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Capecitabine in Women With Operable Breast Cancer

Primary Purpose

Invasive Breast Carcinoma, Primary Invasive Breast Cancer, Stage I Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Breast Carcinoma focused on measuring Invasive Breast Cancer, Operable Breast Cancer, Capecitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Faulkner Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
November 9, 2015
Sponsor
Dana-Farber Cancer Institute
Collaborators
Hoffmann-La Roche, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00148720
Brief Title
Capecitabine in Women With Operable Breast Cancer
Official Title
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Hoffmann-La Roche, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Breast Carcinoma, Primary Invasive Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Keywords
Invasive Breast Cancer, Operable Breast Cancer, Capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles
Primary Outcome Measure Information:
Title
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Krop, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Faulkner Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24464780
Citation
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.
Results Reference
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Learn more about this trial

Capecitabine in Women With Operable Breast Cancer

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