This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery. The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Pathological complete response (pCR) rate
pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.
Time frame: Up to week 15
Overall response rate (ORR)
Tumor response is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.
Time frame: Up to week 12
Conservative surgery rate
To determine the percentage of conservative surgery rate versus other surgery
Time frame: Up to week 15
The Number of Participants Who Experienced Adverse Events (AE)
According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
Time frame: Through study treatment up to surgery
Disease-free survival
Time from the start of treatment to the progression of the disease (if it happens)
Time frame: Up to 5 years since surgery
Tissue molecular markers and their correlation with response
Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment.
Time frame: Up to week 15
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Hospital Infanta Cristina
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Hospital Universitario La Princesa
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Hospital Universitario Ramón y Cajal
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Hospital General Universitario de Valencia
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Hospital Universitario Miguel Servet
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