Breast Cancer Clinical Trial

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

Summary

This is a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in patients with hormone receptor-positive early breast cancer who have discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity. The primary objective is to demonstrate the superiority of amcenestrant versus tamoxifen on invasive breast cancer-free survival.

The treatment duration per participant will be 5 years, followed with a subsequent 5-years follow-up period. For the treatment period, visits are scheduled at the start of treatment, then at 4 weeks and 12 weeks after treatment start, and then every 12 weeks for the first 2 years and every 24 weeks for year 3 to 5. For the follow-up period, visits are scheduled 30 days after last treatment and then every 12 months. Three periods are planned:

A screening period of up to 28 days,
A treatment period of up to 5 years,
A follow-up period of up to 5 years.

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Full Description

Study duration per participant is approximately 10 years.

View Eligibility Criteria

Eligibility 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:

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 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 The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

3

Study ID:

NCT05128773

Recruitment Status:

Terminated

Sponsor:

Sanofi

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There are 54 Locations for this study

See Locations Near You

Investigational Site Number :0560150
Aalst , 9300, Belgium
Investigational Site Number :0560101
Anderlecht , 1070, Belgium
Investigational Site Number :0560147
Leuven , 3000, Belgium
Investigational Site Number :0561201
Namur , 5000, Belgium
Investigational Site Number :0569456
Sint Niklaas , 9100, Belgium
Investigational Site Number :0560151
Turnhout , 2300, Belgium
Investigational Site Number :1521622
Santiago Reg Metropolitana De Santiago, , Chile
Investigational Site Number :1561649
Beijing , 10014, China
Investigational Site Number :1561590
Beijing , 10073, China
Investigational Site Number :1561592
Chongqing , 40001, China
Investigational Site Number :1561643
Guangzhou , 51051, China
Investigational Site Number :1561599
Haikou , 57031, China
Investigational Site Number :1561677
Hangzhou , 31000, China
Investigational Site Number :1561717
Hangzhou , 31001, China
Investigational Site Number :1561675
Jinan , 25001, China
Investigational Site Number :1561674
Jinan , 25011, China
Investigational Site Number :1561715
Jining , , China
Investigational Site Number :1561676
Linyi , 27600, China
Investigational Site Number :1561726
Luoyang , , China
Investigational Site Number :1561870
Nanjing , 21000, China
Investigational Site Number :1561594
Nanning , 53002, China
Investigational Site Number :1561641
Neijiang , 64100, China
Investigational Site Number :1561587
Shanghai , 20003, China
Investigational Site Number :1561595
Shenzhen , 51802, China
Investigational Site Number :1561727
Suzhou , 21500, China
Investigational Site Number :1561591
Tianjin , 30006, China
Investigational Site Number :1561714
Weihai , 04600, China
Investigational Site Number :1561719
Wuhan , 43002, China
Investigational Site Number :1561718
Wuhan , 43003, China
Investigational Site Number :1561642
Wuhan , 43007, China
Investigational Site Number :1561683
Xiangyang , 44102, China
Investigational Site Number :1561648
Xuzhou , 22100, China
Investigational Site Number :1561597
Yinchuan , 75000, China
Investigational Site Number :1561680
Yuncheng , 04400, China
Investigational Site Number :2681693
Tbilisi , 0112, Georgia
Investigational Site Number :2681695
Tbilisi , 0159, Georgia
Investigational Site Number :2681694
Tbilisi , 0168, Georgia
Investigational Site Number :2686941
Tbilisi , 0176, Georgia
Investigational Site Number :3929173
Chiba-shi Chiba, 260-8, Japan
Investigational Site Number :3921721
Matsuyama-shi Ehime, 791-0, Japan
Investigational Site Number :3921152
Gifu-shi Gifu, 501-1, Japan
Investigational Site Number :3921173
Hiroshima-shi Hiroshima, 734-8, Japan
Investigational Site Number :3929170
Sapporo-shi Hokkaido, 003-0, Japan
Investigational Site Number :3921759
Sapporo-shi Hokkaido, 060-8, Japan
Investigational Site Number :3921861
Kagoshima-shi Kagoshima, 892-0, Japan
Investigational Site Number :3921835
Sendai-shi Miyagi, 980-8, Japan
Investigational Site Number :3921824
Yao-shi Osaka, 581-0, Japan
Investigational Site Number :3921764
Shinjuku-ku Tokyo, 160-0, Japan
Investigational Site Number :3921475
Shinjuku-ku Tokyo, 162-8, Japan
Investigational Site Number :4109184
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Investigational Site Number :4109183
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Investigational Site Number :4109186
Seoul Seoul-teukbyeolsi, 03722, Korea, Republic of
Investigational Site Number :4109224
Seoul Seoul-teukbyeolsi, 135-7, Korea, Republic of
Investigational Site Number :4109699
Seoul , 06591, Korea, Republic of
Investigational Site Number :4101190
Seoul , 2841, Korea, Republic of
Investigational Site Number :4101632
Seoul , 3181, Korea, Republic of
Investigational Site Number :4841630
Toluca de Lerdo Ciudad De Mexico, 50090, Mexico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

3

Study ID:

NCT05128773

Recruitment Status:

Terminated

Sponsor:


Sanofi

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