A Study of Avastin (Bevacizumab) in Combination With Taxane-Based Chemotherapy as First Line Treatment in Patients With HER2 Negative Breast Cancer.
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00846027
First received: February 17, 2009
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
This single arm study will assess the efficacy and safety of first line treatment with Avastin in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER2 negative breast cancer. Eligible patients will receive Avastin 10mg/kg iv, paclitaxel 150mg/m2 and gemcitabine 200mg/m2 iv on days 1 and 15 of each 4 week treatment cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: bevacizumab [Avastin] Drug: paclitaxel Drug: gemcitabine |
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 FIRST LINE TREATMENT WITH AVASTIN IN COMBINATION WITH PACLITAXEL AND GEMCITABINE IN PROGRESSION-FREE SURVIVAL IN PATIENTS WITH HER-2 NEGATIVE BREAST CANCER |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Event driven; tumor assessments every 3 cycles ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Best overall survival; overall response; duration of response; [ Time Frame: Event driven; tumor assessments every 3 cycles ] [ Designated as safety issue: No ]
- Adverse events; laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]
| Enrollment: | 89 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
10mg/kg iv on days 1 and 15 of each 4 week cycle
Drug: paclitaxel
150mg/m2 iv on days 1 and 15 of each 4 week cycle
Drug: gemcitabine
200mg/m2 iv on days 1 and 15 of each 4 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;
- breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only;
- HER2-negative disease;
- candidates for chemotherapy;
- ECOG PS of <=2;
Exclusion Criteria:
- previous chemotherapy for metastatic or locally advanced breast cancer;
- previous radiotherapy for treatment of metastatic breast cancer;
- any prior adjuvant treatment with anthracyclines completed <6 months prior to enrolment;
- chronic daily treatment with corticosteroids (>=10mg/day) aspirin (>325mg/day) or clopidogrel (>75mg/day);
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846027
Locations
| Spain | |
| Alcorcon, Spain, 28922 | |
| Barcelona, Spain, 08907 | |
| Barcelona, Spain, 08022 | |
| Burgos, Spain, 09005 | |
| Cádiz, Spain, 11009 | |
| Córdoba, Spain, 14004 | |
| Elda, Spain, 03600 | |
| Granada, Spain, 18003 | |
| Granada, Spain, 18014 | |
| Huelva, Spain, 21005 | |
| Jaen, Spain, 23007 | |
| Las Palmas de Gran Canaria, Spain, 35016 | |
| Lugo, Spain, 27004 | |
| Madrid, Spain, 28222 | |
| Madrid, Spain, 28041 | |
| Manresa, Spain, 08243 | |
| Marbella, Spain, 29600 | |
| Murcia, Spain, 30008 | |
| Sagunto, Spain, 46520 | |
| Sevilla, Spain, 41009 | |
| Sevilla, Spain, 41014 | |
| Vigo, Spain, 36214 | |
| Zaragoza, Spain, 50009 | |
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: | NCT00846027 History of Changes |
| Other Study ID Numbers: | ML21999, 2008-003657-32 |
| Study First Received: | February 17, 2009 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Spain:Agencia Espanola del Medicamento |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Bevacizumab Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents |
Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2012
