Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00149214
- Lead Sponsor
- Eli Lilly and Company
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 257
- 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).
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel doxorubicin - A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel pemetrexed - A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel docetaxel - A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel doxorubicin - B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel cyclophosphamide - B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel docetaxel -
- Primary Outcome Measures
Name Time Method Number of Participants With a Pathological Complete Response surgery after eight 21-day cycles of chemotherapy pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
- Secondary Outcome Measures
Name Time Method Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy Cycles 1-4 (21-day cycles) 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 Cycles 5-8 (21-day cycles) 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 surgery after eight 21-day cycles of chemotherapy Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.
Disease-free Survival baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization) 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.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇪🇸Valencia, Spain