A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
18 Years
N/A
Female
Invasive Breast Carcinoma, Primary Invasive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
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
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.
Type of Study:
Interventional
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:
No
Principal Investigator
Ian Krop, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
04-167
NCT ID:
NCT00148720
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
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Faulkner Hospital | Jamaica Plain, Massachusetts 02130 |
