Capecitabine in Women With Operable Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hoffmann-La Roche
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148720
First received: September 7, 2005
Last updated: April 30, 2014
Last verified: April 2014

September 7, 2005
April 30, 2014
September 2004
September 2007   (final data collection date for primary outcome measure)
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.
Complete list of historical versions of study NCT00148720 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Capecitabine in Women With Operable Breast Cancer
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer

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.

  • 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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Invasive Breast Carcinoma
  • Primary Invasive Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
Drug: Capecitabine
Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
July 2014
September 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148720
04-167
Not Provided
Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Hoffmann-La Roche
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
Principal Investigator: Ian Krop, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP