Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04478266
Previous Study | Return to List | Next Study

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (AMEERA-5)

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: NCT04478266
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 10, 2020
First Posted Date  ICMJE July 20, 2020
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE October 14, 2020
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2021)
Progression-free survival [ Time Frame: From randomization date to date of first documentation of progression OR death (up to approximately 4 years) ]
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever come first.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
Progression-free survival [ Time Frame: From randomization date to date of first documentation of progression OR death (up to approximately 3.5 years) ]
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever come first.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2021)
  • Overall Survival [ Time Frame: From randomization date to date of death (up to approximately 6 years) ]
    Overall survival is defined as the time interval from the date of randomization to the date of documented death (due to any cause).
  • Objective Response Rate [ Time Frame: From randomization date to end of treatment (up to approximately 4 years) ]
    Objective response rate is defined as the proportion of participants who have a CR or PR, as best overall response determined as per RECIST 1.1, from the date of randomization to the date of until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first.
  • Duration of Response [ Time Frame: From randomization date to end of treatment (up to approximately 4 years) ]
    Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined as per RECIST 1.1 or death from any cause, whichever occurs first.
  • Clinical Benefit Rate [ Time Frame: From randomization date to end of treatment (up to approximately 4 years) ]
    Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR, or SD for at least 24 weeks determined as per RECIST 1.1, from the date of randomization until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first
  • PK parameter: Plasma concentrations [ Time Frame: From randomization date to end of treatment (up to approximately 4 years) ]
    Plasma concentrations of Amcenestrant and palbociclib.
  • Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: From Baseline up to end of study (approximately 6.5 years) ]
    Incidence of participants with TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE V5
  • Time to First Chemotherapy [ Time Frame: From randomization date to end of treatment (up to approximately 4 years) ]
    Time to chemotherapy is defined as the time interval from the date of randomization to the start date of the first chemotherapy after study treatment discontinuation.
  • Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) [ Time Frame: From Baseline to 90 days after end of treatment (up to approximately 4 years) ]
    Change From Baseline between treatment comparison Using the European Quality of Life- 5-Dimension 5 Level (EQ-5D 5L).
  • Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30) [ Time Frame: From Baseline to 90 days after end of treatment (up to approximately 4 years) ]
    Change From Baseline between treatment comparison in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
  • Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR45) questionnaire [ Time Frame: From Baseline to 90 days after end of treatment (up to approximately 4 years) ]
    Change From Baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR45 (Breast) Questionnaire.
  • Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR23) questionnaire [ Time Frame: From Baseline to 90 days after end of treatment (up to approximately 4 years) ]
    Change From Baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire.
  • Progression-free survival on next line of therapy (PFS2) [ Time Frame: From randomization date to date of death (up to approximately 6.5 years) ]
    PFS2 is defined as the time from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator or death due to any cause, whichever occurs first.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • Overall Survival [ Time Frame: From randomization date to date of death (up to approximately 6 years) ]
    Overall survival is defined as the time interval from the date of randomization to the date of documented death (due to any cause).
  • Objective Response Rate [ Time Frame: From randomization date to end of treatment (up to approximately 3.5 years) ]
    Objective response rate is defined as the proportion of participants who have a CR or PR, as best overall response determined as per RECIST 1.1, from the date of randomization to the date of until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first.
  • Duration of Response [ Time Frame: From randomization date to end of treatment (up to approximately 3.5 years) ]
    Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined as per RECIST 1.1 or death from any cause, whichever occurs first.
  • Clinical Benefit Rate [ Time Frame: From randomization date to end of treatment (up to approximately 3.5 years) ]
    Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR, or SD for at least 24 weeks determined as per RECIST 1.1, from the date of randomization until disease progression, death, cutoff date, initiation of post-treatment anti-cancer therapy, whichever occurs first.
  • PK parameter: Plasma concentrations [ Time Frame: From randomization date to end of treatment (up to approximately 3.5 years) ]
    Plasma concentrations of SAR439859, goserelin and palbociclib
  • Change From Baseline between treatment comparison Using the European Quality of Life- 5-Dimension 5 Level (EQ-5D 5L) [ Time Frame: From Baseline to 90 days after end of treatment (up to approximately 3.5 years) ]
    Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L).
  • Change From Baseline between treatment comparison in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: From Baseline to 90 days after end of treatment (up to approximately 3.5 years) ]
    Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30).
  • Change From Baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR45 (Breast) Questionnaire [ Time Frame: From Baseline to 90 days after end of treatment (up to approximately 3.5 years) ]
    Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR45) questionnaire.
  • Time to First Chemotherapy [ Time Frame: From randomization date to end of treatment (up to approximately 3.5 years) ]
    Time to chemotherapy is defined as the time interval from the date of randomization to the start date of the first chemotherapy after study treatment discontinuation.
  • Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: From Baseline up to end of study (approximately 6 years) ]
    Incidence of participants with TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE V5
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Official Title  ICMJE A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Brief Summary

Primary Objective:

To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Secondary Objective:

  • To compare the overall survival in both treatment arms
  • To evaluate the objective response rate in both treatment arms
  • To evaluate the duration of response in both treatment arms
  • To evaluate the clinical benefit rate in both treatment arms
  • To evaluate progression-free survival on next line of therapy
  • To evaluate the pharmacokinetics of amcenestrant, and palbociclib
  • To evaluate health-related quality of life in both treatment arms
  • To evaluate the time to first chemotherapy in both treatment arms
  • To evaluate safety in both treatment arms
Detailed Description Study duration per participant is approximately 64 months, which includes a 33- month treatment period
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Amcenestrant-matching placebo
    Pharmaceutical form: Tablets Route of Administration: Oral
  • Drug: SAR439859
    Pharmaceutical form: Tablets Route of Administration: Oral
    Other Name: Amcenestrant
  • Drug: Palbociclib
    Pharmaceutical form: Capsules/Tablets Route of Administration: Oral
    Other Name: Ibrance
  • Drug: Letrozole
    Pharmaceutical form: Tablets Route of Administration: Orally
  • Drug: Goserelin
    Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous
  • Drug: Letrozole-matching placebo
    Pharmaceutical form: Tablets Route of Administration: Orally
Study Arms  ICMJE
  • Experimental: Amcenestrant with Letrozole-matching placebo Arm
    Participants in Amcenestrant with Letrozole-matching placebo Arm will be administered: Amcenestrant dose, once daily, continuously. Letrozole-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle. Goserelin once every 4 weeks in pre/peri menopausal women and men
    Interventions:
    • Drug: SAR439859
    • Drug: Palbociclib
    • Drug: Goserelin
    • Drug: Letrozole-matching placebo
  • Active Comparator: Letrozole with Amcenestrant matching placebo Arm
    Participants in Letrozole with Amcenestrant-matching placebo Arm will be administered: Letrozole dose, once daily, continuously. Amcenestrant-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle Goserelin once every 4 weeks in pre/peri menopausal women and men
    Interventions:
    • Drug: Amcenestrant-matching placebo
    • Drug: Palbociclib
    • Drug: Letrozole
    • Drug: Goserelin
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2021)
1066
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)
708
Estimated Study Completion Date  ICMJE August 2027
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
  • Confirmed diagnosis of ER+/HER2- breast cancer
  • No prior systemic treatment for loco-regional recurrent or metastatic disease
  • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants should be willing to provide tumor tissue
  • Capable of giving informed consent

Exclusion criteria:

  • Known active brain metastases
  • Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
  • Inadequate organ and marrow function
  • Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy
  • Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
  • Male participants who disagree to follow contraception
  • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
  • Participants with significant concomitant illness

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: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Czechia,   Estonia,   Finland,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04478266
Other Study ID Numbers  ICMJE EFC15935
2020-001824-33 ( EudraCT Number )
U1111-1233-0486 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
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