment Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate \[ORR\]) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose) The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: \[number of participants meeting the above threshold divided by the number analyzed\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
Percentage of Participants With Hospitalization Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment.
Percentage of Participants With Objective Response According to Investigator Assessment Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Objective response was defined as having CR or PR, assessed according to RECIST version 1.1, by investigator. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2 The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: \[number of participants with any level of either symptom divided by the number analyzed\] multiplied by 100.
Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score Baseline, Cycle 7 (Week 18) The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect).
Duration of Response According to IRF Assessment Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Duration of response was defined as the time from confirmed PR or CR to first documented disease progression or death from any cause. CR was defined as the disappearance of all target lesions and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. Median duration of response was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient (20%) increase to qualify for disease progression. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR, PR, or SD was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100.
Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014 The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100.
PFS According to IRF Assessment Among Those With High HER2 mRNA Levels Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) The percentage of participants who died prior to clinical cutoff was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score Baseline, Cycle 7 (Week 18) The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as \[mean score at the assessment visit minus mean score at Baseline\]. The higher the score, the higher the level of impairment or burden.
Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score Baseline, Cycle 7 (Week 18) The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)
Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100.
Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) The percentage of participants who died prior to clinical cutoff was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
OS at Clinical Cutoff Among Those With High HER2 mRNA Levels Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis.
OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination) OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. Reported upper bound of confidence interval for "Trastuzumab Emtansine + Placebo" and confidence interval values for "Trastuzumab + Taxane" and "Trastuzumab Emtansine + Pertuzumab" are censored values.
Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.
Trial Locations
- Locations (257)
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
🇹🇭Bangkok, Thailand
Gazi Uni Medical Faculty Hospital; Oncology Dept
🇹🇷Ankara, Turkey
Bristol Haematology and Oncology centre
🇬🇧Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
🇬🇧Cornwall, United Kingdom
Guys Hospital; Management Offices
🇬🇧London, United Kingdom
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
🇬🇧Glasgow, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
🇬🇧Leicester, United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
🇬🇧London, United Kingdom
Nottingham City Hospital; Oncology
🇬🇧Nottingham, United Kingdom
Christie Hospital; Breast Cancer Research Office
🇬🇧Manchester, United Kingdom
Peterborough City Hospital; Oncology Ward
🇬🇧Peterborough, United Kingdom
University of Washington
🇺🇸Seattle, Washington, United States
Fondazione Salvatore Maugeri
🇮🇹Pavia, Lombardia, Italy
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
🇰🇷Seoul, Korea, Republic of
Clnc L Trials & Rsch Assoc-Inc
🇺🇸Montebello, California, United States
Kaiser Permanente; Oncology Clinical Trials
🇺🇸Vallejo, California, United States
Northwest Oncology/ Hematology Assoc.
🇺🇸Coral Springs, Florida, United States
Innovative Medical Research of South Florida
🇺🇸Aventura, Florida, United States
Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Florida Cancer Specialists; SCRI
🇺🇸Fort Myers, Florida, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
University Cancer & Blood Center, LLC; Research
🇺🇸Athens, Georgia, United States
Uni of Chicago
🇺🇸Chicago, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Loyola University Med Center
🇺🇸Maywood, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
🇺🇸Annapolis, Maryland, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
St. John'S Mercy Medical Center; David C. Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Cancer & Hematology
🇺🇸Springfield, Missouri, United States
Queens Medical Associates
🇺🇸Fresh Meadows, New York, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Marion L. Shepard Cancer Center
🇺🇸Washington, North Carolina, United States
Carolina Oncology Specialists, PA - Hickory
🇺🇸Hickory, North Carolina, United States
Weill Medical College of Cornell Uni
🇺🇸New York, New York, United States
Sanford Roger Maris Cancer Center
🇺🇸Fargo, North Dakota, United States
Oncology Hematology Care - SCRI
🇺🇸Cincinnati, Ohio, United States
Vanderbilt-Ingram Cancer Ctr
🇺🇸Nashville, Tennessee, United States
Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
🇺🇸Houston, Texas, United States
Uni of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States
Calvary Mater Newcastle; Medical Oncology
🇦🇺Waratah, New South Wales, Australia
Royal Adelaide Hospital; Oncology
🇦🇺Adelaide, South Australia, Australia
Oncology Consultants Limited
🇧🇸Nassau, Bahamas
Clinique Ste-Elisabeth
🇧🇪Namur, Belgium
Liga Norte Riograndense Contra O Câncer
🇧🇷Natal, RN, Brazil
Clinic of Oncology, University Clinical Center Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
*X*Instituto Nacional do Cancer - INCA
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, RS, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco
🇧🇷Porto Alegre, RS, Brazil
Clinica de Neoplasias Litoral
🇧🇷Itajai, SC, Brazil
Hospital Perola Byington
🇧🇷Sao Paulo, SP, Brazil
North York General Hospital
🇨🇦Toronto, Ontario, Canada
CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
🇨🇦Quebec, Canada
Clinica del Country
🇨🇴Bogota, Colombia
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Vejle Sygehus; Onkologisk Afdeling
🇩🇰Vejle, Denmark
Fakultni nemocnice Olomouc; Onkologicka klinika
🇨🇿Olomouc, Czechia
Institut régional du Cancer Montpellier
🇫🇷Montpellier, France
HOPITAL JEAN MINJOZ; Oncologie
🇫🇷Besancon, France
Centre Jean Perrin; Hopital De Jour
🇫🇷Clermont Ferrand, France
Institut Paoli Calmettes; Oncologie Medicale
🇫🇷Marseille, France
Centre D'Oncologie de Gentilly; Oncology
🇫🇷Nancy, France
Centre Oscar Lambret; Senologie
🇫🇷Lille, France
Institut Curie; Oncologie Medicale
🇫🇷Paris, France
Centre Rene Huguenin; ONCOLOGIE GENETIQUE
🇫🇷Saint Cloud, France
HOPITAL TENON; Cancerologie Medicale
🇫🇷Paris, France
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
🇩🇪Essen, Germany
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
🇩🇪Halle, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
🇩🇪Heidelberg, Germany
Facharztzentrum Eppendorf, Studien GbR
🇩🇪Hamburg, Germany
Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe
🇩🇪Magdeburg, Germany
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Minden, Germany
Rotkreuzklinikum München; Frauenklinik
🇩🇪Muenchen, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
🇩🇪Trier, Germany
Alexandras General Hospital of Athens; Oncology Department
🇬🇷Athens, Greece
Univ General Hosp Heraklion; Medical Oncology
🇬🇷Heraklion, Greece
Grupo Angeles
🇬🇹Guatemala City, Guatemala
Centro Oncológico Sixtino / Centro Oncológico SA
🇬🇹Guatemala, Guatemala
Semmelweis Egyetem Onkologiai Központ
🇭🇺Budapest, Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
🇭🇺Pécs, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
🇭🇺Budapest, Hungary
A.O. Universitaria Policlinico Di Modena; Ematologia
🇮🇹Modena, Emilia-Romagna, Italy
Ospedale Degli Infermi; Divisione Di Oncologia
🇮🇹Rimini, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
🇮🇹Meldola, Emilia-Romagna, Italy
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
🇮🇹Catanzaro, Calabria, Italy
Arcispedale Santa Maria Nuova; Oncologia
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Centro Catanese Di Oncologia; Oncologia Medica
🇮🇹Catania, Sicilia, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
🇮🇹Perugia, Umbria, Italy
National Hospital Organization Kyushu Cancer Center;Breast Oncology
🇯🇵Fukuoka, Japan
Gifu University Hospital; Digestive Surgery
🇯🇵Gifu, Japan
Hiroshima University Hospital; Breast Surgery
🇯🇵Hiroshima, Japan
National Hospital Organization Hokkaido Cancer Center; Breast Surgery
🇯🇵Hokkaido, Japan
Hyogo Cancer Center; Breast Surgery
🇯🇵Hyogo, Japan
Kanazawa University Hospital; Breast Oncology
🇯🇵Ishikawa, Japan
Iwate Med Univ School of Med; Surgery
🇯🇵Iwate, Japan
Sagara Hospital; Breast Surgery
🇯🇵Kagoshima, Japan
Kyoto University Hospital; Breast Surgery
🇯🇵Kyoto, Japan
Kumamoto City Hospital, Breast and Endocrine Surgery
🇯🇵Kumamoto, Japan
Saitama Medical University International Medical Center; Medical Oncology
🇯🇵Saitama, Japan
Kawasaki Medical School Hospital; Breast and Thyroid Surgery
🇯🇵Okayama, Japan
Shizuoka General Hospital; Breast Surgery
🇯🇵Shizuoka, Japan
Shizuoka Cancer Center; Breast Surgery
🇯🇵Shizuoka, Japan
National Cancer Center Hospital; Medical Oncology
🇯🇵Tokyo, Japan
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
🇯🇵Tokyo, Japan
Toranomon Hospital; Breast and Endocrine Surgery
🇯🇵Tokyo, Japan
Tokyo Medical Uni. Hospital; Breast Oncology
🇯🇵Tokyo, Japan
Samsung Medical Centre; Division of Hematology/Oncology
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital; Oncology
🇰🇷Seoul, Korea, Republic of
Sunway Medical Centre
🇲🇾Selangor, Malaysia
Centro de Investigacion; Clinica Del Pacifico
🇲🇽Acapulco, Guerrero, Mexico
Centro Universitario Contra El Cancer
🇲🇽Monterrey, Nuevo LEON, Mexico
Hospital Privado San Jose; Oncologia
🇲🇽Obregon, Sonora, Mexico
Centenario Hospital Miguel Hidalgo
🇲🇽Aguascalientes, Mexico
Centro Oncológico Estatal; ISSSEMYM Oncología
🇲🇽Toluca, Mexico
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
🇵🇪Lima, Peru
Private Health Organization Acibadem Sistina Hospital
🇲🇰Skopje, North Macedonia
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
🇵🇪Arequipa, Peru
Waikato Hospital; Regional Cancer Center
🇳🇿Hamilton, New Zealand
The Panama Clinic
🇵🇦Panama, Panama
Unidad de Investigacion Oncologia Clinica ? Piura; Unidad de Oncología Clínica
🇵🇪Piura, Peru
Cebu Cancer Institute; Perpetual Succour Hospital
🇵🇭Cebu City, Philippines
Medical University of Gdansk
🇵🇱Gdansk, Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
🇵🇱Bydgoszcz, Poland
Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii
🇵🇱Krakow, Poland
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
🇵🇱Warszawa, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
🇵🇱Lublin, Poland
IPO do Porto; Servico de Oncologia Medica
🇵🇹Porto, Portugal
Coltea Hospital; Oncology
🇷🇴Bucharest, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
🇷🇴Cluj Napoca, Romania
Cluj Clinical County Hospital; Oncology Dept
🇷🇴Cluj-Napoca, Romania
Blokhin Cancer Research Center; Combined Treatment
🇷🇺Moskva, Moskovskaja Oblast, Russian Federation
Ryazan State Medical University Named after I.P.Pavlov
🇷🇺Ryazan, Rjazan, Russian Federation
Ivanovo Regional Oncology Dispensary
🇷🇺Ivanovo, Russian Federation
Hospital Univ Vall d'Hebron; Servicio de Oncologia
🇪🇸Sant Andreu de La Barca, Barcelona, Spain
Tula Regional Oncology Dispensary
🇷🇺Tula, Russian Federation
GUZ Vladimir Regional Clinical Oncological Dispensary
🇷🇺Vladimir, Russian Federation
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
🇪🇸Jaen, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
🇪🇸Santiago de Compostela, LA Coruña, Spain
Hospital del Mar; Servicio de Oncologia
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
🇪🇸Malaga, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Universitario La Paz; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
🇪🇸Valencia, Spain
Kantonsspital Baden; Medizinische Klinik, Onkologie
🇨🇭Baden, Switzerland
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
🇸🇪Malmö, Sweden
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
🇨🇭Chur, Switzerland
Universitaetsspital Basel; Onkologie
🇨🇭Basel, Switzerland
Changhua Christian Hospital; Hematology-Oncology
🇨🇳Changhua, Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
🇨🇳Kaohsiung, Taiwan
National Taiwan Uni Hospital; Dept of Oncology
🇨🇳Taipei, Taiwan
National Cancer Inst.
🇹🇭Bangkok, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
🇹🇭Bangkok, Thailand
Maharaj Nakorn Hospital; Internal Medicine
🇹🇭Chiang Mai, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
🇹🇷Adana, Turkey
Songklanagarind Hospital; Department of Oncology
🇹🇭Songkhla, Thailand
Cukurova Uni Faculty of Medicine; Medical Oncology
🇹🇷Adana, Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept
🇹🇷Izmir, Turkey
Royal Free Hospital; Dept of Oncology
🇬🇧London, United Kingdom
Queen Alexandra Hospital, Portsmouth
🇬🇧Portsmouth, United Kingdom
Southampton General Hospital; Somers Cancer Research Building
🇬🇧Southampton, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
🇬🇧Sheffield, United Kingdom
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
🇬🇧Stoke-on-Trent, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
🇬🇧Sutton, United Kingdom
University of Minnesota.
🇺🇸Minneapolis, Minnesota, United States
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
🇳🇿Auckland, New Zealand
Scripps Cancer Center
🇺🇸La Jolla, California, United States
University of California; Moores Cancer Center
🇺🇸La Jolla, California, United States
Breastlink Medical Group Inc
🇺🇸Santa Ana, California, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Spectrum Health Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Carolinas Hem-Oncology Assoc
🇺🇸Charlotte, North Carolina, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie
🇨🇿Praha, Czechia
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, RS, Brazil
Southern California Kaiser Permanente
🇺🇸San Diego, California, United States
Horizon Oncology Research, Inc.
🇺🇸Lafayette, Indiana, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Arena Oncology Associates
🇺🇸Lake Success, New York, United States
The Don & Sybil Harrington Cancer Center; Department of Clinical Research
🇺🇸Amarillo, Texas, United States
The Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Mater Misericordiae Hospital; Chemotherapy Cottage
🇦🇺Sydney, New South Wales, Australia
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, SP, Brazil
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
🇨🇿Praha 2, Czechia
Chu La Miletrie; Radiotherapie
🇫🇷Poitiers, France
Hopital Saint Louis; Service Onco Thoracique
🇫🇷Paris, France
Institut de Cancerologie de La Loire; Radiotherapie
🇫🇷St Priest En Jarez, France
MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)
🇩🇪Hannover, Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
🇩🇪Mainz, Germany
University Hospital of Larissa; Oncology
🇬🇷Larissa, Greece
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Ospedale Papardo- Piemonte;Oncologia Medica
🇮🇹Messina, Sicilia, Italy
IRCCS Istituto Clinico Humanitas; Oncologia
🇮🇹Rozzano (MI), Lombardia, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
🇮🇹Prato, Toscana, Italy
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
🇯🇵Ehime, Japan
Niigata Cancer Ctr Hospital; Breast Surgery
🇯🇵Niigata, Japan
Seoul National University Bundang Hospital; Hematology Medical Oncology
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
🇰🇷Seoul, Korea, Republic of
Moscow city oncology hospital; #62 of Moscow Healthcare Department
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
🇷🇺Kazan, Tatarstan, Russian Federation
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
🇷🇺Pyatigorsk, Stavropol, Russian Federation
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
🇷🇺Samara, Russian Federation
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
🇷🇺Stavropol, Russian Federation
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
🇪🇸La Coruña, Spain
Hospital General Universitario de Elche; Servicio de Oncologia
🇪🇸Elche, Alicante, Spain
Rajavithi Hospital; Division of Medical Oncology
🇹🇭Bangkok, Thailand
Centro Medico San Roque
🇦🇷San Miguel de Tucuman, Argentina
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
🇦🇹Salzburg, Austria
Sint Augustinus Wilrijk
🇧🇪Wilrijk, Belgium
Dartmouth Hitchcock Med Center
🇺🇸Lebanon, New Hampshire, United States
South Carolina Oncology Associates - SCRI
🇺🇸Columbia, South Carolina, United States
University Clinical Centre of the Republic of Srpska
🇧🇦Banja Luka, Bosnia and Herzegovina
National Hospital Organization Osaka National Hospital; Breast Surgery
🇯🇵Osaka, Japan
Saitama Cancer Center, Breast Oncology
🇯🇵Saitama, Japan
Cardinal Santos Medical Center
🇵🇭San Juan, Philippines
Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center
🇺🇸Little Rock, Arkansas, United States
Fundación Investigar
🇦🇷Buenos Aires, Argentina
Tohoku University Hospital; General Surgery
🇯🇵Miyagi, Japan
Oaxaca Site Management Organization
🇲🇽Oaxaca de Juárez, Oaxaca, Mexico
Mountain States Tumor Inst.
🇺🇸Boise, Idaho, United States
SCRI Tennessee Oncology Chattanooga
🇺🇸Chattanooga, Tennessee, United States
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
Osaka University Hospital; Breast and Endocrine Surgery
🇯🇵Osaka, Japan
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Cancer Inst. of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Cuse - Centre Universitaire De Sante; Site Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
🇦🇹Wien, Austria
Cliniques Universitaires St-Luc
🇧🇪Bruxelles, Belgium
Centro Medico Imbanaco
🇨🇴Cali, Colombia
Instituto Cancerologico de Nariño
🇨🇴Pasto, Colombia
Tennessee Onc., PLLC - SCRI
🇺🇸Nashville, Tennessee, United States
Aichi Cancer Center Hospital, Breast Oncology
🇯🇵Aichi, Japan
Hyogo College Of Medicine; Breast And Endocrine Surgery
🇯🇵Hyogo, Japan
Hackensack Uni Medical Center; Northern Nj Cancer Center
🇺🇸Hackensack, New Jersey, United States
Cross Cancer Institute; Clinical Trials
🇨🇦Edmonton, Alberta, Canada
Peter Maccallum Cancer Institute; Medical Oncology
🇦🇺Melbourne, Victoria, Australia
West Clinic
🇺🇸Germantown, Tennessee, United States
Szent Margit Hospital; Dept. of Oncology
🇭🇺Budapest, Hungary
Tri-Service General Hospital; Hematology and Oncology
🇨🇳Taipei, Taiwan
Beacon International Specialist Centre
🇲🇾Petaling Jaya, Selangor, Selangor, Malaysia
Instituto Colombiano Para El Avance De La Medicina: Icamedic
🇨🇴Bucaramanga, Colombia
Tokai University Hospital, Breast Surgery
🇯🇵Kanagawa, Japan
Kumamoto University Hospital; Breast and Endocrine Surgery
🇯🇵Kumamoto, Japan
Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy
🇲🇾Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia
Smilow Cancer Hospital at Yale New Haven
🇺🇸New Haven, Connecticut, United States
Cancer Research Center of Hawaii; Clinical Sciences
🇺🇸Honolulu, Hawaii, United States
James Graham Brown Cancer Center, University of Louisville
🇺🇸Louisville, Kentucky, United States
Charleston Oncology, P .A
🇺🇸Charleston, South Carolina, United States
Medical University of SC (MUSC)
🇺🇸Charleston, South Carolina, United States
Mayo Clinic-Jacksonville
🇺🇸Jacksonville, Florida, United States
Queens Hospital Center
🇺🇸Jamaica, New York, United States
Wesley Medical Centre; Clinic For Haematology and Oncology
🇦🇺Auchenflower, Queensland, Australia
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