AzTrials
AzTrials

ER-Positive HER2-Negative Breast CancerPhase 3SERENA-4NCT04711252

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

A Phase 3 study testing AZD9833, Anastrozole and Palbociclib in people with ER-Positive HER2-Negative Breast Cancer, run by AstraZeneca at 263 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative)… Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
ER-Positive HER2-Negative Breast Cancer
What is being tested?
AZD9833, Anastrozole and Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,371 participants
Where
263 sitesin 27 countries
Study dates
28 Jan 2021to 1 Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

263 sites in 27 countries.

263 sites in 27 countries

China31 sites

  • Research Site

    Baoding, 071000

  • Research Site

    Beijing, 100039

  • Research Site

    Beijing, 100142

  • Research Site

    Beijing

  • Research Site

    Bengbu, 233004

  • Research Site

    Changchun, 130000

  • Research Site

    Changchun, 130021

  • Research Site

    Changsha, 410013

  • Research Site

    Chengdu, 610042

  • Research Site

    Chongqing, 400042

  • Research Site

    Dalian, 116011

  • Research Site

    Guangzhou, 510060

  • Research Site

    Guangzhou, 510100

  • Research Site

    Guiyang, 550004

  • Research Site

    Haikou, 570311

  • Research Site

    Hangzhou, 310020

  • Research Site

    Hangzhou, 310022

  • Research Site

    Hefei, 230031

  • Research Site

    Jinan, 250117

  • Research Site

    Lanzhou, 730000

  • Research Site

    Linyi, 276000

  • Research Site

    Nanchang, 330009

  • Research Site

    Nanjing, 210008

  • Research Site

    Shanghai, 200025

  • Research Site

    Shanghai, 200032

  • Research Site

    Shenyang, 110001

  • Research Site

    Tianjin, 300060

  • Research Site

    Wuhan, 430000

  • Research Site

    Wuhan, 430040

  • Research Site

    Xi'an, 710061

  • Research Site

    Zhengzhou, 450008

Other trials in China

United States30 sites

  • Research Site

    Austin, Texas, 78731

  • Research Site

    Baton Rouge, Louisiana, 70809

  • Research Site

    Boston, Massachusetts, 02114

  • Research Site

    Chattanooga, Tennessee, 37404

  • Research Site

    Cincinnati, Ohio, 45219

  • Research Site

    Cincinnati, Ohio, 45267

  • Research Site

    Detroit, Michigan, 48202

  • Research Site

    Fairfax, Virginia, 22031

  • Research Site

    Fort Myers, Florida, 33901-8101

  • Research Site

    Harbor City, California, 90710

  • Research Site

    Hattiesburg, Mississippi, 39401

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Houston, Texas, 77090

  • Research Site

    Indianapolis, Indiana, 46256

  • Research Site

    Jacksonville, Florida, 32256

  • Research Site

    Kennewick, Washington, 99336

  • Research Site

    Lone Tree, Colorado, 80124

  • Research Site

    Mobile, Alabama, 36604

  • Research Site

    Morgantown, West Virginia, 26505

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    Omaha, Nebraska, 68130

  • Research Site

    Portland, Oregon, 97239

  • Research Site

    Renton, Washington, 98055

  • Research Site

    Silver Spring, Maryland, 20904

  • Research Site

    Sioux Falls, South Dakota, 57105

  • Research Site

    Solvang, California, 93463

  • Research Site

    Springdale, Arkansas, 72762

  • Research Site

    Tyler, Texas, 75702

  • Research Site

    West Columbia, South Carolina, 29169

  • Research Site

    West Palm Beach, Florida, 33401

Other trials in United States

Japan28 sites

  • Research Site

    Chiba, 260-8717

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Chūōku, 862-8655

  • Research Site

    Hidaka-shi, 350-1298

  • Research Site

    Hirakata-shi, 573-1191

  • Research Site

    Isehara-shi, 259-1193

  • Research Site

    Kitaadachi-gun, 362-0806

  • Research Site

    Kōtoku, 135-8550

  • Research Site

    Kumamoto, 860-8556

  • Research Site

    Kurashiki Shi, 701 0192

  • Research Site

    Kurume-shi, 830-0013

  • Research Site

    Kyoto, 606-8507

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Nagoya, 467-8602

  • Research Site

    Nishinomiya-shi, 663-8501

  • Research Site

    Osaka, 540-0006

  • Research Site

    Osaka, 541-8567

  • Research Site

    Ota-shi, 373-8550

  • Research Site

    Sapporo, 003-0804

  • Research Site

    Sendai, 980-8574

  • Research Site

    Shimotsuke-shi, 329-0498

  • Research Site

    Shinagawa-ku, 142-8666

  • Research Site

    Shinjuku-ku, 162-8655

  • Research Site

    Suita-shi, 565-0871

  • Research Site

    Takasaki-shi, 370-0829

  • Research Site

    Tsu, 514-8507

  • Research Site

    Tsukuba, 305-8576

  • Research Site

    Yokohama, 241-8515

Other trials in Japan

France13 sites

  • Research Site

    Besançon, 25030

  • Research Site

    Bordeaux, 33030

  • Research Site

    Brest, 29609

  • Research Site

    Caen, 14076

  • Research Site

    Dijon, 21079

  • Research Site

    Le Mans, 72000

  • Research Site

    Lille, 59000

  • Research Site

    Montpellier, 34070

  • Research Site

    Pierre-Bénite, 69495

  • Research Site

    Plerin SUR MER, 22190

  • Research Site

    Saint-Cloud, 92210

  • Research Site

    Vandœuvre-lès-Nancy, 54000

  • Research Site

    Villejuif, 94805

Other trials in France

India12 sites

  • Research Site

    Ahmedabad, 380060

  • Research Site

    Calicut, 673601

  • Research Site

    Delhi, 110085

  • Research Site

    Faridabad, 121001

  • Research Site

    Gūrgaon, 122001

  • Research Site

    Karamsad, 388325

  • Research Site

    Kolkata, 700160

  • Research Site

    Madurai, 625107

  • Research Site

    Nagpur, 440001

  • Research Site

    Nashik, 422009

  • Research Site

    Nashik, 422011

  • Research Site

    New Delhi, 110029

Other trials in India

Italy12 sites

  • Research Site

    Bergamo, 24127

  • Research Site

    Florence, 50139

  • Research Site

    Milan, 20141

  • Research Site

    Modena, 41124

  • Research Site

    Naples, 80131

  • Research Site

    Novara, 28100

  • Research Site

    Padova, 35128

  • Research Site

    Parma, 43100

  • Research Site

    Prato, 59100

  • Research Site

    Roma, 00168

  • Research Site

    Roma, 161

  • Research Site

    Rozzano, 20089

Other trials in Italy

Spain11 sites

  • Research Site

    Barcelona, 08908

  • Research Site

    Barcelona, 8035

  • Research Site

    Jaén, 23007

  • Research Site

    Lleida, 25198

  • Research Site

    Madrid, 28040

  • Research Site

    Madrid, 28046

  • Research Site

    Málaga, 29010

  • Research Site

    Pamplona, 31005

  • Research Site

    Santander, 39008

  • Research Site

    Seville, 41013

  • Research Site

    Valencia, 46015

Other trials in Spain

Russia10 sites

  • Research Site

    Kaluga, 248007

  • Research Site

    Kislino Village, Ryshkovsky Ru, 305524

  • Research Site

    Moscow, 111123

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 117997

  • Research Site

    Moscow, 121467

  • Research Site

    Saint Petersburg, 190103

  • Research Site

    Saint Petersburg, 195067

  • Research Site

    Saint Petersburg, 196603

  • Research Site

    Saint Petersburg, 197758

Other trials in Russia

Germany9 sites

  • Research Site

    Berlin, 13125

  • Research Site

    Dessau-RoBlau, 06847

  • Research Site

    Essen, 45136

  • Research Site

    Freiburg im Breisgau, 79110

  • Research Site

    Mönchengladbach, 41061

  • Research Site

    München, 81675

  • Research Site

    Münster, 48145

  • Research Site

    Regensburg, 93053

  • Research Site

    Velbert, 42551

Other trials in Germany

Portugal9 sites

  • Research Site

    Braga, 4710

  • Research Site

    Guimarães, 4835-044

  • Research Site

    Lisbon, 1400-038

  • Research Site

    Lisbon, 1500-650

  • Research Site

    Lisbon, 1998-018

  • Research Site

    Loures, 2674-514

  • Research Site

    Porto, 4099-001

  • Research Site

    Porto, 4200-319

  • Research Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Taiwan9 sites

  • Research Site

    Kaohsiung City, 82445

  • Research Site

    Kaohsiung City

  • Research Site

    Taichung, 40443

  • Research Site

    Tainan, 70403

  • Research Site

    Taipei, 10048

  • Research Site

    Taipei, 104

  • Research Site

    Taipei, 110

  • Research Site

    Taipei, 235

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

Hungary8 sites

  • Research Site

    Budapest, 1062

  • Research Site

    Budapest, 1088

  • Research Site

    Budapest, 1122

  • Research Site

    Győr, 9024

  • Research Site

    Miskolc, 3526

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Szekszárd, 7100

  • Research Site

    Zalaegerszeg, 8900

Other trials in Hungary

South Korea8 sites

  • Research Site

    Busan, 49201

  • Research Site

    Daegu, 41404

  • Research Site

    Goyang-si, 10408

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06273

  • Research Site

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)8 sites

  • Research Site

    Adana, 01120

  • Research Site

    Ankara, 06010

  • Research Site

    Ankara, 06230

  • Research Site

    Ankara, 06340

  • Research Site

    Ankara, 6100

  • Research Site

    Izmir, 35100

  • Research Site

    Izmir, 35620

  • Research Site

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Belgium7 sites

  • Research Site

    Anderlecht, 1070

  • Research Site

    Edegem, 2650

  • Research Site

    Ghent, 9000

  • Research Site

    Leuven, 3000

  • Research Site

    Liège, 4000

  • Research Site

    Namur, 5000

  • Research Site

    Sint-Niklaas, 9100

Other trials in Belgium

Poland7 sites

  • Research Site

    Gdynia, 81-519

  • Research Site

    Konin, 62-500

  • Research Site

    Koszalin, 75-581

  • Research Site

    Lodz, 90-302

  • Research Site

    Lublin, 20-090

  • Research Site

    Olsztyn, 10-513

  • Research Site

    Poznan, 60-192

Other trials in Poland

Bulgaria6 sites

  • Research Site

    Plovdiv, 4000

  • Research Site

    Plovdiv, 4109

  • Research Site

    Shumen, 9700

  • Research Site

    Sofia, 1330

  • Research Site

    Sofia, 1431

  • Research Site

    Sofia, 1527

Other trials in Bulgaria

Canada6 sites

  • Research Site

    Edmonton, Alberta, T6G 1Z2

  • Research Site

    Kitchener, Ontario, N2G 1G3

  • Research Site

    London, Ontario, N6A 5W9

  • Research Site

    Montreal, H3T 1E2

  • Research Site

    Toronto, Ontario, M5G 2M9

  • Research Site

    Vancouver, British Columbia, V5Z 1H7

Other trials in Canada

Czechia6 sites

  • Research Site

    Hořovice, 268 01

  • Research Site

    Hradec Králové, 500 05

  • Research Site

    Nový Jičín, 741 01

  • Research Site

    Prague, 100 34

  • Research Site

    Prague, 140 00

  • Research Site

    Prague, 150 06

Other trials in Czechia

Malaysia6 sites

  • Research Site

    George Town, 10450

  • Research Site

    Johor Bahru, 81100

  • Research Site

    Kuala Lumpur, 50586

  • Research Site

    Kuala Lumpur, 59100

  • Research Site

    Kuala Selangor, 62250

  • Research Site

    Kuching, 93586

Other trials in Malaysia

Mexico6 sites

  • Research Site

    Del. Cuauhtemoc, 06700

  • Research Site

    La Paz, 23040

  • Research Site

    Mexico City, 0 3100

  • Research Site

    Monterrey, 64710

  • Research Site

    Puebla City, 72424

  • Research Site

    Toluca, 50120

Other trials in Mexico

Slovakia5 sites

  • Research Site

    Banská Bystrica, 974 01

  • Research Site

    Bratislava, 81250

  • Research Site

    Bratislava, 833 01

  • Research Site

    Prešov, 081 81

  • Research Site

    Trenčín, 91171

Other trials in Slovakia

United Kingdom5 sites

  • Research Site

    Cambridge, CB2 2QQ

  • Research Site

    Colchester, CO4 5JL

  • Research Site

    Leeds, LS9 7TF

  • Research Site

    Nottingham, NG5 1PB

  • Research Site

    Surrey, GU2 7XX

Other trials in United Kingdom

Chile4 sites

  • Research Site

    Concepción, 4070196

  • Research Site

    La Serena, 1720430

  • Research Site

    Santiago, 7630370

  • Research Site

    Santiago, 8241479

Other trials in Chile

Austria3 sites

  • Research Site

    Feldkirch, 6807

  • Research Site

    Salzburg, 5020

  • Research Site

    Vienna, 1130

Other trials in Austria

Norway2 sites

  • Research Site

    Drammen, 3004

  • Research Site

    Oslo, N-0379

Other trials in Norway

Switzerland2 sites

  • Research Site

    Liestal, CH- 4410

  • Research Site

    Zurich, 8008

Other trials in Switzerland

About this study

Official title: SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer.

INFORMATION FOR TRIAL PARTICIPANTS

Read more

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.

Read the detailed description

A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with palbociclib versus anastrozole in combination with palbociclib for the treatment of patients with ER-positive breast cancer. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole in the context of combination with palbociclib in first line setting.

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.

Being tested
AZD9833, Anastrozole, Anastrozole placebo, AZD9833 placebo, Palbociclib
Keywords
Metastatic, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases, Hormones, Hormone Substitutes, and Hormone, Physiological Effects of Drugs, Randomised, Multicentre, Double-Blind, Phase III, AZD9833, Next Generation Oral SERD, Anastrozole, Palbociclib, Antagonists, Antineoplastic Agents, Estrogen Receptor Antagonists, Hormone Antagonists
Medical subject headings
Neoplasm Metastasis, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD9833Drug

    Dosage formulation: AZD9833 tablets will be administered orally

  • AnastrozoleDrug

    Dosage formulation: Anastrozole tablets will be administered orally.

  • Anastrozole placeboDrug

    Dosage formulation: anastrozole placebo tablets will be administrated orally.

  • AZD9833 placeboDrug

    Dosage formulation: AZD9833 placebo tablets will be administrated orally.

  • PalbociclibDrug

    Dosage formulation: palbociclib tablets/capsules will be administered orally

  • Luteinizing hormone-releasing hormone (LHRH) agonistDrug

    Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.

Study groups in NCT04711252
Study groupRoleWhat they receive
AZD9833 + palbociclibExperimentalThe 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)
Receives: Drug: AZD9833; Drug: Anastrozole placebo; Drug: Palbociclib; Drug: Luteinizing hormone-releasing hormone (LHRH) agonist
Anastrozole + palbociclibActive comparatorThe 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)
Receives: Drug: Anastrozole; Drug: AZD9833 placebo; Drug: Palbociclib; Drug: Luteinizing hormone-releasing hormone (LHRH) agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1

    PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death.

    Measured: From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)

Secondary outcomes (11)

  1. Overall survival (OS)

    The OS is defined as the time from randomization to death due to any cause.

    Measured: From randomization until the date of death due to any cause (up to 8 years)

  2. Second progression-free survival (PFS2)

    Time to second progression or death (PFS2) will be defined as the time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.

    Measured: From randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (up to 5 years)

  3. Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1

    ORR is defined as the proportion of patients who have a CR or partial response, as determined by the investigator at local site per RECIST 1.1.

    Measured: From randomization until a response or in the absence of a response from randomization up until progression, or the last evaluable assessment in the absence of progression (up to 5 years)

  4. Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1

    The DoR will be defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.

    Measured: From the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)

  5. Time to chemotherapy (TTC)

    Time to chemotherapy is defined as the time from randomization until the earlier of the start date of chemotherapy or death due to any cause.

    Measured: From randomization until the earlier of the start date of chemotherapy or death due to any cause (up to 5 years)

  6. Time to first subsequent anti-cancer therapy (TFST)

    TFST is defined as time from randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.

    Measured: From randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause (up to 5 years)

  7. Clinical benefit rate at 24 weeks (CBR24)

    CBR at 24 weeks is defined as the percentage of participants who have a complete response (CR) or partial response or who have stable disease (SD) per RECIST 1.1 as assessed by the investigator at local site for at least 23 weeks after randomization (to allow for an early assessment within the assessment window).

    Measured: At least 23 weeks after randomisation

  8. Time to second subsequent therapy (TSST)

    TSST is defined as time from randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.

    Measured: From randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (up to 5 years)

  9. Plasma concentration of AZD9833 at specified timepoints

    To assess the steady state PK of AZD9833 in combination with palbociclib in all participants who receive at least one dose of AZD9833 per the protocol, for whom there are at least one reportable PK concentration.

    Measured: on Day 15

  10. Change from baseline in EORTC QLQ-C30 scale scores

    Change from baseline in EORTC QLQ-C30 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score.

    Measured: From baseline to 24 weeks post progression (up to approximately 5 years)

  11. Change from baseline in EORTC QLQ-BR45 scale scores

    Change from baseline in EORTC QLQ-BR45 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score.

    Measured: From baseline to 24 weeks post progression (up to approximately 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start28 Jan 2021
  3. Primary completion26 Jun 2026
  4. Study completion1 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,371 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04711252
Sponsor's protocol ID
D8532C00001
Other IDs
2020-002276-12
Acronym
SERENA-4
Status last verified
Sep 2026
First submitted
23 Dec 2020
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD9833, Anastrozole and Palbociclib in people with ER-Positive HER2-Negative Breast Cancer, run by AstraZeneca at 263 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 263 sites in China, United States, Japan, France, India and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 (time frame: From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04711252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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