Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: docetaxel; Drug: pemetrexed; Drug: cyclophosphamide; Drug: doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00149214

7113

H3E-MC-S080 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 257 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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257 participants in 2 patient groups

A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel

Experimental group

Treatment:

Drug: doxorubicin

Drug: docetaxel

Drug: pemetrexed

B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel

Active Comparator group

Treatment:

Drug: doxorubicin

Drug: cyclophosphamide

Drug: docetaxel