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Trial record 1 of 1 for:    ACT16105 | Bakersfield, California, U.S.
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Phase 2 Study of SAR439859 Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3)

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: NCT04059484
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To determine whether SAR439859 per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer.

Secondary Objectives:

  • To compare the overall survival in the 2 treatment arms
  • To assess the objective response rate in the 2 treatment arms.
  • To evaluate the disease control rate in the 2 treatment arms.
  • To evaluate the clinical benefit rate in the 2 treatment arms.
  • To evaluate the duration of response in the 2 treatment arms.
  • To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms.
  • To evaluate the pharmacokinetics of SAR439859 as single agent.
  • To evaluate health related quality of life in the 2 treatment arms.
  • To compare the overall safety profile in the 2 treatment arms.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Drug: SAR439859 Drug: Fulvestrant Drug: Anastrozole Drug: Letrozole Drug: Exemestane Drug: Tamoxifen Phase 2

Detailed Description:

The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days of study treatment), and an end of treatment (EOT) visit at least 30 days (or until the participant receive another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, death or upon participant's request.

An extension of recruitment for Chinese participants is planned in this study: After completion of randomization in the global part of the study, randomization will continue in China until approximately 90 Chinese participants are randomized.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Phase 2 Trial of SAR439859, Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies (AMEERA-3)
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SAR439859
Daily SAR439859 dose administered orally under fed or fast condition
Drug: SAR439859

Pharmaceutical form: Capsule

Route of administration: Oral


Active Comparator: Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator

Control treatment of the choice of the physician depending on each participant's medical condition and in accordance with the approved label may include 1 of the following treatments used as monotherapy.

Fulvestrant

Aromatase inhibitors (anastrozole, letrozole, exemestane)

Selective estrogen receptor modulator (Tamoxifen)

Drug: Fulvestrant

Pharmaceutical form: Solution for injection

Route of administration: Intramuscular

Other Name: Faslodex®

Drug: Anastrozole

Pharmaceutical form:Tablets or capsules

Route of administration: Oral

Other Name: Arimidex®/Anastrozole Generics

Drug: Letrozole

Pharmaceutical form: Tablets or capsules

Route of administration: Oral

Other Name: Femara®/Letrozole Generics

Drug: Exemestane

Pharmaceutical form: Tablets or capsules

Route of administration: Oral

Other Name: Aromasin®/Exemestane Generics

Drug: Tamoxifen

Pharmaceutical form: Tablets or capsules

Route of administration: Oral

Other Name: Nolvadex®/Tamoxifen Generics




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to 18 months after the first randomized participant ]
    PFS is defined as the time interval from the date of randomization to the date of documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever comes first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 64 months after the first randomized participant ]
    OS 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 (ORR) [ Time Frame: Up to 18 months after the first randomized participant ]
    ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR), as best overall response determined by RECIST 1.1 from the date of randomization to the date of end of treatment.

  3. Disease Control Rate (DCR) [ Time Frame: Up to 18 months after the first randomized participant ]
    DCR is defined as the proportion of participants who have a confirmed CR, PR, or stable disease (SD) determined by RECIST 1.1 from the date of randomization to the date of end of treatment.

  4. Clinical Benefit Rate (CBR) [ Time Frame: Up to 18 months after the first randomized participant ]
    CBR is defined as the proportion of participants who have a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by RECIST 1.1 from the date of randomization to the date of end of treatment.

  5. Duration of Response (DOR) [ Time Frame: Up to 18 months after the first randomized participant ]
    DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by objective radiographic disease assessment per RECIST 1.1 or death from any cause, whichever occurs first.

  6. PFS according to (ESR1) mutation status [ Time Frame: Up to 18 months after the first randomized participant ]
    PFS as per the estrogen receptor 1 (ESR1) mutation status determined at study entry.

  7. Assessments of the Pharmacokinetic (PK) parameter of SAR439859 as single agent: Plasma Concentrations [ Time Frame: Day 1 and Day 15 of Cycle 1 and Day 1 of cycles 3, 4 and 6 (each cycle is 28 days) ]
    SAR439859 plasma concentrations.

  8. Patient Reported Outcome (PRO) - health-related quality of life and health status using the European Quality of Life-5 Dimensions (EQ-5D) [ Time Frame: Day 1 of Cycle 1 and day 1 of subsequent cycle every 2 cycles up to 30 days after last study treatment (each cycle is 28 days) ]
    EQ-5D is a standardized measure of health status.

  9. Patient Reported Outcome (PRO) - the European Organisation for Research and Treatment of Cancer core quality of life questionnaire (EORTC-QLQ-C30) [ Time Frame: Day 1 of Cycle 1 and day 1 of subsequent cycle every 2 cycles up to 30 days after last study treatment (each cycle is 28 days) ]
    The EORTC-QLQ-C30 is composed of both multi item scales and single item measures. These include 5 functional scales, 3 symptom scales, a Global Health Status (GHS)/quality of life scale, and 6 single items.

  10. Patient Reported Outcome (PRO) - EORTC-QLQ breast cancer (EORTC-QLQ-BR23) [ Time Frame: Day 1 of Cycle 1 and day 1 of subsequent cycle every 2 cycles up to 30 days after last study treatment (each cycle is 28 days) ]
    The EORTC-QLQ-BR23 contains 23 items: 8 assessing function and 15 items assessing symptoms of disease or treatment.

  11. Overall safety profile - Treatment-Emergent Adverse events [ Time Frame: Evaluated continuously throughout study from the date of enrollment, up to 30 days after last study treatment administration ]
    Number of participants with treatment-emergent adverse events (TEAEs).



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 :

  • 18 years or older.
  • Histological or cytological diagnosis of adenocarcinoma of the breast.
  • Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
  • ER positive status.
  • HER2 negative status.
  • Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
  • In the main study, a prior treatment with a CDK 4/6 inhibitor is mandatory if this treatment is approved and can be reimbursed for this participant. The percentage of participants without previous CDK 4/6 inhibitor will be capped to 20%. In the Chinese extension cohort, previous treatment with a CDK 4/6 inhibitor will not be mandatory, and there will be no limitation to the number of participants naïve to CDK4/6 inhibitor.
  • Participants must present a secondary endocrine resistance to endocrine therapy defined as: progression while on endocrine therapy after at least 6 months of treatment for advanced breast cancer, or relapse while on adjuvant endocrine therapy but after the first 2 years, or with a relapse within 12 months after completing adjuvant endocrine therapy.
  • Male or Female.

Exclusion criteria:

  • Eastern Cooperative Oncology Group performance status ≥2.
  • Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859. Participants unable to swallow normally and to take capsules.
  • 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.
  • Severe uncontrolled systemic disease at screening.
  • Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms.
  • Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader (SERD) compound, except fulvestrant if stopped for at least3 months before randomization.
  • Treatment with drugs that have the potential to inhibit UGT less than 2 weeks before randomization .
  • Treatment with strong or moderate CYP3A/CYP2C8 inducers within 2 weeks before randomization.
  • Ongoing treatment with drugs that are substrate of P-glycoprotein (P gp) (dabigatran, digoxin, fexofenadine).
  • Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
  • Inadequate hematological, coagulation, renal and liver functions.

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): NCT04059484


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
Hide Hide 122 study locations
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United States, Alabama
Investigational Site Number 8400008 Recruiting
Birmingham, Alabama, United States, 35205
United States, California
Investigational Site Number 8400018 Recruiting
Bakersfield, California, United States, 93309
Investigational Site Number 8400024 Recruiting
Santa Monica, California, United States, 90404
Investigational Site Number 8400019 Recruiting
Woodland, California, United States, 95695
United States, Florida
Investigational Site Number 8400029 Recruiting
Fort Lauderdale, Florida, United States, 33308
United States, Illinois
Investigational Site Number 8400017 Recruiting
Chicago, Illinois, United States, 60612
Investigational Site Number 8400005 Recruiting
Chicago, Illinois, United States, 60637
Investigational Site Number 8400012 Recruiting
Tinley Park, Illinois, United States, 60487
Investigational Site Number 8400031 Recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Investigational Site Number 8400034 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Investigational Site Number 8400027 Recruiting
Fairway, Kansas, United States, 66205
United States, Louisiana
Investigational Site Number 8400020 Recruiting
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
Investigational Site Number 8400036 Recruiting
Silver Spring, Maryland, United States, 20902
United States, Massachusetts
Investigational Site Number 8400015 Recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Investigational Site Number 8400032 Recruiting
Kansas City, Missouri, United States, 64111
United States, Montana
Investigational Site Number 8400003 Recruiting
Billings, Montana, United States, 59101
United States, New Hampshire
Investigational Site Number 8400013 Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Investigational Site Number 8400025 Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Investigational Site Number 8400009 Recruiting
Jamaica, New York, United States, 11432
United States, North Carolina
Investigational Site Number 8400030 Recruiting
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Investigational Site Number 8400006 Recruiting
Canton, Ohio, United States, 44718
United States, Oklahoma
Investigational Site Number 8400014 Recruiting
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Investigational Site Number 8400001 Recruiting
Philadelphia, Pennsylvania, United States, 19124
Investigational Site Number 8400023 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Investigational Site Number 8400022 Recruiting
Fort Worth, Texas, United States, 76104
United States, Vermont
Investigational Site Number 8400026 Recruiting
Burlington, Vermont, United States, 05401
United States, Washington
Investigational Site Number 8400038 Recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Investigational Site Number 8400016 Recruiting
Madison, Wisconsin, United States, 53792
Argentina
Investigational Site Number 0320003 Recruiting
Buenos Aires, Argentina, C1120AAT
Investigational Site Number 0320006 Recruiting
Buenos Aires, Argentina, C1125ABD
Investigational Site Number 0320008 Recruiting
Caba, Argentina, C1019ABS
Investigational Site Number 0320007 Recruiting
Capital Federal, Argentina, 1012
Investigational Site Number 0320004 Recruiting
La Rioja, Argentina, 5300
Investigational Site Number 0320005 Recruiting
Rosario, Argentina, 2000
Investigational Site Number 0320002 Recruiting
Salta, Argentina, 4400
Australia
Investigational Site Number 0360001 Recruiting
Nedlands, Australia, 6009
Investigational Site Number 0360003 Recruiting
South Brisbane, Australia, 4101
Investigational Site Number 0360002 Recruiting
Woolloongabba, Australia, 4102
Belgium
Investigational Site Number 0560002 Recruiting
Charleroi, Belgium, B-6000
Investigational Site Number 0560001 Recruiting
Leuven, Belgium, 3000
Investigational Site Number 0560003 Recruiting
Namur, Belgium, 5000
Brazil
Investigational Site Number 0760005 Recruiting
Goiania, Brazil, 74605-070
Investigational Site Number 0760001 Recruiting
Porto Alegre, Brazil, 90035 003
Investigational Site Number 0760002 Recruiting
Porto Alegre, Brazil, 90470-340
Investigational Site Number 0760006 Recruiting
Sao Paulo, Brazil, 03102-002
Investigational Site Number 0760003 Recruiting
São José Do Rio Preto, Brazil, 15090-000
Canada
Investigational Site Number 1240004 Recruiting
Calgary, Canada, T2N 4N2
Investigational Site Number 1240002 Recruiting
Cambridge, Canada, N1R 3G2
Investigational Site Number 1240003 Recruiting
London, Canada, N6A 5W9
Investigational Site Number 1240006 Recruiting
Montreal, Canada, H3T 1E2
Investigational Site Number 1240005 Recruiting
St-Jerome, Canada, J7Z 5T3
China
Investigational Site Number 1560015 Recruiting
Changchun, China, 130021
Investigational Site Number 1560023 Recruiting
Hangzhou, China, 310016
Investigational Site Number 1560026 Recruiting
Jinan, China, 250013
Investigational Site Number 1560008 Recruiting
Linyi, China, 276000
Investigational Site Number 1560016 Recruiting
Wuhan, China, 430079
Investigational Site Number 1560032 Recruiting
Xuzhou, China, 221002
Czechia
Investigational Site Number 2030002 Recruiting
Brno, Czechia, 65653
Investigational Site Number 2030003 Recruiting
Novy Jicin, Czechia, 741 01
Investigational Site Number 2030004 Recruiting
Praha 4, Czechia, 14059
France
Investigational Site Number 2500008 Recruiting
Angers Cedex 9, France, 49933
Investigational Site Number 2500006 Recruiting
Creteil Cedex, France, 94010
Investigational Site Number 2500007 Recruiting
Marseille, France, 13009
Investigational Site Number 2500005 Recruiting
Paris, France, 75010
Investigational Site Number 2500002 Recruiting
Saint-Herblain, France, 44805
Investigational Site Number 2500001 Recruiting
Villejuif Cedex, France, 94805
Greece
Investigational Site Number 3000003 Recruiting
Athens, Greece, 14564
Investigational Site Number 3000002 Recruiting
Larissa, Greece, 41110
Israel
Investigational Site Number 3760002 Recruiting
Jerusalem, Israel, 9103102
Investigational Site Number 3760001 Recruiting
Petah-Tikva, Israel, 49100
Investigational Site Number 3760003 Recruiting
Tel Aviv, Israel, 64239
Investigational Site Number 3760004 Recruiting
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 3800001 Recruiting
Candiolo, Italy, 10060
Investigational Site Number 3800002 Recruiting
Milano, Italy, 20141
Investigational Site Number 3800003 Recruiting
Prato, Italy, 59100
Japan
Investigational Site Number 3920007 Recruiting
Chiba-Shi, Japan
Investigational Site Number 3920004 Recruiting
Chuo-Ku, Japan
Investigational Site Number 3920001 Recruiting
Kashiwa-Shi, Japan
Investigational Site Number 3920005 Recruiting
Kitaadachi-Gun, Japan
Investigational Site Number 3920008 Recruiting
Koto-Ku, Japan
Investigational Site Number 3920002 Recruiting
Nagoya-Shi, Japan
Investigational Site Number 3920003 Recruiting
Osaka-Shi, Japan
Investigational Site Number 3920009 Recruiting
Ota-Shi, Japan
Investigational Site Number 3920006 Recruiting
Yokohama-Shi, Japan
Korea, Republic of
Investigational Site Number 4100001 Recruiting
Seoul, Korea, Republic of, 03080
Investigational Site Number 4100004 Recruiting
Seoul, Korea, Republic of, 03722
Investigational Site Number 4100003 Recruiting
Seoul, Korea, Republic of, 05505
Investigational Site Number 4100002 Recruiting
Seoul, Korea, Republic of, 06351
Mexico
Investigational Site Number 4840005 Recruiting
Mexico, Mexico, 03100
Investigational Site Number 4840002 Recruiting
Monterrey, Mexico, 64460
Investigational Site Number 4840006 Recruiting
Veracruz, Mexico, 91910
Poland
Investigational Site Number 6160004 Recruiting
Pila, Poland, 64-920
Investigational Site Number 6160003 Recruiting
Poznan, Poland, 61-866
Investigational Site Number 6160001 Recruiting
Warszawa, Poland, 02-781
Investigational Site Number 6160002 Recruiting
Wieliszew, Poland
Puerto Rico
Investigational Site Number 8400028 Recruiting
Ponce De León, Puerto Rico, 00917
Russian Federation
Investigational Site Number 6430001 Recruiting
Moscow, Russian Federation, 111123
Investigational Site Number 6430003 Recruiting
Moscow, Russian Federation, 115478
Investigational Site Number 6430002 Recruiting
Saint -Petersburg, Russian Federation, 197758
Investigational Site Number 6430004 Recruiting
Saint-Petersburg, Russian Federation, 197022
Spain
Investigational Site Number 7240007 Recruiting
Barcelona, Spain, 08003
Investigational Site Number 7240006 Recruiting
Barcelona, Spain, 08035
Investigational Site Number 7240003 Recruiting
Barcelona, Spain, 08036
Investigational Site Number 7240009 Recruiting
Córdoba, Spain, 14004
Investigational Site Number 7240001 Recruiting
Hospitalet De Llobregat, Spain, 08908
Investigational Site Number 7240002 Recruiting
Madrid, Spain, 28033
Investigational Site Number 7240008 Recruiting
Málaga, Spain, 29010
Investigational Site Number 7240005 Recruiting
Pamplona, Spain, 31008
Investigational Site Number 7240004 Recruiting
Reus, Spain, 43201
Taiwan
Investigational Site Number 1580002 Recruiting
Taichung, Taiwan, 40447
Investigational Site Number 1580003 Recruiting
Tainan, Taiwan, 704
Investigational Site Number 1580001 Recruiting
Taipei, Taiwan, 10018
Investigational Site Number 1580005 Recruiting
Taipei, Taiwan, 104
Investigational Site Number 1580004 Recruiting
Taipei, Taiwan, 114
Turkey
Investigational Site Number 7920004 Recruiting
Ankara, Turkey, 06200
Investigational Site Number 7920002 Recruiting
Edirne, Turkey, 22030
Investigational Site Number 7920001 Recruiting
Istanbul, Turkey, 34303
Investigational Site Number 7920003 Recruiting
Istanbul, Turkey, 34722
Ukraine
Investigational Site Number 8040006 Recruiting
Kharkiv, Ukraine, 61103
Investigational Site Number 8040001 Recruiting
Kryvyi Rih, Ukraine, 50048
Investigational Site Number 8040004 Recruiting
Odesa, Ukraine, 65025
Investigational Site Number 8040005 Recruiting
Uzhgorod, Ukraine, 88000
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: NCT04059484    
Other Study ID Numbers: ACT16105
2018-004593-98 ( EudraCT Number )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 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
Tamoxifen
Letrozole
Fulvestrant
Anastrozole
Exemestane
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
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Estrogen Receptor Antagonists