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Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4)

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: NCT04191382
Recruitment Status : Terminated (early discontinuation based on strategic sponsor decision not driven by any safety concerns)
First Posted : December 9, 2019
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 5, 2019
First Posted Date  ICMJE December 9, 2019
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE February 4, 2020
Actual Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
Ki67 [ Time Frame: Baseline and Day 15 ]
Change in Ki67 (percentage of positive tumor cells tested by immunohistochemistry) after a 14-day treatment period compared to baseline assessed by central reading
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
  • Ki67≥50% [ Time Frame: Baseline and Day 15 ]
    Proportion of participants with relative change from baseline in Ki67≥50% after a 14-day treatment period compared to baseline
  • ER Expression [ Time Frame: Baseline and Day 15 ]
    Change in ER expression after a 14-day treatment period compared to baseline
  • Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: Up to approximately Day 44 ]
    Percentage of participants with AEs/SAEs
  • Clinical Laboratory Test Abnormalities [ Time Frame: Up to Day 14 ]
    Percentage of participants with clinical laboratory test abnormalities
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
Official Title  ICMJE Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer
Brief Summary

Primary Objective:

To determine whether amcenestrant given at 2 different doses improves the antiproliferative activity when compared to letrozole

Secondary Objectives:

  • To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms
  • To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms
  • To assess safety in the three treatment arms
Detailed Description Duration of the study, per patient, will include screening period of up to 14 days before randomization, treatment period of 14 days and post-treatment safety follow-up period of 30±7 days after last Investigational Medicinal Product (IMP) intake.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: amcenestrant (SAR439859)
    Pharmaceutical form: Capsules Route of administration: Oral
  • Drug: letrozole
    Pharmaceutical form: Tablets Route of administration: Oral
Study Arms  ICMJE
  • Experimental: SAR439859 dose regimen 1
    SAR439859 dose regimen 1 administered for 14 days
    Intervention: Drug: amcenestrant (SAR439859)
  • Experimental: SAR439859 dose regimen 2
    SAR439859 dose regimen 2 administered for 14 days
    Intervention: Drug: amcenestrant (SAR439859)
  • Active Comparator: letrozole
    letrozole 2.5 mg administered once daily for 14 days
    Intervention: Drug: letrozole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 10, 2021)
105
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2019)
126
Actual Study Completion Date  ICMJE May 28, 2021
Actual Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Histological or cytological proven diagnosis of invasive breast adenocarcinoma
  • Localized breast cancer eligible for upfront breast conservative surgery or upfront mastectomy: Stage I, Stage II or operable Stage III (excludes T4) as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017
  • Postmenopausal women as defined by one of the following:
  • Spontaneous cessation of menses >12 months;
  • or who have received hormonal replacement therapy but have discontinued this treatment and have follicle stimulating hormone (FSH) level in the postmenopausal range;
  • or with status post bilateral surgical oophorectomy;
  • or post bilateral ovarian ablation through pelvic radiotherapy
  • Breast tumor size of at least 10 mm in greatest dimension measured by ultrasound
  • Primary tumor must be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor by immunohistochemistry
  • Ki67 level of at least 15% at diagnosis from immunohistochemistry of the tumor
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion criteria:

  • Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859 or letrozole; Participants unable to swallow normally and to take capsules or tablets
  • Participants with known active hepatitis A, B, C infection; or hepatic cirrhosis.
  • Participant with any other cancer; adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed
  • Evidence of metastatic spread by standard assessment according to local practice
  • Treatment with strong Cytochrome P450 3A (CYP3A) inducers or drugs that have the potential to inhibit uridine diphosphate glucuronosyltransferase (UGT) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever is longest
  • Treatment with drugs that are sensitive substrates of P-glycoprotein (P-gp) or of breast cancer resistance protein (BCRP) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever is longer.
  • Use of any investigational agent within 4 weeks prior to randomization
  • Recent use of hormone replacement therapy (last dose ≤30 days prior to randomization)
  • Prior anti-cancer treatment is not allowed unless it was completed at least 1 year prior to inclusion into this trial
  • Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments)
  • Inadequate hematological or renal function
  • Prothrombin time/international normalized ratio (INR) >1.5 x ULN or outside therapeutic range if receiving anticoagulation that would affect the prothrombin time/INR
  • Any of the following abnormal liver function test results: Aspartate aminotransferase >1.5 x upper limit of normal (ULN); Alanine aminotransferase >1.5 x ULN; Total bilirubin >1.5 x ULN
  • Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Italy,   Japan,   Korea, Republic of,   Puerto Rico,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04191382
Other Study ID Numbers  ICMJE ACT16106
2019-002015-26 ( EudraCT Number )
U1111-1228-9473 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP