NCT00036621

Brief Summary

This clinical trial will assess whether BMS-275291 can be administered safely in combination with standard adjuvant therapy for early breast cancer and whether plasma concentrations at trough exceed a target minimum.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

9 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Last Updated

March 2, 2010

Status Verified

August 1, 2007

First QC Date

May 11, 2002

Last Update Submit

February 27, 2010

Conditions

Breast Cancer

Interventions

BMS-275291DRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed pathologic stage 1c-IIIA adenocarcinoma of the breast which has been completely resected.
  • Systemic therapy is planned according to one of the following three regimens:
  • Tamoxifen (20mg) given orally once per day
  • Adriamycin (60 mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery)
  • Adriamycin (60mg/m2 IV on Day 1) plus cyclophosphamide (600mg/m2 IV on Day 1), repeated every 21 days for four courses, followed by Taxol (175mg/m2 IV on Day 85) repeated every 21 days for four courses (to begin within 8 weeks after definitive surgery).
  • ECOG performance status 0 or 1.
  • Adequate organ function as evidenced by:
  • ANC \> 1500/mm3
  • Platelets \> 100,000/mm3
  • Serum Creatine \< 1.5 ULN
  • Total bilirubin \< 1.5 x ULN
  • AST \< 2 x ULN
  • Patients to receive adriamycin must have LVEF \> 50% or acceptable function per the institutional practice as assessed by MUGA.
  • Signed informed consent.
  • Women age =/\> 18 years
  • +2 more criteria

You may not qualify if:

  • Patients in whom breast cancer is present at the margin or surgical resection are not eligible in this study. Patients suspicious for residual disease following resection are not eligible.
  • Prior chemotherapy or immunotherapy for breast cancer.
  • Documented metastatic breast cancer.
  • Other malignancy (except carcinoma in situ of the cervix or surgically treated non-melanoma skin cancer) within 5 years of study entry.
  • Pregnant or breastfeeding females.
  • Women of child bearing potential not employing adequate contraception.
  • History of autoimmune diseases such as systemic lupus, rheumatoid arthritis, scleroderma.
  • Any serious underlying medical conditions which would impair the ability ot the patient to receive the planned treatment or which may interfere with the completion of this trial.
  • Planned chemotherapy, hormonal therapy or biological therapy other than those described above. Patients should not be enrolled in any other clinical trials. Use of other investigational agents is not permitted.
  • Any condition that does not permit compliance with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Local Institution

Chicago, Illinois, United States

Location

Local Institution

Indianapolis, Indiana, United States

Location

Local Institution

Baltimore, Maryland, United States

Location

Local Institution

The Bronx, New York, United States

Location

Local Institution

Cincinnati, Ohio, United States

Location

Local Institution

Portland, Oregon, United States

Location

Local Institution

Burlington, Vermont, United States

Location

Local Institution

Vancouver, Washington, United States

Location

Local Institution

Green Bay, Wisconsin, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

N-((2S)-2-mercapto-1-oxo-4-(3,4,4- trimethyl-2,5-dioxo-1-imidazolidinyl)butyl)-L-leucyl-N,3- dimethyl-L-Valinamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 11, 2002

First Posted

May 13, 2002

Primary Completion

September 1, 2002

Last Updated

March 2, 2010

Record last verified: 2007-08

Locations

US(9)