ER (+), HER2 (-) breast cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10028997 Term: Neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: amcenestrant
Product Code: SAR439859
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: amcenestrant
Current Sponsor code: SAR439859
Concentration unit: mg milligram(s)
Concent
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment -Confirmed diagnosis of ER+/HER2- breast cancer -No prior systemic treatment for loco-regional recurrent or metastatic disease -Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease -Eastern Cooperative Oncology Group (ECOG) performance status 0-2 -Participants should be willing to provide tumor tissue -Capable of giving informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 533
Exclusion criteria
Exclusion criteria: -Known active brain metastases -Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD) -Inadequate organ and marrow function -Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy -Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods -Male participants who disagree to follow contraception -Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term -Participants with significant concomitant illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.;Secondary Objective: -To compare the overall survival in both treatment arms -To evaluate the objective response rate in both treatment arms -To evaluate the duration of response in both treatment arms -To evaluate the clinical benefit rate in both treatment arms -To evaluate progression-free survival on next line of therapy -To evaluate the pharmacokinetics of amcenestrant, and palbociclib -To evaluate health-related quality of life in both treatment arms -To evaluate the time to first chemotherapy in both treatment arms -To evaluate safety in both treatment arms;Primary end point(s): Progression-free survival. Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever come first.;Timepoint(s) of evaluation of this end point: From randomization date to date of first documentation of progression OR death (up to approximately 4 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall Survival. Overall survival is defined as the time interval from the date of randomization to the date of documented death (due to any cause). 2. Objective Response Rate. Objective response rate is defined as the proportion of participants who have a CR or PR, as best overall response determined as per RECIST 1.1, from the date of randomization to the date of until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first. 3. Duration of Response. Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined as per RECIST 1.1 or death from any cause, whichever occurs first. 4. Clinical Benefit Rate. Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR, or SD for at least 24 weeks determined as per RECIST 1.1, from the date of randomization until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first. 5. PK parameter: Plasma concentrations. Plasma concentrations of Amcenestrant and palbociclib. 6. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). Incidence of participants with TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE V5. 7. Time to First Chemotherapy. Time to chemotherapy is defined as the time interval from the date of randomization to the start date of the first chemotherapy after study treatment discontinuation. 8. Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L). Change From Baseline between treatment comparison Using the European Quality of Life- 5-Dimension 5 Level (EQ-5D 5L). 9. Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of lif | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Czech Republic, Estonia, Finland, France, Georgia, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactTeam manager
Genzyme Europe BV
Outcome results
None listed