Breast cancer
Conditions
Interventions
Drug: Amcenestrant (SAR439859)
Pharmaceutical form: Tablet, Route of administration: Oral
Drug: Amcenestrant-matching placebo
Pharmaceutical form: Tablet, Route of administration: Oral
Drug: Tamoxi
Sponsors
Tanaka Tomoyuki
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 receptor 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 (invasive breast cancer) who have undergone breast surgery and adjuvant radiation (if indicated) for the current malignancy. - Who have received prior aromatase inhibitors (AIs) (letrozole, anastrozole or exemestane or any sequence thereof) per the following: Adjuvant AI therapy was discontinued due to AI treatment-related toxicity; Minimum of 6 months duration and maximum of 30 months duration (from initiation of first AI if there was a switch between AIs) of AI therapy is required - Absence of locoregional and/or advanced/metastatic disease - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 - Capable of giving signed informed consent
Exclusion criteria
Exclusion criteria: - Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant and/or tamoxifen. Participants unable to swallow normally or unable to take tablets 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 - History of prior breast cancer treated with 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 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. Prior treatment with raloxifene or tamoxifen for bone health, risk reduction, or a prior breast cancer is allowed provided this was discontinued at least 3 years before diagnosis of current breast cancer. - Ongoing treatment with HER2 directed therapy. Appropriate wash out between the last dose of HER2 directed therapy and randomization should be at least 4 weeks The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Invasive breast cancer-free survival (IBCFS) [ Time Frame: From randomization up to approximately 10 years ] IBCFS is defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence (IIBTR), local-regional invasive breast cancer recurrence, distant recurrence, invasive contralateral breast cancer, death attributable to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Invasive disease-free survival (IDFS) [ Time Frame: From randomization up to approximately 10 years ] IDFS is defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence (IIBTR), local-regional invasive breast cancer recurrence, distant recurrence, invasive contralateral breast cancer, second nonbreast primary invasive cancer, death attributable to any cause 2. Distant recurrence-free survival (DRFS) [ Time Frame: From randomization up to approximately 10 years ] DRFS is defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: distant recurrence or death attributable to any cause 3. Locoregional recurrences-free survival (LRRFS) [ Time Frame: From randomization up to approximately 10 years ] LRRFS is defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: local/regional ipsilateral recurrence, invasive contralateral breast cancer or death attributable to any cause 4. Overall survival (OS) [ Time Frame: From randomization up to approximately 10 years ] Overall survival is defined as the time interval from the date of randomization to the date of documented death (due to any cause) 5. Breast cancer-specific survival (BCSS) [ Time Frame: From randomization up to approximately 10 years ] BCSS is defined as the time interval from the date of randomization to the date of documented death attributable to breast cancer cause 6. Patient-reported overall treatment-related side effect bother as measured by the Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5) [ Time Frame: From baseline up to 2 years after the end of treatment (up to approximately 7 years) ] 7. Patient-reported treatment-related symptoms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questio | — |
Countries
Chile, China, Japan
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed