Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
- Conditions
- Metastatic Breast Cancer (MBC)
- Interventions
- Registration Number
- NCT00236899
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 241
- Histologic diagnosis of metastatic breast cancer (MBC).
- Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
- Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
- Patients with measurable disease.
- Previous hormonal therapy for adjuvant setting or metastatic disease.
- Previous chemotherapy for MBC
- Previous chemotherapy with gemcitabine in any setting of disease
- Patient candidable to treatment with trastuzumab.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A: Docetaxel and Gemcitabine (Tri-weekly) Docetaxel Docetaxel and Gemcitabine (Tri-weekly) A: Docetaxel and Gemcitabine (Tri-weekly) Gemcitabine Docetaxel and Gemcitabine (Tri-weekly) B: Paclitaxel and Gemcitabine (Tri-weekly) Gemcitabine Paclitaxel and Gemcitabine (Tri-weekly) C: Docetaxel and Gemcitabine (Weekly) Gemcitabine Docetaxel and Gemcitabine (Weekly) C: Docetaxel and Gemcitabine (Weekly) Docetaxel Docetaxel and Gemcitabine (Weekly) B: Paclitaxel and Gemcitabine (Tri-weekly) Paclitaxel Paclitaxel and Gemcitabine (Tri-weekly) D: Paclitaxel and Gemcitabine (Weekly) Gemcitabine Paclitaxel and Gemcitabine (Weekly) D: Paclitaxel and Gemcitabine (Weekly) Paclitaxel Paclitaxel and Gemcitabine (Weekly)
- Primary Outcome Measures
Name Time Method Time to Progressive Disease (TTPD) by Treatment Schedule Baseline up to 49.84 months TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Time to Progressive Disease (TTPD) by Treatment Drug Baseline up to 49.84 months TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) by Treatment Schedule Baseline up to 51.64 months OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Overall Survival (OS) by Treatment Drug Baseline up to 51.64 months OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Overall Response Rate (ORR) by Treatment Schedule Baseline up to 49.84 months Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Overall Response Rate(ORR) by Treatment Drug Baseline up to 49.84 months Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Number of Participants With Serious and Nonserious Adverse Events (AEs) Baseline up to 51.64 months Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle Baseline up to 51.64 months RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit Baseline up to 51.64 months RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇮🇹Viterbo, Italy