Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

Recruiting in Palo Alto (17 mi)

+18 other locations

Overseen byAmelia Zelnak, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Research Team

Amelia Zelnak, MD

Principal Investigator

Emory University Winship Cancer Institute

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed breast carcinoma.

Early stage breast cancer (stage 1, 2, 3).

No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.

See 2 more

Treatment Details

Interventions

Capecitabine (Anti-metabolites)
Docetaxel (Taxane)

Participant Groups

2Treatment groups

Active Control

Group I: Sequential TherapyActive Control2 Interventions

Docetaxel will be given at 100mg/m\^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).

Group II: Concurrent TherapyActive Control2 Interventions

Docetaxel will be given at 50mg/m\^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Capecitabine is already approved in Canada, Japan for the following indications: