A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT01201265|
Recruitment Status : Completed
First Posted : September 14, 2010
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Bevacizumab Drug: Carboplatin Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Overall Participants
Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.
15 mg/kg iv every 3 weeks
Other Name: AvastinDrug: Carboplatin
to an AUC = 2, on days 1 and 8 of each 3-week cycleDrug: Gemcitabine
1000 mg/m2 iv on days 1 and 8 of each 3-week cycle
- Progression-free Survival (PFS) [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days). ]Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
- Percentage of Participants Achieving an Overall Response [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days) ]The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters.
- Percentage of Participants Achieving a Clinical Benefit Response (CBR) [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days) ]Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- Time to Progression (TTP) [ Time Frame: From the date of registration until the disease progression (up to 1541 days). ]Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression.
- Overall Survival (OS) [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days) ]Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method.
- Number of Participants With an Adverse Event (AE) [ Time Frame: Up to 28 days after termination of study treatment (approximately 1569 days) ]An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) [ Time Frame: Baseline, cycle 6 ]The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms.
- Change From Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Cycle 6, 12 of treatment ]Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD).
- Change From Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Cycle 6, 12 of treatment ]Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201265
|Ahmedabad, India, 380009|
|Bangalore, India, 560029|
|Bangalore, India, 560054|
|Delhi, India, 110029|
|Gandhinagar, India, 382428|
|Mumbai, India, 400012|
|Mumbai, India, 400016|
|Mumbai, India, 400020|
|New Delhi, India, 110011|
|New Delhi, India, 110085|
|Pune, India, 411004|
|Vellore, India, 632004|
|Study Director:||Clinical Trials||Hoffmann-La Roche|