Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer

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).

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.