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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: ER-Positive HER2-Negative Breast Cancer

In brief

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 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.

Key facts

Study ID: NCT04711252
Run by: AstraZeneca
People needed: 1370
Starts: 2021-01-28
Expected to finish: 2029-02-01
Last updated by the study team: 2025-10-14

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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

You may not qualify if…

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.
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.

Where it is running

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 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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