A clinical trial to study the effects of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during initial docetaxel plus bevacizumab therapy

A randomised Phase III clinical study of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000423

Enrollment

360

Registered

2009-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Metastatic breast cancer

Interventions

Intervention1: Bevacizumab: 15mg/kg iv on day 1 of each 3 week cycle (maintenance phase) Intervention2: capecitabine: 1000mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase) Control I

Eligibility

Inclusion criteria

Inclusion criteria: -adult patients, greater or equal to18 years of age; -HER2-negative metastatic breast cancer -candidates for taxane-based chemotherapy; -ECOG performance status of 0 or 1.

Exclusion criteria

Exclusion criteria: -previous chemotherapy for metastatic breast cancer; -prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study; -prior radiotherapy for treatment of metastatic disease; chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).

Design outcomes

Primary

Measure	Time frame
Progression-free survivalTimepoint: [ Time Frame: assessed every 9 weeks (after every 3rd cycle) until progression ] [ Designated as safety issue: No ]	—

Secondary

Measure	Time frame
Adverse events; laboratory parametersTimepoint: [ Time Frame: every 3 weeks at treatment visit throughout study ] [ Designated as safety issue: No ] ;Overall response; clinical benefit rate; time to tumor progression; overall survivalTimepoint: [ Time Frame: from assessments every 9 weeks (after every 3rd cycle); overall survival monitored for at least 24 months ] [ Designated as safety issue: No ]	—

Measure

Time frame

Adverse events; laboratory parametersTimepoint: [ Time Frame: every 3 weeks at treatment visit throughout study ] [ Designated as safety issue: No ] ;Overall response; clinical benefit rate; time to tumor progression; overall survivalTimepoint: [ Time Frame: from assessments every 9 weeks (after every 3rd cycle); overall survival monitored for at least 24 months ] [ Designated as safety issue: No ]

—

Countries

Brazil, China, Egypt, France, Hong Kong, India, Italy, Poland, Spain, Turkey

Contacts

Public ContactDr Aditi Parekh

Roche Products (India) Pvt. Ltd.

binay.swarup@roche.com022-24941414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026