Study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer, who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity (AMEERA-6)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4670

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials