The investigators propose in the present study an innovative approach, combining the most recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response evaluation method. In line with the most recent recommendations on targeted anticancer therapies, the investigators have designed a parallel phase II randomized trial with early stopping rules 26, which will able in the meantime to build a unique prospective collection of tumor tissue, pre- and post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Institut Curie
Paris, France
Gustave Roussy
Villejuif, France
Evaluation of the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.
Time frame: 21 weeks
Evaluation of the clinical response in each treatment arm as defined by clinical and ultrasound examination.
Time frame: 21 weeks
Determination of the number and type of Adverse Events as a Measure of Safety and Tolerability
The toxicity will be evaluated according to the scale CTC-AE version 4.0
Time frame: 21 weeks
Correlation of the PAM50 risk of recurrence (ROR) score to its ability to predict RCB as defined in outcome 1
Time frame: 21 weeks
Calculation of the rates of breast conservation therapy in the two arms with regard to the initially planned surgery.
Time frame: 21 weeks
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