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A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Invasive Breast Carcinoma, Primary Invasive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

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Trial Information

A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer

- 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.

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

- 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)

- 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

- Excisional biopsy performed prior to enrollment

- Uncontrolled coagulopathy

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ian Krop, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2004

Completion Date:

July 2013

Related Keywords:

  • Invasive Breast Carcinoma
  • Primary Invasive Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Invasive Breast Cancer
  • Operable Breast Cancer
  • Capecitabine
  • Breast Neoplasms
  • Carcinoma



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Faulkner Hospital Jamaica Plain, Massachusetts  02130