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Low Dose Chemotherapy With Aspirin in Patients With Breast Cancer After Neoadjuvant Chemotherapy

NCT01612247 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-06-05

No results posted yet for this study

Summary

Patients with stage II-III breast cancer who do not achieve a pathologic complete response to neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less, against an alternative hypothesis (HA) event rate of 25% or more.

Conditions

Interventions

DRUG

Cyclophosphamide and Methotrexate and Aspirin

Cyclophosphamide 50 mg PO daily x 28 days, cycles 1-4 Methotrexate 2.5 mg PO twice daily, days 1 and 2 each week x 4 weeks, cycles 1-4 ASA: 325 mg PO daily x 28 days, cycles 3 and 4 Treatment will be given for a total of 4 cycles.

Sponsors & Collaborators

  • Maimonides Medical Center

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • University of Vermont

    lead OTHER

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612247 on ClinicalTrials.gov