Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments standard treatment, selective treatment
Phase phase 2
Sponsor Spanish Breast Cancer Research Group
Collaborator Pfizer
Start date September 2007
End date July 2013
Trial size 189 participants
Trial identifier NCT00432172, GEICAM/2006-03

Summary

This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype) and a random assignment will be performed to standard or experimental treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Standard treatment
standard treatment
EC x 4 -> Tx4
(Experimental)
Selective treatment
selective treatment
Postmenopausic patients: exemestane x 6 months; Premenopausic Patients: goserelin x 6 months + exemestane x 6 months
(Active Comparator)
Standard treatment
standard treatment
ECx4-> Tx4
(Experimental)
selective treatment
EC x4->CBPT x4

Primary Outcomes

Measure
Response rate
time frame: After surgey.

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: - Written informed consent. - Breast cancer with histological diagnosis. - Negative HER2neu tumours(defined as IHQ 0,1+). - No evidence of suspicion of metastatic disease. - Age >= 18 years old. - Performance status (Karnofsky index) >= 80 (ECOG 0,1). - Adequate cardiac function by ECG in the previous 12 weeks. - Hematology: neutrophils >= 1,5 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl. - Adequate hepatic function: total bilirubin <= 1x upper normal limit (UNL); SGOT and SGPT <= 2.5xUNL; alkaline phosphatase <= 2.5xUNL. - Adequate renal function: creatinine <= 1xUNL; creatinine clearance >= 60 ml/min. - Patients able to comply with study treatment and follow-up. - Negative pregnancy test in the previous 14 days. Exclusion Criteria: - HER2neu positive tumours (defined as IHQ 3+ or positive FISH). - Prior systemic therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy). - Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy. - Prior radiotherapy for breast cancer. - Bilateral invasive breast cancer. - Pregnant or lactating women. - Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC]). - Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen. - Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma. - Chronic treatment with corticosteroids. - Contraindications for administration of corticosteroids. - Concomitant treatment with other therapy for cancer. - Males.

Additional Information

Official title "A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients"
Description Group 1 (Luminal A): - Standard treatment: EC x 4 -> Tx4 - Selective treatment: Postmenopausic patients: exemestane x 6 months; Premenopausic Patients: goserelin x 6 months + exemestane x 6 months Group 2 (Basal): - Standard treatment: EC x 4 -> Tx4 - Selective treatment: EC x 4 -> CDPT x 4
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Spanish Breast Cancer Research Group.