The purpose of this study is to evaluate the activity of molecular response in endocrine sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus Ietrozole.
The purpose of this study is: * to evaluate the rate of pathologic complete response (pCR), as defined as complete disappearance of invasive tumor in breast and axillary nodes. * to estimate the percentage of clinical objective responses (cOR) (complete plus partial) in the breast, as assessed by ultrasonography (US) * to estimate the percentage of breast conservative surgery * to evaluate the safety profile * To perform correlative biomarker analyses
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
* Pertuzumab 840 mg loading dose iv on day one, followed by 420 mg iv every 3 weeks for 5 cycles * Trastuzumab 8 mg/kg loading dose iv on day 2, followed by 6 mg/kg iv on day 2 of each subsequent 3 weekly cycle * Letrozole 2.5 mg daily p.o. for five 21-day cycles (to be continued until surgery).
Policlinico Vittorio Emanuele
Catania, CT, Italy
Arcispedale S. Anna
Cona, FE, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
Istituto Nazionale Tumori
Milan, MI, Italy
Rate of pathologic complete response
A pathologic complete response (pCR) is defined the complete absence of infiltrating tumor cells in the breast and in lymph nodes. Residual in situ disease (DCIS) will be included in the pCR category.
Time frame: At time of surgery, within 3 weeks from the last i.v. therapy
Percentage of clinical objective response.
The Clinical Response will be defined according to RECIST criteria comparing the tumor size (largest tumor diameter) before and after treatment, as assessed by ultrasound examination.
Time frame: At time of surgery, within 3 weeks from the last i.v. therapy
Rate of Conservative Surgery
Time frame: At time of surgery, within 3 weeks from the last i.v. therapy
Safety profile assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) To version 4.0 will be used
Time frame: Every 21-day cycles
Occurrence of mutations in the PIK3CA gene
Time frame: Within 4 weeks prior to first dose treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ospedale "Guglielmo da Saliceto"
Piacenza, PC, Italy
Istituto Oncologico Veneto, Oncologia Medica 2
Padova, PD, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, RE, Italy
A. O. U. Santa Maria della Misericordia
Udine, UD, Italy