A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
NCT ID: NCT04711252
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
1370 participants
INTERVENTIONAL
2021-01-28
2029-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
INFORMATION FOR TRIAL PARTICIPANTS
In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment.
Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
NCT04214288
Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients
NCT01625286
AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)
NCT01791985
AKT Inhibitor in Oestrogen Positive Breast Cancer
NCT02077569
A Randomized Study of AZD2014 in Combination With Fulvestrant in Metastatic or Advanced Breast Cancer
NCT02216786
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
INFORMATION FOR TRIAL PARTICIPANTS
Researchers are looking for a better way to treat breast cancer.
In people with cancer, some cells have grown out of control to form tumours.
The trial drugs palbociclib, camizestrant, and anastrozole are designed to work by blocking the cancer's ability to grow. Camizestrant is also called AZD9833. Palbociclib and anastrozole are already available as treatments for people with certain type of breast cancer.
In this trial, the researchers want to find out how well taking camizestrant with palbociclib, or anastrozole with palbociclib, works in participants with breast cancer that has ER proteins but does not have overexpression of HER2 protein.
The researchers will look at which trial treatments help the participants live longer with cancer before it gets worse.
The trial will split participants into 2 groups:
* Participants in Group 1 will take camizestrant, palbociclib, and a placebo matched with anastrazole.
* Participants in Group 2 will take anastrozole, palbociclib, , and a placebo matched with camizestrant.
A placebo looks like a treatment but does not have any medicine in it.
A computer program will be used to randomly choose the treatments each participant gets. This helps make sure the groups are chosen fairly. Researchers do this so that comparing the results of each treatment will be as accurate as possible.
The participants will take their trial treatments in periods called "cycles". Each cycle will last 28 days. During each cycle, the participants will take:
* camizestrant or anastrozole once daily by mouth
* palbociclib once daily by mouth for 21 days. Then, they will not take any palbociclib for 7 days
Some participants will also get either goserelin or leuprorelin once every month. Participants could get goserelin or leuprorelin if:
* They are medically determined yet to reach menopause status
* They are male
They will get this treatment as an injection under the skin or into a muscle. Goserelin and leuprorelin work by decreasing the amount of sex hormones made by the body which will lead to reduction of ER production. This can help stop breast cancer from growing.
Participants will take trial treatment until the cancer gets worse or they leave the trial.
Participants will visit their trial site several times throughout the trial. At these visits, the trial doctors will check the health of the participants. They will also take blood samples and do scans of the participants' tumors.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD9833 + palbociclib
The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (1 mg, PO, once daily)
AZD9833
Dosage formulation: AZD9833 tablets will be administered orally
Anastrozole placebo
Dosage formulation: anastrozole placebo tablets will be administrated orally.
Palbociclib
Dosage formulation: palbociclib tablets/capsules will be administered orally
Luteinizing hormone-releasing hormone (LHRH) agonist
Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
Anastrozole + palbociclib
The patients will recieve Anastrozole (1 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)
Anastrozole
Dosage formulation: Anastrozole tablets will be administered orally.
AZD9833 placebo
Dosage formulation: AZD9833 placebo tablets will be administrated orally.
Palbociclib
Dosage formulation: palbociclib tablets/capsules will be administered orally
Luteinizing hormone-releasing hormone (LHRH) agonist
Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD9833
Dosage formulation: AZD9833 tablets will be administered orally
Anastrozole
Dosage formulation: Anastrozole tablets will be administered orally.
Anastrozole placebo
Dosage formulation: anastrozole placebo tablets will be administrated orally.
AZD9833 placebo
Dosage formulation: AZD9833 placebo tablets will be administrated orally.
Palbociclib
Dosage formulation: palbociclib tablets/capsules will be administered orally
Luteinizing hormone-releasing hormone (LHRH) agonist
Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Mobile, Alabama, United States
Research Site
Springdale, Arkansas, United States
Research Site
Harbor City, California, United States
Research Site
Solvang, California, United States
Research Site
Lone Tree, Colorado, United States
Research Site
Fort Myers, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Silver Spring, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Hattiesburg, Mississippi, United States
Research Site
Omaha, Nebraska, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
West Columbia, South Carolina, United States
Research Site
Sioux Falls, South Dakota, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Kennewick, Washington, United States
Research Site
Renton, Washington, United States
Research Site
Morgantown, West Virginia, United States
Research Site
Feldkirch, , Austria
Research Site
Salzburg, , Austria
Research Site
Vienna, , Austria
Research Site
Anderlecht, , Belgium
Research Site
Edegem, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Namur, , Belgium
Research Site
Sint-Niklaas, , Belgium
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Shumen, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, , Canada
Research Site
Concepción, , Chile
Research Site
La Serena, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Baoding, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Changchun, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Dalian, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guiyang, , China
Research Site
Haikou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Jinan, , China
Research Site
Lanzhou, , China
Research Site
Linyi, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Tianjin, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Zhengzhou, , China
Research Site
Hořovice, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Nový Jičín, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Besançon, , France
Research Site
Bordeaux, , France
Research Site
Brest, , France
Research Site
Caen, , France
Research Site
Dijon, , France
Research Site
Le Mans, , France
Research Site
Lille, , France
Research Site
Montpellier, , France
Research Site
Pierre-Bénite, , France
Research Site
Plerin SUR MER, , France
Research Site
Saint-Cloud, , France
Research Site
Vandœuvre-lès-Nancy, , France
Research Site
Villejuif, , France
Research Site
Berlin, , Germany
Research Site
Dessau-RoBlau, , Germany
Research Site
Essen, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Mönchengladbach, , Germany
Research Site
München, , Germany
Research Site
Münster, , Germany
Research Site
Regensburg, , Germany
Research Site
Velbert, , Germany
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Győr, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Szekszárd, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Ahmedabad, , India
Research Site
Calicut, , India
Research Site
Delhi, , India
Research Site
Faridabad, , India
Research Site
Gurgaon, , India
Research Site
Karamsad, , India
Research Site
Kolkata, , India
Research Site
Madurai, , India
Research Site
Nagpur, , India
Research Site
Nashik, , India
Research Site
Nashik, , India
Research Site
New Delhi, , India
Research Site
Bergamo, , Italy
Research Site
Florence, , Italy
Research Site
Milan, , Italy
Research Site
Modena, , Italy
Research Site
Napoli, , Italy
Research Site
Novara, , Italy
Research Site
Padua, , Italy
Research Site
Parma, , Italy
Research Site
Prato, , Italy
Research Site
Roma, , Italy
Research Site
Roma, , Italy
Research Site
Rozzano, , Italy
Research Site
Chiba, , Japan
Research Site
Chūōku, , Japan
Research Site
Chūōku, , Japan
Research Site
Hidaka-shi, , Japan
Research Site
Hirakata-shi, , Japan
Research Site
Isehara-shi, , Japan
Research Site
Kitaadachi-gun, , Japan
Research Site
Kōtoku, , Japan
Research Site
Kumamoto, , Japan
Research Site
Kurashiki Shi, , Japan
Research Site
Kurume-shi, , Japan
Research Site
Kyoto, , Japan
Research Site
Nagoya, , Japan
Research Site
Nagoya, , Japan
Research Site
Nishinomiya-shi, , Japan
Research Site
Osaka, , Japan
Research Site
Osaka, , Japan
Research Site
Ota-shi, , Japan
Research Site
Sapporo, , Japan
Research Site
Sendai, , Japan
Research Site
Shimotsuke-shi, , Japan
Research Site
Shinagawa-ku, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Suita-shi, , Japan
Research Site
Takasaki-shi, , Japan
Research Site
Tsu, , Japan
Research Site
Tsukuba, , Japan
Research Site
Yokohama, , Japan
Research Site
George Town, , Malaysia
Research Site
Johor Bahru, , Malaysia
Research Site
Kuala Lumpur, , Malaysia
Research Site
Kuala Lumpur, , Malaysia
Research Site
Kuala Selangor, , Malaysia
Research Site
Kuching, , Malaysia
Research Site
Del. Cuauhtemoc, , Mexico
Research Site
Estado de México, , Mexico
Research Site
La Paz, , Mexico
Research Site
Mexico City, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Puebla City, , Mexico
Research Site
Drammen, , Norway
Research Site
Oslo, , Norway
Research Site
Gdynia, , Poland
Research Site
Konin, , Poland
Research Site
Koszalin, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Olsztyn, , Poland
Research Site
Poznan, , Poland
Research Site
Braga, , Portugal
Research Site
Guimarães, , Portugal
Research Site
Lisbon, , Portugal
Research Site
Lisbon, , Portugal
Research Site
Lisbon, , Portugal
Research Site
Loures, , Portugal
Research Site
Porto, , Portugal
Research Site
Porto, , Portugal
Research Site
Vila Nova de Gaia, , Portugal
Research Site
Kaluga, , Russia
Research Site
Kislino Village, Ryshkovsky Ru, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Trenčín, , Slovakia
Research Site
Busan, , South Korea
Research Site
Daegu, , South Korea
Research Site
Goyang-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Jaén, , Spain
Research Site
Lleida, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Pamplona, , Spain
Research Site
Santander, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Liestal, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Adana, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Kayseri, , Turkey (Türkiye)
Research Site
Cambridge, , United Kingdom
Research Site
Colchester, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Surrey, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BreastCancerStudyLocator.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-002276-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D8532C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.