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)
Conditions
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adult participants with histologically confirmed diagnosis of adenocarcinoma of the breast with documentation of hormone receptor-positive status, irrespective of human epidermal growth factor 2 (HER2) status NOTE: Participants with HER2-positive breast cancer are eligible only if they have completed their adjuvant anti-HER2 treatment and chemotherapy. -With Stage IIB or Stage III, early invasive breast cancer at diagnosis who have undergone breast surgery for the current malignancy. -Who have received prior aromatase inhibitors (AIs) (letrozole, anastrozole or exemestane or any sequence thereof) for at least 6 months and discontinued within 30 months from the initiation of the first AI administration due to AI treatment-related toxicity -Absence of advanced/metastatic disease -Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 -Capable of giving signed 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 3970 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 700
Exclusion criteria
Exclusion criteria: -Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant and/or tamoxifen. Participants unable to swallow normally and to take tablet and capsules. Predictable poor compliance to oral treatment. Active inflammatory bowel disease or chronic diarrhea, active hepatitis A/B/C, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures -Prior breast cancer for which they received an AI -Any other solid tumor or lymphoma diagnosis is not allowed except if the participant has been free from disease for =5 years -Pregnant or nursing women, or women of child-bearing potential without a negative pregnancy test prior to randomization -Participants with unrecovered acute toxic effects of prior AI therapy or surgical procedures -Uncontrolled intercurrent illness, including psychiatric conditions that would limit compliance with study requirements -Treatment with any another SERD, tamoxifen or toremifene are not allowed as prior adjuvant therapy but could have been used as neoadjuvant therapy for a total duration of 3 months. Participants who were treated with a SERD, tamoxifen or toremifene in the neoadjuvant setting and who experienced disease progression are not allowed - Participant is receiving concurrent HER2 directed therapy. Appropriate wash out between the last dose of HER2 directed therapy and randomization should be at least 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether amcenestrant once a day (QD) improves the invasive breast cancer-free survival (IBCFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment;Secondary Objective: •To determine whether amcenestrant once a day (QD) improves the invasive disease-free survival (IDFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment •To evaluate the distant recurrence-free survival (DRFS) in both treatment arms •To evaluate the locoregional recurrences-free survival (LRRFS) in both treatment arms •To evaluate the overall survival (OS) in both treatment arms •To evaluate the breast cancer-specific survival (BCSS) in both treatment arms •To evaluate patient-reported overall treatment-related side effect bother, treatment-related symptoms, and quality of life in both treatment arms •To evaluate safety in both treatment arms •To characterize the pharmacokinetics (PK) of amcenestrant ;Primary end point(s): 1) Invasive breast cancer-free survival (IBCFS) ;Timepoint(s) of evaluation of this end point: 1) From randomization up to approximately 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Invasive disease-free survival (IDFS) 2)Distant recurrence-free survival (DRFS) 3)Locoregional recurrences-free survival (LRRFS) 4)Overall survival (OS) 5)Breast cancer-specific survival (BCSS) 6)Patient-reported overall treatment-related side effect bother as measured by the Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5) 7)Patient-reported treatment-related symptoms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Breast cancer module (EORTC QLQ-B23) systemic therapy side effects scale 8)Patient-reported quality of life as measured by the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) global health status/quality of life (GHQ) scale 9)Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) 10)PK parameter: Plasma concentration of Amcenestrant;Timepoint(s) of evaluation of this end point: 1/2/3/4/5)From randomization up to approximately 10 years 6)From baseline up to 2 years after the end of treatment (up to approximately 7 years) 7)From baseline up to 2 years after the end of treatment (up to approximately 7 years) 8)From baseline up to 2 years after the end of treatment (up to approximately 7 years) 9)Up to 30 days after the end of treatment, approximately 5 years 10)Pre-administration day 1 of cycles 2, 7, 13 and 25 (each cycle is 28 days) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Estonia, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Portugal, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactCristina Garcia
Sanofi Produtos Farmacêuticos, Lda
Outcome results
None listed