Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

• Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy [ Time Frame: Cycles 1-4 (21-day cycles) ] [ Designated as safety issue: No ]
  The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.
• Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy [ Time Frame: Cycles 5-8 (21-day cycles) ] [ Designated as safety issue: No ]
  The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.
• Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery [ Time Frame: surgery after eight 21-day cycles of chemotherapy ] [ Designated as safety issue: No ]
  Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.
• Disease-free Survival [ Time Frame: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization) ] [ Designated as safety issue: No ]
  Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.

• Clinical response rates
• Rate of histologically negative axillary lymph node status
• Disease-free survival
• Quantitative and qualitative toxicities

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).

• Drug: pemetrexed
  500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
  Other Name: LY231514, Alimta
• Drug: cyclophosphamide
  600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)
• Drug: doxorubicin
  60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)
• Drug: docetaxel
  100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)

• Experimental: A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
  Interventions:

  • Drug: pemetrexed
  • Drug: doxorubicin
  • Drug: docetaxel
• Active Comparator: B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
  Interventions:

  • Drug: cyclophosphamide
  • Drug: doxorubicin
  • Drug: docetaxel

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.