NCT00148720

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

September 7, 2005

Last Update Submit

November 9, 2015

Conditions

Invasive Breast CarcinomaPrimary Invasive Breast CancerStage I Breast CancerStage II Breast CancerStage III Breast Cancer

Keywords

Invasive Breast CancerOperable Breast CancerCapecitabine

Outcome Measures

Primary Outcomes (1)

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

    3 years

Interventions

CapecitabineDRUG

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

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

    PMID: 24464780RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Ian Krop, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2007

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

US(3)