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A Study of Avastin With Taxane Therapy in Patients With Triple Negative Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01094184
First received: March 16, 2010
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

This open-label, multi-centre study will evaluate the safety, tolerability and e ffect 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) brea st cancer. Patients are eligible to participate in this study if they have not r eceived 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 bevacizum ab (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 i s < 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:


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 ]

Enrollment: 49
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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
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: NCT01094184

Locations
United Kingdom
Bangor, United Kingdom, LL57 2PD
Cottingham, United Kingdom, HU16 5JG
Exeter, United Kingdom, EX2 5DW
Grimsby, United Kingdom, DN33 2BA
Harrogate, United Kingdom, HG2 8AY
Plymouth, United Kingdom, PL6 8DH
Portsmouth, United Kingdom, PO6 3LY
Preston, United Kingdom, PR2 9HT
Somerset, United Kingdom, TA1 5DA
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: November 10, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014