A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

Breast Cancer Clinical Trial

Official title:

An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448591
• Other study ID #: MO19391
• Status: Completed
• Phase: Phase 3
• First received: March 16, 2007
• Last updated: May 21, 2015
• Start date: September 2006
• Est. completion date: February 2013

Study information

• Verified date: May 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Joint Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2296
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients, >=18 years of age;

• HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;

• candidates for chemotherapy.

Exclusion Criteria:

• previous chemotherapy for metastatic or locally recurrent breast cancer;

• concomitant hormonal therapy for metastatic or locally recurrent disease;

• concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;

• previous radiotherapy for treatment of metastatic disease;

• evidence of CNS metastases.

Study Design

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]
10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle
• Taxane-based chemotherapy
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Czech Republic,  Ecuador,  Egypt,  Estonia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Latvia,  Lebanon,  Lithuania,  Mexico,  Morocco,  Netherlands,  Poland,  Portugal,  Russian Federation,  Saudi Arabia,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)	Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.	Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion	Yes
Secondary	Percentage of Participants With Disease Progression	Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.	Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months	No
Secondary	Time to Progression (TTP)	TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.	Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months	No
Secondary	Percentage of Participants With Recorded Death		Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months	No
Secondary	Overall Survival	Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.	Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months	No
Secondary	Percentage of Participants by Best Overall Response to Treatment	Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.	Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months	No