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Trial record 1 of 1 for:    04478266
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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 : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To determine whether SAR439859 in combination with palbociclib improves progression 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 the pharmacokinetics of SAR439859, goserelin, 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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole-matching placebo Drug: SAR439859-matching placebo Drug: SAR439859 Drug: Ibrance Drug: Letrozole Drug: Goserelin Phase 3

Detailed Description:
Study duration per participant is approximately 57 months, which includes a 24-month treatment period

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind Phase 3 Study of 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
Actual Study Start Date : October 14, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SAR439859 with Letrozole-matching placebo Arm

Participants in SAR439859 with Letrozole-matching placebo Arm will be administered: SAR439859 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.

Drug: Letrozole-matching placebo
Pharmaceutical form:Tablets Route of administration: Oral

Drug: SAR439859
Pharmaceutical form:Tablets Route of administration: Oral

Drug: Ibrance
Pharmaceutical form:Capsules/Tablets Route of administration: Oral

Drug: Goserelin
Pharmaceutical form:Depot Injection Route of administration: Subcutaneous

Active Comparator: Letrozole with SAR439859-matching placebo Arm
Participants in Letrozole with SAR439859-matching placebo Arm will be administered: Letrozole dose, once daily, continuously. SAR439859-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.
Drug: SAR439859-matching placebo
Pharmaceutical form:Tablets Route of administration: Oral

Drug: Ibrance
Pharmaceutical form:Capsules/Tablets Route of administration: Oral

Drug: Letrozole
Pharmaceutical form:Capsules/Tablets Route of administration: Oral

Drug: Goserelin
Pharmaceutical form:Depot Injection Route of administration: Subcutaneous




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization date to date of death (up to approximately 5 years) ]
    Overall survival is defined as the time interval from the date of randomization to the date of documented death (due to any cause).

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: From Baseline up to end of study (approximately 5 years) ]
    Incidence of participants with TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE V5.

  7. 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.

  8. 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 3.5 years) ]
    Change From Baseline between treatment comparison Using the European Quality of Life- 5-Dimension 5 Level (EQ-5D 5L).

  9. 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 3.5 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).

  10. 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 3.5 years) ]
    Change From Baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR45 (Breast) Questionnaire.

  11. 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 3.5 years) ]
    Change From Baseline between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire.



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 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 or non-measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Participants should be willing to provide tumor tissue
  • Capable of giving informed consent

Exclusion criteria:

  • Known brain metastases that are untreated, symptomatic or require treatment to control symptoms
  • 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 aromatase inhibitor-containing 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.


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): NCT04478266


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

Locations
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United States, California
Investigational Site Number 8400032 Recruiting
Torrance, California, United States, 90502
United States, Florida
Investigational Site Number 8400059 Recruiting
Lakeland, Florida, United States, 33805
United States, Georgia
Investigational Site Number 8400034 Recruiting
Savannah, Georgia, United States, 31405
Investigational Site Number 8400035 Recruiting
Thomasville, Georgia, United States, 31792
United States, New York
Investigational Site Number 8400023 Recruiting
Stony Brook, New York, United States, 11794-8121
Australia
Investigational Site Number 0360002 Recruiting
Richmond, Australia, 3121
Puerto Rico
Investigational Site Number 8400003 Recruiting
Hato Rey, Puerto Rico, 00917
Spain
Investigational Site Number 7240002 Recruiting
Madrid / Madrid, Spain, 28050
Investigational Site Number 7240001 Recruiting
Madrid Madrid, Spain, 28041
Investigational Site Number 7240004 Recruiting
Madrid, Spain, 28046
Investigational Site Number 7240003 Recruiting
Santiago De Compostela, Spain, 15706
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04478266    
Other Study ID Numbers: EFC15935
2020-001824-33 ( EudraCT Number )
U1111-1233-0486 ( Other Identifier: UTN )
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: November 25, 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/

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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
Letrozole
Goserelin
Palbociclib
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
Antineoplastic Agents, Hormonal
Protein Kinase Inhibitors