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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00929240
First received: June 16, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine)versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin.Eligible patients will receive up to 6 x 3week cycles of treatment with Avastin (15mg/mg iv on day 1 of each cycle) + docetaxel (75-100mg/m2 iv on day 1 of each cycle).Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15mg/kg iv on day 1 of each cycle)+ Xeloda (1000mg/m2 po bid on days 1-14 of each cycle) or b)Avastin alone.The anticipated time on study treatment is until disease progression, 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: 286
Study Start Date: July 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle (maintenance phase)
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)
Active Comparator: 2 Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle (maintenance phase)

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929240

  Show 63 Study Locations
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: NCT00929240     History of Changes
Other Study ID Numbers: MO22223, 2008-006872-31
Study First Received: June 16, 2009
Last Updated: November 18, 2013
Health Authority: Spain: Ministry of Health

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

ClinicalTrials.gov processed this record on July 22, 2014