LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT01271725
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 74
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vinorelbine 25 mg/m2 weekly Vinorelbine 25 mg/m2 weekly Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy Afatinib 40mg once daily (OD) Afatinib 40mg once daily (OD) Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease Paclitaxel 80 mg/m2 weekly Paclitaxel 80 mg/m2 weekly Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
- Primary Outcome Measures
Name Time Method Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1 From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.
- Secondary Outcome Measures
Name Time Method Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP) Baseline and End of treatment period, up to 1562 days Change from baseline to end of treatment in diastolic blood pressure (DBP).
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation) From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Progression Free Survival (PFS) From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'. Median is calculated from the Kaplan-Meier curve.
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP) Baseline and End of treatment period, up to 1562 days Change from baseline to end of treatment in systolic blood pressure (SBP).
Best Overall Response According to RECIST v1.1 (With Confirmation) From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates). Acronyms Used: Prothrombin time-International normalized ratio (PT-INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT)
Duration of Objective Response According to RECIST v1.1 From the first objective response to the time of progression or death, up to 1562 days Duration of objective response, defined as the time from first objective response to the time of progression or death. (regardless of confirmation). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher.
Trial Locations
- Locations (27)
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong
Sujan Surgical Cancer Hospital
🇮🇳Amravati, India
Tata Memorial Hospital
🇮🇳Maharashtra, India
Curie Manavata Cancer Centre
🇮🇳Maharashtra, India
Central India Cancer Research Institute
🇮🇳Nagpur, India
Ruby Hall Clinic
🇮🇳Pune, India
Regional Cancer Center
🇮🇳Thiruvananthapuram, India
University Clinical Center, Gdansk
🇵🇱Gdansk, Poland
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
🇷🇺Kazan, Russian Federation
Scroll for more (17 remaining)Queen Mary Hospital🇭🇰Hong Kong, Hong Kong