P. Palacios-Ozores (Santiago de Compostela, Spain)
CHUS - Complejo Hospitalario Universitario de Santiago de Compostela SERGASAuthor Of 1 Presentation
- E. Ciruelos (Madrid, Spain)
- F. Salvador Bofill (Sevilla, Spain)
- A. Perello Martorell (Palma de Mallorca, Spain)
- E. Alba Conejo (Málaga, Spain)
- X. González-Farré (Sant Cugat del Vallés, Spain)
- P. Palacios-Ozores (Santiago de Compostela, Spain)
- M. Merino (Madrid, Spain)
- P. Villagrasa (Barcelona, Spain)
- E. Vila Navarro (Barcelona, Spain)
- T. Pascual (Barcelona, Spain)
- A. Prat (Barcelona, Spain)
- S. Pernas Simon (Hospitalet de Llobregat, Spain)
73TiP - SOLTI1710 PROMETEO II: Palbociclib in combination with letrozole in Hormone Receptor-positive (HR+)/HER2-negative residual disease after standard neoadjuvant chemotherapy (NAC)
Abstract
Background
The combination of cyclin-dependent kinase inhibitors (CDK4/6i) with first or second-line endocrine therapy are the standard of care for HR+/HER2-negative metastatic breast cancer (BC); its role in the early-setting is being evaluated in several studies with discordant results. In HR+/HER2-negative BC, pathologic complete response (pCR) rates after NAC are around 15%. Additional therapeutic strategies to eradicate these residual tumor cells are needed. To characterize the biological effect of CDK4/6i in residual disease (RD) after NAC, could help to better understand their role in early BC.
Trial design
SOLTI-1710 PROMETEO II is an open-label, multicenter window of opportunity trial of Palbociclib and letrozole tested in patients with HR+/HER-negative RD after completing anthracycline/taxane-based NAC. PROMETEO II will include 22 patients. Invasive RD must be confirmed by core-biopsy and have a diameter ≥ 10mm measured by ultrasound. Adequate organ function and ECOG PS 0-1 are required. A short course of Palbociclib is administered at a dose of 125 mg/day for 21 days and letrozole 2.5 mg/day continuously until surgery. BC surgery is carried out 1 week after the last dose of palbociclib. The primary objective of the trial is to evaluate the antitumor activity by the Complete Cell Cycle Arrest (CCCA) rate determined by Ki67 ≤2.7%, centrally assessed at surgery. Secondary endpoints include pCR rate, RCB and safety. To date, 12 patients have been included at 8 sites in Spain.
Clinical trial identification
NCT04130152.
Legal entity responsible for the study
SOLTI.
Funding
Pfizer.
Disclosure
E. Ciruelos: Advisory/Consultancy, Non-remunerated activity/ies: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy: Lilly; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Novartis; Advisory/Consultancy: MSD. X. González-Farré: Advisory/Consultancy: SOLTI Breast Cancer Group; Advisory/Consultancy, Non-remunerated activity/ies: Roche; Advisory/Consultancy: Eisai. P. Villagrasa: Honoraria (self): NanoString. A. Prat: Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Novartis; Honoraria (self), Advisory/Consultancy: MSD Oncology; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo; Research grant/Funding (self): NanoString Technologies; Advisory/Consultancy: Oncolytics Biotech; Advisory/Consultancy: Amgen; Advisory/Consultancy: PUMA. S. Pernas Simon: Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Polyphor; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Roche. All other authors have declared no conflicts of interest.