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Trial record 1 of 1 for:    AMEERA-6
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05128773
Recruitment Status : Terminated (Sponsor decision to prematurely stop the study, not linked to any safety concern)
First Posted : November 22, 2021
Last Update Posted : October 24, 2022
Sponsor:
Collaborators:
Breast International Group
Alliance Foundation Trials, LLC.
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Amcenestrant Drug: Tamoxifen Drug: Amcenestrant-matching placebo Drug: Tamoxifen-matching placebo Phase 3

Detailed Description:
Study duration per participant is approximately 10 years.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-dummy
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 17, 2022
Actual Primary Completion Date : October 13, 2022
Actual Study Completion Date : October 13, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Amcenestrant with tamoxifen-matching placebo arm
Amcenestrant dose, once daily, continuously. Tamoxifen-matching placebo, once daily, continuously.
 Drug: Amcenestrant
tablet, oral

Drug: Tamoxifen-matching placebo
tablet, oral
Active Comparator: Tamoxifen with amcenestrant-matching placebo
Tamoxifen dose, once daily, continuously. Amcenestrant-matching placebo, once daily, continuously.
 Drug: Tamoxifen
tablet, oral

Drug: Amcenestrant-matching placebo
tablet, oral


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Questionnaire Breast cancer module (EORTC QLQ-B23) systemic therapy side effects scale [ Time Frame: From baseline up to 2 years after the end of treatment (up to approximately 7 years) ]
  8. Patient-reported quality of life as measured by the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) global health status/quality of life (GHQ) scale [ Time Frame: From baseline up to 2 years after the end of treatment (up to approximately 7 years) ]
  9. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Up to 30 days after the end of treatment, approximately 5 years ]
    Incidence of participants with TEAEs, SAEs and laboratory abnormalities

  10. PK parameter: Plasma concentration of Amcenestrant [ Time Frame: Pre-administration day 1 of cycles 2, 7, 13 and 25 (each cycle is 28 days) ]
    Predose plasma concentration of Amcenestrant


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05128773


Locations
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Sponsors and Collaborators
Sanofi
Breast International Group
Alliance Foundation Trials, LLC.
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Etienne Brain, MD PhD Institut Curie (Saint-Cloud and Paris), 35 rue Dailly, 92210 Saint-Cloud
Study Chair: David Cameron, Professor of Oncology University of Edinburgh Cancer Centre, institute of Genetics and Cancer, Western General Hospital, Crewe Road South, EDINBURGH EH4 2XU Scotland
Study Chair: Otto Metzger, MD Dana-Farber Cancer Institute, 450 Brookline Avenue Yawkey 1250
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT05128773    
Other Study ID Numbers: EFC16133
U1111-1244-1767 ( Registry Identifier: ICTRP )
BIG 20-01 ( Other Identifier: BIG )
AFT-55 ( Other Identifier: AFT )
EORTC-2033 ( Other Identifier: EORTC )
2021-000398-10 ( EudraCT Number )
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 21, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents