Active, not recruiting
Phase 3
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Condition(s) studied
ER-Positive HER2-Negative Breast Cancer
Investigational drug(s) / intervention(s)
AZD9833AZD9833 PlaceboAnastrozoleAnastrozole placeboLetrozoleLetrozole placeboPalbociclibAbemaciclibLuteinizing hormone-releasing hormone (LHRH) agonistRibociclib
AZD9833: Dosage formulation: AZD9833 tablets will be administered orally
AZD9833 Placebo: Dosage formulation: AZD9833 placebo tablets will be administrated orally.
Anastrozole: Dosage formulation: anastrozole tablets will be administered orally.
Anastrozole placebo: Dosage formulation: anastrozole placebo tablets will be administrated orally.
Letrozole: Dosage formulation: letrozole tablets will be administered orally.
Letrozole placebo: Dosage formulation: letrozole placebo tablets will be administered orally.
Palbociclib: Dosage formulation: palbociclib tablets/capsules will be administered orally
Abemaciclib: Dosage formulation: abemaciclib tablets 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.
Ribociclib: Dosage formulation: ribociclib tablets will be administered orally
Study summary
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
Eligibility
INCLUSION CRITERIA:
INFORMATION FOR TRIAL PARTICIPANTS - Participants can join the trial if they:
* Have advanced breast cancer that is not able to be treated with surgery or radiation;
* Have an ESR1 mutation in their cancer;
* Have breast cancer that is HR-positive and HER2-negative;
* Are currently being treated with a CDK4/6 inhibitor and an AI and have been taking these drugs for at least 6 months;
* Have not had their cancer get worse after taking an AI and CDK4/6 inhibitor;
* Are able to do their daily activities;
* Are at least 18.
Full list of inclusion criteria:
* Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent;
* Documentation of histologically confirmed diagnosis of estrogen receptor positive (ER+) /HER2- breast cancer based on local laboratory results;
* Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) ± LHRH as the initial endocrine based treatment for advanced disease;
* Eastern Cooperative Oncology Group performance status of 0 or 1;
* ESR1m detected by central testing of ctDNA with Guardant360® CDx;
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
* Adequate organ and marrow function.
EXCLUSION CRITERIA:
INFORMATION FOR TRIAL PARTICIPANTS - Participants cannot join the trial if they:
* Had certain types of tumors in the past that may come back;
* Are currently taking any other treatments for their cancer or other conditions including hormone replacements, medications, or supplements that could interfere with the trial treatment;
* Have or have had any major health problem, infection, or recent surgery that could make it difficult or dangerous to participate in this trial.
Full list of exclusion criteria:
* Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term;
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease;
* Any evidence of severe or uncontrolled systemic 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;
* Patient with known or family history of severe heart disease;
* Previous treatment with AZD9833, investigational SERDs or fulvestrant;
* Currently pregnant (confirmed with positive pregnancy test) or breastfeeding;
* Persistent non-haematological toxicities (CTCAE Grade \> 2) caused by CDK4/6 inhibitor and/or AI treatment.
Primary outcome measure(s)
- Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1) — From randomization until the earlier of the progression event or death (approximately 2 years)
PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST 1.1) or death.
Trial sites (264)
| Facility | City | Region | Status |
| Research Site |
Phoenix |
Arizona |
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| Research Site |
Hot Springs |
Arkansas |
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| Research Site |
Little Rock |
Arkansas |
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| Research Site |
Long Beach |
California |
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| Research Site |
San Diego |
California |
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| Research Site |
Santa Rosa |
California |
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| Research Site |
Grand Junction |
Colorado |
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| Research Site |
Lone Tree |
Colorado |
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| Research Site |
Fort Myers |
Florida |
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| Research Site |
Jacksonville |
Florida |
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| Research Site |
Jacksonville |
Florida |
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| Research Site |
St. Petersburg |
Florida |
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| Research Site |
Atlanta |
Georgia |
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| Research Site |
Atlanta |
Georgia |
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| Research Site |
Atlanta |
Georgia |
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| Research Site |
Park Ridge |
Illinois |
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| Research Site |
Fort Wayne |
Indiana |
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| Research Site |
Indianapolis |
Indiana |
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| Research Site |
Baltimore |
Maryland |
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| Research Site |
Boston |
Massachusetts |
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| Research Site |
Fairhaven |
Massachusetts |
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| Research Site |
Foxborough |
Massachusetts |
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| Research Site |
Milford |
Massachusetts |
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| Research Site |
South Weymouth |
Massachusetts |
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| Research Site |
Detroit |
Michigan |
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| Research Site |
Grand Rapids |
Michigan |
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| Research Site |
Rochester |
Minnesota |
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| Research Site |
Oxford |
Mississippi |
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| Research Site |
Kansas City |
Missouri |
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| Research Site |
St Louis |
Missouri |
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| Research Site |
Billings |
Montana |
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| Research Site |
Omaha |
Nebraska |
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| Research Site |
Camden |
New Jersey |
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| Research Site |
Ridgewood |
New Jersey |
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| Research Site |
Brooklyn |
New York |
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| Research Site |
East Syracuse |
New York |
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| Research Site |
New Hyde Park |
New York |
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| Research Site |
New York |
New York |
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| Research Site |
New York |
New York |
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| Research Site |
Shirley |
New York |
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+ 224 more sites — see the full list on the official registry below.