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TerminatedNCT00148720Updated Nov 11, 2015

Capecitabine in Women With Operable Breast Cancer

A Phase 2 interventional study of Capecitabine in Invasive Breast Carcinoma, Primary Invasive Breast Cancer and Stage I Breast Cancer, sponsored by Dana-Farber Cancer Institute. Terminated at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-11.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment

Why this study was terminated
Slow accrual
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
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Conditions studied

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

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Keywords

  • Invasive Breast Cancer
  • Operable Breast Cancer
  • Capecitabine
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

  • DrugCapecitabine

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

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What researchers measure

Primary outcomes

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

    Time frame: 3 years

07

Study locations

3 sites
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02115, United States
  • Faulkner Hospital
    Boston, Massachusetts 02130, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
08

References and documents

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. PubMed 24464780 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00148720
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Hoffmann-La Roche, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
Responsible party
Ian E. Krop, MD, PhD (Assistant Professor of Medicine, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 8, 2005
Start date
Sep 2004
Primary completion
Sep 2007
Last update
Nov 11, 2015

Study contacts

Ian Krop, MD, PhD
principal investigator · Dana-Farber Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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