A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

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.

Time frame: From the date of registration until the disease progression or death (up to 1541 days).

Population: Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment

Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD).

Time frame: Baseline, Cycle 6, 12 of treatment

Population: Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.

Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD).

Time frame: Baseline, Cycle 6, 12 of treatment

Population: Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.

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.

Time frame: Baseline, cycle 6

Population: Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. Here, n signifies the number of participants evaluable at specified time points.

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.

Time frame: Up to 28 days after termination of study treatment (approximately 1569 days)

Population: Safety population included all participants who received at least one dose of study treatment.

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.

Time frame: From the date of registration until the disease progression or death (up to 1541 days)

Population: Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.

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 frame: From the date of registration until the disease progression or death (up to 1541 days)

Population: Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.

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.

Time frame: From the date of registration until the disease progression or death (up to 1541 days)

Population: Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.

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.

Time frame: From the date of registration until the disease progression (up to 1541 days).

Population: Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.