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
- Conditions
- Breast cancerMedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000398-10-HU
- Lead Sponsor
- Sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 4670
-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 discontuined due to AI treatment-related toxicity;
Minimum of 6 months duration and maximum of 30 months duration (from initiation of the 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
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
-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 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 selective estrogen receptor degrader (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
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