Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00028990 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 15, 2023
|
Tracking Information | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | January 4, 2002 | |||||||||||||||
First Posted Date ICMJE | January 27, 2003 | |||||||||||||||
Last Update Posted Date | June 15, 2023 | |||||||||||||||
Actual Study Start Date ICMJE | January 29, 2002 | |||||||||||||||
Actual Primary Completion Date | November 2006 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
Progression-Free Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ] | |||||||||||||||
Original Primary Outcome Measures ICMJE | Not Provided | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer | |||||||||||||||
Official Title ICMJE | A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer | |||||||||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer. PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer. |
|||||||||||||||
Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease-free interval (no more than 24 months vs more than 24 months), number of metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy (yes vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline and on day 1 of weeks 17 and 33. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued for this study within 31 months. |
|||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||||||||||||||
Condition ICMJE | Breast Cancer | |||||||||||||||
Intervention ICMJE |
|
|||||||||||||||
Study Arms ICMJE |
|
|||||||||||||||
Publications * |
|
|||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||||||||
Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
722 | |||||||||||||||
Original Enrollment ICMJE | Not Provided | |||||||||||||||
Actual Study Completion Date ICMJE | May 2009 | |||||||||||||||
Actual Primary Completion Date | November 2006 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
|||||||||||||||
Sex/Gender ICMJE |
|
|||||||||||||||
Ages ICMJE | 18 Years to 120 Years (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | Canada, United States | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00028990 | |||||||||||||||
Other Study ID Numbers ICMJE | CDR0000069156 E2100 NCCTG-E2100 CAN-NCIC-MAC3 NSABP-E2100 |
|||||||||||||||
Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Current Responsible Party | Eastern Cooperative Oncology Group | |||||||||||||||
Original Responsible Party | Not Provided | |||||||||||||||
Current Study Sponsor ICMJE | Eastern Cooperative Oncology Group | |||||||||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||||||||
Collaborators ICMJE |
|
|||||||||||||||
Investigators ICMJE |
|
|||||||||||||||
PRS Account | Eastern Cooperative Oncology Group | |||||||||||||||
Verification Date | June 2023 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |