Capecitabine in Women With Operable Breast Cancer

Dana-Farber Cancer Institute

Status and phase

Terminated

Phase 2

Conditions

Invasive Breast Carcinoma

Stage II Breast Cancer

Stage I Breast Cancer

Stage III Breast Cancer

Primary Invasive Breast Cancer

Treatments

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00148720

04-167

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.