Capecitabine in Women With Operable Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Invasive Breast Carcinoma Primary Invasive Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Capecitabine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No