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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201265
• Other study ID #: ML25420
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2010
• Last updated: April 2, 2016
• Start date: February 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
15 mg/kg iv every 3 weeks
• carboplatin
to an AUC = 2, on days 1 and 8 of each 3-week cycle
• gemcitabine
1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS), according to RECIST criteria, assessments by CT/MRI/bone scans and X-ray		approximately 3 years	No
Secondary	Overall Response Rate (ORR), according to RECIST criteria, assessed by CT/MRI/bone scan and Xray		approximately 3 years	No
Secondary	Clinical benefit response (CBR)		approximately 3 years	No
Secondary	Time to Progression (TTP)		approximately 3 years	No
Secondary	Overall Survival (OS)		approximately 3 years	No
Secondary	Safety and tolerability: Adverse events		approximately 3 years	No
Secondary	Quality of Life: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30)		approximately 3 years	No
Secondary	Hemodynamic measurements: brachial blood pressure, heart rate		approximately 3 years	No