A Study of Avastin (Bevacizumab) in Combination With Gemcitabine and Carboplatin as First Line Treatment in Patients With Triple Negative Metastatic Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: September 6, 2010
Last updated: April 2, 2016
Last verified: April 2016
This multicenter study will assess the efficacy and safety of Avastin (bevacizumab) in combination with gemcitabine and cisplatin as first line treatment in patients with triple negative metastatic breast cancer. Patients will receive Avastin at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an AUC=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: carboplatin
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (PFS), according to RECIST criteria, assessments by CT/MRI/bone scans and X-ray [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate (ORR), according to RECIST criteria, assessed by CT/MRI/bone scan and Xray [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Clinical benefit response (CBR) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety and tolerability: Adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Quality of Life: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Hemodynamic measurements: brachial blood pressure, heart rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: bevacizumab [Avastin]
15 mg/kg iv every 3 weeks
Drug: carboplatin
to an AUC = 2, on days 1 and 8 of each 3-week cycle
Drug: gemcitabine
1000 mg/m2 iv on days 1 and 8 of each 3-week cycle


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients, >/= 18 years of age
  • Metastatic breast cancer
  • Estrogen receptor- , progesterone- and HER2-negative disease
  • Treatment-naïve for metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Prior first line treatment for metastatic breast cancer
  • CNS metastasis
  • Uncontrolled hypertension (> 170/95 mmHg)
  • Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
  • History of other malignant disease within past 3 years, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
  • Prior therapy with gemcitabine or carboplatin in the metastatic setting. Patients 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01201265

Ahmedabad, India, 380009
Bangalore, India, 560029
Bangalore, India, 560054
Delhi, India, 110029
Gandhinagar, India, 382428
Mahim (West), India, 400016
Mumbai, India, 400020
Mumbai, India, 400012
New Delhi, India, 110076
New Delhi, India, 110085
Pune, India, 411004
Vellore, India, 632004
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01201265     History of Changes
Other Study ID Numbers: ML25420 
Study First Received: September 6, 2010
Last Updated: April 2, 2016
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2016