Capecitabine in Women With Operable 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. Identifier: NCT00148720
Recruitment Status : Terminated (Slow accrual)
First Posted : September 8, 2005
Last Update Posted : November 11, 2015
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

Brief Summary:
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 or disease Intervention/treatment Phase
Invasive Breast Carcinoma Primary Invasive Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Drug: Capecitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
Study Start Date : September 2004
Actual Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Capecitabine
    Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles

Primary Outcome Measures :
  1. To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer. [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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): NCT00148720

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Hoffmann-La Roche
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Principal Investigator: Ian Krop, MD, PhD Dana-Farber Cancer Institute

Publications of Results:
Responsible Party: Ian E. Krop, MD, PhD, Assistant Professor of Medicine, Dana-Farber Cancer Institute Identifier: NCT00148720     History of Changes
Other Study ID Numbers: 04-167
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015

Keywords provided by Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute:
Invasive Breast Cancer
Operable Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents