NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: ER-Positive HER2-Negative Breast Cancer

Interventions: AZD9833, AZD9833 Placebo, Anastrozole, Anastrozole placebo, Letrozole

Countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, France, Germany

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Phoenix, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Long Beach, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Grand Junction, Colorado, United States
Lone Tree, Colorado, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Park Ridge, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Fairhaven, Massachusetts, United States
Foxborough, Massachusetts, United States
Milford, Massachusetts, United States
South Weymouth, Massachusetts, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Oxford, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
+ 234 more on CT.gov