COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

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. Identifier: NCT00225056
Recruitment Status : Terminated (Terminated due to lack of accrual)
First Posted : September 23, 2005
Last Update Posted : April 20, 2007
Information provided by:
Oncology Specialties, Alabama

Brief Summary:
In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: docetaxel and capecitabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Study Start Date : October 2003
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Overall clinical benefit rate

Secondary Outcome Measures :
  1. safety and tolerability
  2. evaluate QOL
  3. determine progression free survival
  4. determine time to response and overall survival

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female

Inclusion Criteria:

  • must have metastatic breast cancer
  • must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
  • must have measurable or evaluable disease
  • ECOG of 0-1
  • patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
  • must have adequate organ function
  • must be at least 19 years of age
  • peripheral neuropathy less than or equal to grade 1
  • must have voluntarily signed informed consent
  • patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled

Exclusion Criteria:

  • patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
  • patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
  • known uncontrolled existing coagulopathy
  • patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
  • use of other investigational agents in the last 28 days
  • pregnant or lactating women
  • patients who are known HIV positive
  • patients with life expectancy of less than 3 months
  • sexually active patients unwilling to practice reliable contraception during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00225056

Layout table for location information
United States, Alabama
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Sponsors and Collaborators
Oncology Specialties, Alabama
Layout table for investigator information
Principal Investigator: John M Waples, MD Oncology Specialties, PC

Additional Information:
Layout table for additonal information Identifier: NCT00225056    
Other Study ID Numbers: CCIBRE02
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic