New drug duo aims to stall advanced breast cancer

NCT ID NCT04711252

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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

Summary

This study tests a new oral drug, camizestrant, combined with palbociclib against the standard anastrozole plus palbociclib in people with ER-positive, HER2-negative advanced breast cancer who haven't had prior treatment for advanced disease. About 1,370 participants will be followed to see which combo delays cancer growth longer. The goal is to improve disease control, not to cure the cancer.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,370 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Feb 2029

An estimate. End dates often move.

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 to 130 years

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 Full list of inclusion criteria * Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment. * De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation. * Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results. * Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease. * Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate organ and marrow function. * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. INFORMATION FOR TRIAL PARTICIPANTS Participants can join the trial if they: * Have breast cancer that cannot be treated with surgery or radiation * Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment * Have ER proteins but not overexpression of HER2 protein in their tumors * Have never received any type of cancer therapy that affects the whole body for advanced breast cancer * Are able to do their daily activities EXCLUSION CRITERIA Full list of exclusion criteria * Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. * Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant. * Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. * Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term and/or impending visceral crisis * Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. * Any clinically important and symptomatic heart disease . * Currently pregnant (confirmed with positive pregnancy test) or breast-feeding. * As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. * Any concurrent anti-cancer treatment. * Active infection including tuberculosis, HBV and HCV. INFORMATION FOR TRIAL PARTICIPANTS Participants cannot join the trial if they: * Have uncontrolled cancer that has spread to the brain or the spinal cord * Have received certain treatments for cancer in the past but the cancer came back within 1 year * Had certain types of tumors in the past, which the study doctors think could come back * Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body * Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant 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 disorder breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer neoplasm Neoplasm Metastasis Neoplasms by Site skin disorder

As listed by the trial registrant

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

ER-positive HER2-negative breast cancer

Contacts and locations

Locations

Research Site

Mobile, Alabama, 36604, United States
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Springdale, Arkansas, 72762, United States
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Harbor City, California, 90710, United States
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Solvang, California, 93463, United States
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Lone Tree, Colorado, 80124, United States
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Fort Myers, Florida, 33901-8101, United States
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Jacksonville, Florida, 32256, United States
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West Palm Beach, Florida, 33401, United States
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Indianapolis, Indiana, 46256, United States
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Baton Rouge, Louisiana, 70809, United States
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Silver Spring, Maryland, 20904, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48202, United States
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Hattiesburg, Mississippi, 39401, United States
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Omaha, Nebraska, 68130, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45267, United States
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Portland, Oregon, 97239, United States
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West Columbia, South Carolina, 29169, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78731, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77090, United States
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Tyler, Texas, 75702, United States
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Fairfax, Virginia, 22031, United States
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Kennewick, Washington, 99336, United States
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Renton, Washington, 98055, United States
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Morgantown, West Virginia, 26505, United States
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Feldkirch, 6807, Austria
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Salzburg, 5020, Austria
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Vienna, 1130, Austria
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Anderlecht, 1070, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Sint-Niklaas, 9100, Belgium
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4109, Bulgaria
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Shumen, 9700, Bulgaria
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Sofia, 1330, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1527, Bulgaria
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 1H7, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, H3T 1E2, Canada
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Concepción, 4070196, Chile
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La Serena, 1720430, Chile
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Santiago, 7630370, Chile
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Santiago, 8241479, Chile
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Baoding, 071000, China
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Beijing, 100039, China
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Beijing, 100142, China
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Beijing, China
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Bengbu, 233060, China
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Changchun, 130000, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610042, China
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Chongqing, 400042, China
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Dalian, 116011, China
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Guangzhou, 510060, China
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Guangzhou, 510100, China
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Guiyang, 550004, China
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Haikou, 570311, China
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Hangzhou, 310020, China
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Hangzhou, 310022, China
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Hefei, 230031, China
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Jinan, 250117, China
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Lanzhou, 730000, China
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Linyi, 276000, China
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Nanchang, 330009, China
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Nanjing, 210008, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Tianjin, 300060, China
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Wuhan, 430000, China
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Wuhan, 430022, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Hořovice, 268 01, Czechia
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Hradec Králové, 500 05, Czechia
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Nový Jičín, 741 01, Czechia
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Prague, 100 34, Czechia
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Prague, 140 00, Czechia
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Prague, 150 06, Czechia
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Besançon, 25030, France
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Bordeaux, 33030, France
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Brest, 29609, France
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Caen, 14076, France
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Dijon, 21079, France
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Le Mans, 72000, France
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Lille, 59000, France
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Montpellier, 34070, France
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Pierre-Bénite, 69495, France
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Plerin SUR MER, 22190, France
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Saint-Cloud, 92210, France
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Vandœuvre-lès-Nancy, 54000, France
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Villejuif, 94805, France
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Berlin, 13125, Germany
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Dessau-RoBlau, 06847, Germany
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Essen, 45136, Germany
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Freiburg im Breisgau, 79110, Germany
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Mönchengladbach, 41061, Germany
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München, 81675, Germany
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Münster, 48145, Germany
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Regensburg, 93053, Germany
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Velbert, 42551, Germany
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Budapest, 1062, Hungary
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Budapest, 1088, Hungary
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Budapest, 1122, Hungary
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Győr, 9024, Hungary
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Miskolc, 3526, Hungary
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Nyíregyháza, 4400, Hungary
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Szekszárd, 7100, Hungary
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Zalaegerszeg, 8900, Hungary
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Ahmedabad, 380060, India
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Calicut, 673601, India
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Delhi, 110085, India
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Faridabad, 121001, India
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Gurgaon, 122001, India
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Karamsad, 388325, India
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Kolkata, 700160, India
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Madurai, 625107, India
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Nagpur, 440001, India
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Nashik, 422009, India
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Nashik, 422011, India
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New Delhi, 11029, India
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Bergamo, 24127, Italy
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Florence, 50139, Italy
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Milan, 20141, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Novara, 28100, Italy
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Padova, 35128, Italy
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Parma, 43100, Italy
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Prato, 59100, Italy
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Roma, 00168, Italy
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Roma, 161, Italy
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Rozzano, 20089, Italy
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Chiba, 260-8717, Japan
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Chūōku, 104-0045, Japan
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Chūōku, 862-8655, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Isehara-shi, 259-1193, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kurashiki Shi, 701 0192, Japan
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Kurume-shi, 830-0013, Japan
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Kyoto, 606-8507, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 467-8602, Japan
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Nishinomiya-shi, 663-8501, Japan
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Osaka, 540-0006, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shimotsuke-shi, 329-0498, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 162-8655, Japan
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Suita-shi, 565-0871, Japan
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Takasaki-shi, 370-0829, Japan
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Tsu, 514-8507, Japan
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Tsukuba, 305-8576, Japan
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Yokohama, 241-8515, Japan
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George Town, 10450, Malaysia
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Johor Bahru, 81100, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Kuching, 93586, Malaysia
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Del. Cuauhtemoc, 06700, Mexico
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Estado de México, 50080, Mexico
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La Paz, 23040, Mexico
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Mexico City, 0 3100, Mexico
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Monterrey, 64710, Mexico
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Puebla City, 72424, Mexico
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Drammen, 3004, Norway
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Oslo, N-0379, Norway
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Gdynia, 81-519, Poland
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Konin, 62-500, Poland
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Koszalin, 75-581, Poland
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Lodz, 90-302, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-513, Poland
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Poznan, 60-192, Poland
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Braga, 4710, Portugal
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Guimarães, 4835-044, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1500-650, Portugal
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Lisbon, 1998-018, Portugal
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Loures, 2674-514, Portugal
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Porto, 4099-001, Portugal
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Porto, 4200-319, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Kaluga, 248007, Russia
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Kislino Village, Ryshkovsky Ru, 305524, Russia
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Moscow, 111123, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 121467, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 196603, Russia
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Saint Petersburg, 197758, Russia
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Banská Bystrica, 974 01, Slovakia
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Bratislava, 81250, Slovakia
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Bratislava, 833 01, Slovakia
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Prešov, 081 81, Slovakia
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Trenčín, 91171, Slovakia
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Busan, 49201, South Korea
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Barcelona, 08908, Spain
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Barcelona, 8035, Spain
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Jaén, 23007, Spain
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Lleida, 25198, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Pamplona, 31008, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Valencia, 46015, Spain
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Liestal, CH- 4410, Switzerland
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Zurich, 8008, Switzerland
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, Taiwan
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Taichung, 40443, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10048, Taiwan
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Taipei, 104, Taiwan
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Taipei, 110, Taiwan
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Taipei, 235, Taiwan
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Taoyuan, 333, Taiwan
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Adana, 01120, Turkey (Türkiye)
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06340, Turkey (Türkiye)
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Ankara, 6100, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Izmir, 35620, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Cambridge, CB2 2QQ, United Kingdom
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Colchester, CO4 5JL, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Surrey, GU2 7XX, United Kingdom

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