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ACTIVE NOT RECRUITING

NCT04964934

PHASE3

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

315

Start Date

2021-06-30

Completion Date

2028-09-01

Last Updated

2026-09-23

Healthy Volunteers

Conditions

ER-Positive HER2-Negative Breast Cancer

Interventions

DRUG

AZD9833

Dosage formulation: AZD9833 tablets will be administered orally

DRUG

AZD9833 Placebo

Dosage formulation: AZD9833 placebo tablets will be administrated orally.

DRUG

Anastrozole

Dosage formulation: anastrozole tablets will be administered orally.

DRUG

Anastrozole placebo

Dosage formulation: anastrozole placebo tablets will be administrated orally.

DRUG

Letrozole

Dosage formulation: letrozole tablets will be administered orally.

DRUG

Letrozole placebo

Dosage formulation: letrozole placebo tablets will be administered orally.

DRUG

Palbociclib

Dosage formulation: palbociclib tablets/capsules will be administered orally

DRUG

Abemaciclib

Dosage formulation: abemaciclib tablets will be administered orally

DRUG

Luteinizing hormone-releasing hormone (LHRH) agonist

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

DRUG

Ribociclib

Dosage formulation: ribociclib tablets will be administered orally

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.

Locations (264)

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Phoenix, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Long Beach, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Grand Junction, Colorado, United States

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Lone Tree, Colorado, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Park Ridge, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Fairhaven, Massachusetts, United States

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Foxborough, Massachusetts, United States

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Milford, Massachusetts, United States

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South Weymouth, Massachusetts, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Rochester, Minnesota, United States

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Oxford, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Camden, New Jersey, United States

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Ridgewood, New Jersey, United States

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Brooklyn, New York, United States

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East Syracuse, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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Shirley, New York, United States

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Goldsboro, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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York, Pennsylvania, United States

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Greenville, South Carolina, United States

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West Columbia, South Carolina, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Bedford, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Midlothian, Virginia, United States

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Norfolk, Virginia, United States

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Tacoma, Washington, United States

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Waukesha, Wisconsin, United States

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Birtinya, Australia

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Darlinghurst, Australia

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Graz, Austria

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Innsbruck, Austria

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Salzburg, Austria

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Vienna, Austria

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Leuven, Belgium

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Liège, Belgium

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Namur, Belgium

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Haskovo, Bulgaria

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Panagyurishte, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Lévis, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Avignon, France

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Brest, France

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Clermont-Ferrand, France

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Dijon, France

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Limoges, France

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Lorient, France

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Lyon, France

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Marseille, France

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Metz-Tessy, France

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Nîmes, France

And 164 more locations on ClinicalTrials.gov

Clinical Research Directory

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (264)