Capecitabine in Women With Operable Breast Cancer

Phase 2

Terminated

• Conditions: Invasive Breast Carcinoma; Primary Invasive Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Stage I Breast Cancer

• Registration Number: NCT00148720
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2007-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.	3 years

Trial Locations

Locations (3)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States