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Capecitabine in Women With Operable Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hoffmann-La Roche
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148720
First received: September 7, 2005
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  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
Invasive Breast Carcinoma
Primary Invasive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
 Drug: Capecitabine
 Phase 2

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:

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: July 2013
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine
    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 E. Krop, MD, PhD, Assistant Professor of Medicine, 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: December 14, 2012
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
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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 May 16, 2013