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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 is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01201265
First received: September 6, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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: gemcitabine
Drug: carboplatin
 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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: gemcitabine
1000 mg/m2 iv on days 1 and 8 of each 3-week cycle
Drug: carboplatin
to an AUC = 2, on days 1 and 8 of each 3-week cycle

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201265

Contacts
Contact: Please reference Study ID Number: ML25420 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
India
Recruiting
Ahmedabad, India, 380009
Recruiting
Bangalore, India, 560054
Recruiting
Bangalore, India, 560029
Recruiting
Delhi, India, 110029
Recruiting
Gandhinagar, India, 382428
Recruiting
Mahim (west), India, 400016
Recruiting
Mumbai, India, 400012
Recruiting
Mumbai, India, 400020
Recruiting
New Delhi, India, 110085
Recruiting
Pune, India, 411004
Recruiting
Vellore, India, 632 004
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: May 7, 2013
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013