*AMEERA-6
Research type
Research Study
Full title
A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative or positive, stage IIB-III breast cancer who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity
IRAS ID
1005027
Contact name
NA NA
Contact email
Sponsor organisation
Sanofi-aventis recherche & développement
Eudract number
2021-000398-10
Clinicaltrials.gov Identifier
Research summary
This trial is for people with breast cancer expressing estrogen receptors and/or progesterone receptors which may help the cancer grow. After the patients have surgery, the next step is to lower the risk of recurrence and to get rid of any remaining cancer cells in the body (adjuvant therapy). Adjuvant therapies such as hormonal therapies block hormone actions or lower hormone levels in the body. Aromatase inhibitors have been proven to be effective treatment but can have side effects causing premature treatment discontinuation.
This trial aims to improve the efficacy of hormonal adjuvant therapy by using an experimental drug amcenestrant, an oral selective estrogen receptor degrader (SERD) that may act in the body by reducing estrogens and the risk of breast cancer recurrence. Tolerability of amcenestrant will also be assessed. We will compare treatment with amcenestrant against standard tamoxifen in patients who have prematurely ended their adjuvant aromatase inhibitor therapy due to side effects.
Treatment will be randomly chosen for each patient meaning determined by chance using a computer program. There will be two groups of patients and each group will receive a different treatment:
• One tablet of amcenestrant once daily combined with one tablet of placebo of tamoxifen
• OR one tablet of tamoxifen once daily combined with one tablet of placebo of amcenestrant.
A placebo is a dummy treatment containing no active medicine.Each patient will have a one out of two chance (50%) of receiving amcenestrant. This study is a double-blind trial which means neither patients, doctors or researchers will know which treatment is assigned until the trial is over. Both treatments on this trial last for the same length of time (5 years), with a 5 year follow up period.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0187
Date of REC Opinion
13 May 2022
REC opinion
Further Information Favourable Opinion