Capecitabine in Women With Operable Breast Cancer

Stage II Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00148720
• Other study ID #: 04-167
• Status: Terminated
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: November 9, 2015
• Start date: September 2004

Study information

• Verified date: November 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Med. 2014 Apr;3(2):293-9. doi: 10.100 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.		3 years	No