Tamoxifen and Aspirin with AC-T Chemotherapy for Breast Cancer (Breast 51 Trial)

Phase 2

Waitlist Available

Led By Patrick Dillon, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of surgery, following completion of ac-t chemotherapy, usually about 7.5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to see if it's more effective than just AC-T chemotherapy for high-risk ER+/HER2- breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of surgery, following completion of ac-t chemotherapy, usually about 7.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of surgery, following completion of ac-t chemotherapy, usually about 7.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of surgery, following completion of ac-t chemotherapy, usually about 7.5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events (AEs)

Pathologic complete response (pCR) rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tamoxifen and Aspirin with AC-T ChemotherapyExperimental Treatment5 Interventions

AC-T chemotherapy includes 4 cycles of doxorubicin and cyclophosphamide given every 2 or 3 weeks followed by either 12 weekly cycles of lower dose paclitaxel or 4 cycles of higher dose paclitaxel every 2 or 3 weeks. During this time, all participants would receive daily aspirin and daily tamoxifen. After the AC-T chemotherapy, participants will undergo standard of care surgery to remove any remaining tumor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin

2014

Completed Phase 4

~55580

Doxorubicin

2012

Completed Phase 3

~8030