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New breast cancer drug shows promise in slowing tumor growth

NCT ID NCT04059484

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called amcenestrant against standard hormone therapies in 367 people with advanced ER+/HER2- breast cancer. The goal was to see if it could slow cancer growth better than current options. The trial was stopped early, but results help guide future treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

367 people

The number who actually took part.

Started

Oct 2019

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * Estrogen receptor(ER) positive status. * Human epidermal growth factor receptor 2 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 Cyclin-dependent kinase 4 and 6(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 amcenestrant. 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 greater than 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 least 3 months before randomization. * Treatment with drugs that have the potential to inhibit Uridine'5 Diphospho-Glucuronosyl Transferase(UGT) less than 2 weeks before randomization. * Treatment with strong Cytochrome P450 (CYP)3A inducers within 2 weeks before randomization. * Ongoing treatment with drugs that are sensitive substrate of organic anion transporting polypeptide 1B1/B3(OATP1B1/B3) (asunaprevir, atorvastatin, bosentan, danoprevir, fexofenadine, glyburide, nateglinide, pitavastatin, pravastatin, replaglinide, rosuvastatin, and simvastatin acid). * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer estrogen-receptor positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer, metastatic

Contacts and locations

Locations

  • Alabama Oncology - St. Vincent's Birmingham- Site Number : 8400008

    Birmingham, Alabama, 35205, United States

  • Associacao de Combate ao Cancer em Goias Hospital Araujo Jorge- Site Number : 0760005

    Goiânia, Goiás, 74605-070, Brazil

  • Comprehensive Blood and Cancer Center Site Number : 8400018

    Bakersfield, California, 93309, United States

  • Dana-Farber Cancer Institute- Site Number : 8400015

    Boston, Massachusetts, 02215, United States

  • Dartmouth-Hitchcock Medical Center - Lebanon - 1 Medical Center Drive- Site Number : 8400013

    Lebanon, New Hampshire, 03756, United States

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Gabrail Cancer Center- Site Number : 8400006

    Canton, Ohio, 44718, United States

  • Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400025

    Hackensack, New Jersey, 07601, United States

  • Hematology Oncology Clinic Site Number : 8400020

    Baton Rouge, Louisiana, 70809, United States

  • Hospital Auxilio Mutuo- Site Number : 8400028

    San Juan, 00918, Puerto Rico

  • Hospital Mae de Deus Site Number : 0760002

    Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

  • Hospital de Clinicas de Porto Alegre- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760006

    São Paulo, 04014-002, Brazil

  • Investigational Site Number : 0320001

    Buenos Aires, 1426, Argentina

  • Investigational Site Number : 0320002

    Salta, 4400, Argentina

  • Investigational Site Number : 0320004

    La Rioja, 5300, Argentina

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320006

    Buenos Aires, 1125, Argentina

  • Investigational Site Number : 0320007

    Buenos Aires, 1012, Argentina

  • Investigational Site Number : 0320008

    Buenos Aires, 1019, Argentina

  • Investigational Site Number : 0360001

    Nedlands, Western Australia, 6009, Australia

  • Investigational Site Number : 0360002

    Woolloongabba, Queensland, 4102, Australia

  • Investigational Site Number : 0360003

    South Brisbane, Queensland, 4101, Australia

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Charleroi, 6000, Belgium

  • Investigational Site Number : 0560003

    Namur, 5000, Belgium

  • Investigational Site Number : 1240003

    London, Ontario, N6A 5W9, Canada

  • Investigational Site Number : 1240004

    Calgary, Alberta, T2N 4N2, Canada

  • Investigational Site Number : 1240006

    Montreal, Quebec, H3T 1E2, Canada

  • Investigational Site Number : 1560001

    Beijing, 100021, China

  • Investigational Site Number : 1560002

    Hangzhou, 310022, China

  • Investigational Site Number : 1560003

    Kunming, Michigan, 650106, China

  • Investigational Site Number : 1560005

    Harbin, 150081, China

  • Investigational Site Number : 1560008

    Linyi, 276000, China

  • Investigational Site Number : 1560010

    Hefei, 230001, China

  • Investigational Site Number : 1560011

    Nanjing, 210029, China

  • Investigational Site Number : 1560013

    Tianjin, 300060, China

  • Investigational Site Number : 1560014

    Changsha, 410005, China

  • Investigational Site Number : 1560015

    Changchun, 130021, China

  • Investigational Site Number : 1560016

    Wuhan, 430079, China

  • Investigational Site Number : 1560018

    Hefei, 230022, China

  • Investigational Site Number : 1560021

    Ürümqi, 830000, China

  • Investigational Site Number : 1560023

    Hangzhou, 310016, China

  • Investigational Site Number : 1560024

    Chongqing, Maryland, 400030, China

  • Investigational Site Number : 1560025

    Chengdu, 610041, China

  • Investigational Site Number : 1560026

    Jinan, 250013, China

  • Investigational Site Number : 1560031

    Xuzhou, 221018, China

  • Investigational Site Number : 1580001

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    Taichung, 404, Taiwan

  • Investigational Site Number : 1580003

    Tainan, 704, Taiwan

  • Investigational Site Number : 1580004

    Taipei, 114, Taiwan

  • Investigational Site Number : 1580005

    Taipei, 104, Taiwan

  • Investigational Site Number : 2030002

    Brno, 656 53, Czechia

  • Investigational Site Number : 2030003

    Nový Jičín, 741 01, Czechia

  • Investigational Site Number : 2030004

    Prague, 140 59, Czechia

  • Investigational Site Number : 2500001

    Villejuif, 94805, France

  • Investigational Site Number : 2500005

    Paris, 75010, France

  • Investigational Site Number : 2500006

    Créteil, 94010, France

  • Investigational Site Number : 2500007

    Marseille, 13273, France

  • Investigational Site Number : 2500008

    Angers, 49055, France

  • Investigational Site Number : 3000001

    Heraklion, 711 10, Greece

  • Investigational Site Number : 3000002

    Larissa, 411 10, Greece

  • Investigational Site Number : 3000004

    Thessaloniki, Quebec, 546 45, Greece

  • Investigational Site Number : 3760001

    Petah Tikva, 4941492, Israel

  • Investigational Site Number : 3760002

    Jerusalem, 9103102, Israel

  • Investigational Site Number : 3760003

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760004

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3800001

    Candiolo, Torino, 10060, Italy

  • Investigational Site Number : 3800002

    Milan, Milano, 20141, Italy

  • Investigational Site Number : 3800003

    Prato, 59100, Italy

  • Investigational Site Number : 3920001

    Kashiwa, Chiba, 277-8577, Japan

  • Investigational Site Number : 3920002

    Nagoya, Aichi-ken, 464-8681, Japan

  • Investigational Site Number : 3920003

    Osaka, 540-0006, Japan

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0045, Japan

  • Investigational Site Number : 3920005

    Ina, Nagano, 362-0806, Japan

  • Investigational Site Number : 3920006

    Yokohama, Kanagawa, 241-0815, Japan

  • Investigational Site Number : 3920008

    Tokyo, 135-8550, Japan

  • Investigational Site Number : 3920009

    Ōta, Gunma, 373-8550, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4280001

    Riga, LV-1038, Latvia

  • Investigational Site Number : 4280002

    Riga, LV-1002, Latvia

  • Investigational Site Number : 4840002

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number : 4840005

    Mexico City, 03100, Mexico

  • Investigational Site Number : 4840006

    Veracruz, 91900, Mexico

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Investigational Site Number : 6160003

    Poznan, Greater Poland Voivodeship, 61-866, Poland

  • Investigational Site Number : 6430002

    Saint Petersburg, Georgia, 197758, Russia

  • Investigational Site Number : 6430003

    Moscow, 115478, Russia

  • Investigational Site Number : 6430005

    Moscow, 105005, Russia

  • Investigational Site Number : 7240001

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain

  • Investigational Site Number : 7240003

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240008

    Málaga, 29010, Spain

  • Investigational Site Number : 7920002

    Edirne, 22030, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Istanbul, 34722, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Ankara, 06200, Turkey (Türkiye)

  • Investigational Site Number : 8040001

    Kryvyi Rih, 50048, Ukraine

  • Investigational Site Number : 8040004

    Odesa, 65025, Ukraine

  • Investigational Site Number : 8040005

    Uzhhorod, 88000, Ukraine

  • Northwest Medical Specialties Tacoma- Site Number : 8400038

    Tacoma, Washington, 98405, United States

  • Saint Luke's Hospital of Kansas City- Site Number : 8400032

    Kansas City, Missouri, 64111, United States

  • The Center for Cancer & Blood Disorders - Fort Worth- Site Number : 8400022

    Fort Worth, Texas, 76104, United States

  • UCLA Santa Monica - Parkside- Site Number : 8400024

    Santa Monica, California, 90404, United States

  • University of Kansas Clinical Research Center- Site Number : 8400027

    Fairway, Kansas, 66205, United States

  • University of Vermont Medical Center- Site Number : 8400026

    Burlington, Vermont, 05401, United States

  • University of Wisconsin Hospitals and Clinics- Site Number : 8400016

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.