Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Pemetrexed

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.

• Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).

• Adequate organ function (bone marrow, hepatic, renal, cardiac).

Exclusion Criteria:

• Prior anthracyclines as part of prior anticancer therapy.

• Concurrent antitumor therapy.

• Second primary malignancy.

• Serious concomitant systemic disorder.

• Pre-existing sensorial or motor neuropathy

• Grade 1.