Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    04191382
Previous Study | Return to List | Next Study

Phase 2 Window Study of SAR439859 Versus Letrozole in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191382
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To determine whether SAR439859 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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: SAR439859 Drug: letrozole Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Window Study of Two Dose Levels of SAR439859 (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer (AMEERA-4)
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: SAR439859 dose regimen 1
SAR439859 dose regimen 1 administered for 14 days
Drug: SAR439859
Pharmaceutical form: Capsules Route of administration: Oral

Experimental: SAR439859 dose regimen 2
SAR439859 dose regimen 2 administered for 14 days
Drug: SAR439859
Pharmaceutical form: Capsules Route of administration: Oral

Active Comparator: letrozole
letrozole 2.5 mg administered once daily for 14 days
Drug: letrozole
Pharmaceutical form: Tablets Route of administration: Oral




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. ER Expression [ Time Frame: Baseline and Day 15 ]
    Change in ER expression after a 14-day treatment period compared to baseline

  3. Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: Up to approximately Day 44 ]
    Percentage of participants with AEs/SAEs

  4. Clinical Laboratory Test Abnormalities [ Time Frame: Up to Day 14 ]
    Percentage of participants with clinical laboratory test abnormalities



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • 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 or moderate Cytochrome P450 3A (CYP3A), CYP2C8 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
  • Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (P-gp)
  • 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.


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): NCT04191382


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04191382    
Other Study ID Numbers: ACT16106
2019-002015-26 ( EudraCT Number )
U1111-1228-9473 ( Other Identifier: UTN )
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
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://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs