Capecitabine in Stage I Breast Cancer and Stage II Breast Cancer and Invasive Breast Carcinoma - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: Capecitabine

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer. Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Beth Israel Deaconess Medical Center

Hoffmann-La Roche

Brigham and Women's Hospital

Investigators

Principal Investigator: Ian Krop, MD, PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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: 10.1002/cam4.164. Epub 2014 Jan 27.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria