Clinical trial NCT01201265: A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.


Eligibility criteria: Inclusion Criteria:

* Female participants, \>/= 18 years of age
* Metastatic breast cancer
* Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease
* Treatment-naïve for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate hematological, renal and liver function
* Patients should have received Anthracyclines and Taxanes in the adjuvant setting
* Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products

Exclusion Criteria:

* Prior first line treatment for metastatic breast cancer
* Central nervous system (CNS) metastasis
* Uncontrolled hypertension (\> 170/95 mmHg)
* Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented \>6 months after the last exposure to the drug(s)
* Requirement of chronic use of immunosuppressive agents
* HIV, hepatitis B or hepatitis C infection

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From the date of registration until the disease progression or death (up to 1541 days).
Secondary outcomes:
measure: Percentage of Participants Achieving an Overall Response
timeFrame: From the date of registration until the disease progression or death (up to 1541 days)
measure: Percentage of Participants Achieving a Clinical Benefit Response (CBR)
timeFrame: From the date of registration until the disease progression or death (up to 1541 days)
measure: Time to Progression (TTP)
timeFrame: From the date of registration until the disease progression (up to 1541 days).
measure: Overall Survival (OS)
timeFrame: From the date of registration until the disease progression or death (up to 1541 days)
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to 28 days after termination of study treatment (approximately 1569 days)
measure: Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)
timeFrame: Baseline, cycle 6
measure: Change From Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Cycle 6, 12 of treatment
measure: Change From Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Cycle 6, 12 of treatment
Other outcomes:
Locations:
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Bangalore
country: India
city: Delhi
country: India
city: Gandhinagar
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Vellore
country: India
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: