A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576901
First received: December 18, 2007
Last updated: March 25, 2010
Last verified: March 2010
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Purpose
This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: bevacizumab [Avastin] Drug: Docetaxel Drug: Xeloda |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | "An Open Label Study to Assess the Effect of Neoadjuvant Treatment With Docetaxel + Xeloda + Avastin on Pathological Response Rate in Inflammatory or Locally Advanced Breast Cancer" |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Pathological response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical response rate, breast-conservative surgery rate, disease-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Completion Date: | November 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
Drug: Docetaxel
75mg/m2 iv on day 1 of each 3 week cycle
Drug: Xeloda
2000mg/m2 po on days 1-15 of each 3 week cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- female patients, >=18 years of age;
- HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
- ECOG performance status 0-1.
Exclusion Criteria:
- metastatic disease (stage IV);
- previous treatment for breast cancer;
- evidence of CNS metastasis;
- current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
- clinically significant cardiovascular disease.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00576901 History of Changes |
| Other Study ID Numbers: | ML20561 |
| Study First Received: | December 18, 2007 |
| Last Updated: | March 25, 2010 |
| Health Authority: | Spain: Agencia Espanola del Medicamento |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel Capecitabine Bevacizumab Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013