A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: June 16, 2009
Last updated: October 13, 2014
Last verified: October 2014

This randomized study will compare maintenance therapy with Avastin (bevacizumab ) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative m etastatic breast cancer who have not progressed during first-line therapy with d ocetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of tr eatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg

/m2 IV on Day 1 of each cycle). Those patients who do not progress will be rando mized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle)

  • Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. St udy treatment will continue until disease progression, unacceptable toxicity, pa tient request for withdrawal or end of study, and the target sample size is 100- 500 individuals.

Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: assessed every 9 weeks (after every 3rd cycle) until progression ] [ Designated as safety issue: No ]

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

Enrollment: 285
Study Start Date: July 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Avastin (bevacizumab) Drug: bevacizumab [Avastin]
15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
Experimental: Avastin (bevacizumab) + Xeloda (capecitabine) Drug: bevacizumab [Avastin]
15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
Drug: capecitabine [Xeloda]
1000 mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)


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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • HER2-negative metastatic breast cancer
  • candidates for taxane-based chemotherapy;
  • ECOG performance status of 0 or 1.

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00929240

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00929240     History of Changes
Other Study ID Numbers: MO22223, 2008-006872-31
Study First Received: June 16, 2009
Last Updated: October 13, 2014
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 19, 2014