Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Eli Lilly and Company257 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

257

Conditions

Breast Cancer

Interventions

pemetrexedDRUG

500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

cyclophosphamideDRUG

600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)

doxorubicinDRUG

60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (11)

Outcomes

Primary Outcomes

Number of Participants With a Pathological Complete Response

pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy

Time frame: surgery after eight 21-day cycles of chemotherapy

Secondary Outcomes

Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy

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.

Time frame: Cycles 1-4 (21-day cycles)

Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy

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.

Time frame: Cycles 5-8 (21-day cycles)

Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery

Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.

Time frame: surgery after eight 21-day cycles of chemotherapy

Disease-free Survival

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.

Data from ClinicalTrials.gov

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Baden-Baden, Germany

Berlin, Germany

Hamburg, Germany

Heidelberg, Germany

Cremona, Italy

Rozzano, Italy

Moscow, Russia

Saint Petersburg, Russia

Jaén, Spain

Sabadell, Spain

...and 1 more locations