Capecitabine in Women With Operable Breast Cancer - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Hoffmann-La Roche Beth Israel Deaconess Medical Center Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00148720

Purpose

The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.

Condition	Intervention	Phase
Breast Cancer Invasive Nos Primary Invasive Breast Cancer Stage I Breast Cancer Breast Cancer Stage II Breast Cancer Stage III	Drug: Capecitabine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2009
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles

Detailed Description:

Prior to the start of treatment, patients will have a small metal clip inserted into the tumor bed to identify the tumor site to the surgeon. At that time, a needle biopsy of the breast tumor or a sentinel (underarm) lymph node biopsy will also be performed.
Patients will take capecitabine orally twice daily for 14 days. This treatment will repeat every 21 days (1 cycle). Patients will receive 4 cycles of this treatment.
A physical exam and blood work will be done every three weeks after starting therapy to monitor side effects.
After two weeks of capecitabine a biopsy from the tumor will be done to generate information about the characteristics of the tumor that may respond to capecitabine.
After completing 4 cycles (12 weeks) of capecitabine, patients will then undergo surgery to remove any remaining breast cancer (lumpectomy or mastectomy). Post-surgical treatment (radiation, chemotherapy, and hormonal therapy) is at the discretion of the patients physician.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological confirmation of primary invasive breast cancer
Stage I-III operable breast cancer.
Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
Women greater than 18 years of age
ECOG performance status 0-1
WBC > 4000/mm3
Platelet count > 100,000/mm3
SGOT < 2x ULN
Calculated creatinine clearance > 50ml/min

Exclusion Criteria:

Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study.
Pregnant or breast-feeding women
Inflammatory breast cancer
HER2 positive disease
History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency
Uncontrolled intercurrent illness
Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
Excisional biopsy performed prior to enrollment
Uncontrolled coagulopathy
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148720

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Faulkner Hospital
Boston, Massachusetts, United States, 02130

Sponsors and Collaborators

Dana-Farber Cancer Institute

Hoffmann-La Roche

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator:

Ian Krop, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Ian Krop, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00148720 History of Changes
Other Study ID Numbers:	04-167
Study First Received:	September 7, 2005
Last Updated:	February 26, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Invasive Breast Cancer
Operable Breast Cancer
Capecitabine

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012