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

NCT01201265 | Completed Phase 2 Results

• 1 other identifier: ML25420
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 12

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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.

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

Secondary Outcomes (8)

• Percentage of Participants Achieving an Overall Response

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

• Percentage of Participants Achieving a Clinical Benefit Response (CBR)

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

• Time to Progression (TTP)

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

• Overall Survival (OS)

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

• Number of Participants With an Adverse Event (AE)

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

Study Arms (1)

Overall Participants

EXPERIMENTAL

Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.

Drug: Bevacizumab; Drug: Carboplatin; Drug: Gemcitabine

Interventions

Bevacizumab DRUG

15 mg/kg iv every 3 weeks

Also known as: Avastin

Overall Participants

Carboplatin DRUG

to an AUC = 2, on days 1 and 8 of each 3-week cycle

Overall Participants

Gemcitabine DRUG

1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Overall Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Unknown Facility

Ahmedabad, 380009, India

Location

Unknown Facility

Bangalore, 560029, India

Location

Unknown Facility

Bangalore, 560054, India

Location

Unknown Facility

Delhi, 110029, India

Location

Unknown Facility

Gandhinagar, 382428, India

Location

Unknown Facility

Mumbai, 400012, India

Location

Unknown Facility

Mumbai, 400016, India

Location

Unknown Facility

Mumbai, 400020, India

Location

Unknown Facility

New Delhi, 110011, India

Location

Unknown Facility

New Delhi, 110085, India

Location

Unknown Facility

Pune, 411004, India

Location

Unknown Facility

Vellore, 632004, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 14, 2010
• Study Start: February 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 27, 2016
• Results First Posted: May 27, 2016

Record last verified: 2016-04

Locations

IN (12)