A Study of Avastin With Taxane Therapy in Patients With Triple Negative Breast Cancer
This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01094184
First received: March 16, 2010
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This open-label, multi-centre study will evaluate the safety, tolerability and effect on disease progression, survival time and Karnofsky performance status of bevacizumab (Avastin) in combination with taxane monotherapy in female patients with oestrogen-, progesterone- and HER2-receptor negative (triple-negative) breast cancer. Patients are eligible to participate in this study if they have not received prior chemotherapy for metastatic breast cancer and in the investigator's opinion, require combination therapy for treatment of their disease. Patients will receive taxane (weekly paclitaxel or three-weekly docetaxel) and bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks as intravenously infusion). The treatment will continue until disease progression. The target sample size is < 100 patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: bevacizumab [Avastin] |
Phase 4 |
| 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: | Open-label Study of Bevacizumab (Avastin) and Taxane Monotherapy for the First-line Treatment of Patients With Advanced Triple Negative Breast Cancer. |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Bevacizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Safety, Tolerability: AEs, quality of life questionnaires [ Time Frame: AEs: Throughout study until 6 months after final dose of bevacizumab; quality of life questionnaires: every 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy: time to disease progression, duration of survival, change in Karnofsky performance status [ Time Frame: At the completion of cycles 1, 2, 3, 4 and subsequent cycles ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
10 mg/kg every 2 weeks, or 15 mg/kg every 3 weeks intravenously infusion according to chosen chemotherapy schedule
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients >/=18 years of age
- Histologically confirmed triple-negative (oestrogen and progesterone receptor (ER/PgR) and HER2 receptor negative) adenocarcinoma of the breast with metastatic disease
- Patient who in the Investigator's opinion requires combination therapy for their disease
- Life expectancy >/=12 weeks
Exclusion Criteria:
- Previous chemotherapy for metastatic breast cancer (adjuvant chemotherapy is allowed)
- Patients currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
- Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094184
Contacts
| Contact: Reference Study ID Number: ML22780 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| United Kingdom | |
| Recruiting | |
| Bangor, United Kingdom, LL57 2PD | |
| Recruiting | |
| Cottingham, United Kingdom, HU16 5JG | |
| Recruiting | |
| Exeter, United Kingdom, EX2 5DW | |
| Recruiting | |
| Grimsby, United Kingdom, DN33 2BA | |
| Recruiting | |
| Harrogate, United Kingdom, HG2 8AY | |
| Recruiting | |
| Plymouth, United Kingdom, PL6 8DH | |
| Completed | |
| Portsmouth, United Kingdom, PO6 3LY | |
| Recruiting | |
| Preston, United Kingdom, PR2 9HT | |
| Recruiting | |
| Somerset, United Kingdom, TA1 5DA | |
| Recruiting | |
| Wolverhampton, United Kingdom, WV10 0QP | |
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: | NCT01094184 History of Changes |
| Other Study ID Numbers: | ML22780, 2009-014279-37 |
| Study First Received: | March 16, 2010 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bevacizumab Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013