What is camizestrant studying for ER-positive, HER2-negative advanced breast cancer?

Camizestrant is being studied in combination with ribociclib to evaluate its effectiveness, safety, and tolerability as a first-line treatment for advanced ER-positive, HER2-negative breast cancer. This research aims to understand how well this combination works and its impact on patients with this condition.

Who may be eligible for this ER-positive, HER2-negative advanced breast cancer clinical trial?

Adults 18 years and older diagnosed with ER-positive, HER2-negative advanced breast cancer who have not received prior systemic therapy for advanced disease may be eligible. Participants should have good health status and agree to use contraception if sexually active. Please review eligibility criteria for more details.

Is there any cost to participate in this ER-positive, HER2-negative advanced breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years - 130Years

All Genders

ID07647328

Evaluation of Camizestrant and Ribociclib Combination for First-Line Treatment of ER-Positive, HER2-Negative Advanced Breast Cancer

Led by AstraZeneca · Updated on 2026-08-10

150

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

CONDITIONS

Brief Title

A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer

Who Can Participate

Age: 18Years - 130Years

All Genders

Eligibility Criteria

You may qualify if you...

Able to provide signed informed consent
Male or female aged 18 years or older
Diagnosed with ER-positive, HER2-negative breast cancer not suitable for curative surgery or radiation
No prior systemic anti-cancer therapy for advanced or recurrent ER-positive disease
Either de novo stage 4 disease or recurrence after standard adjuvant endocrine therapy with at least 12 months since last adjuvant AI therapy without progression
ECOG performance status 0 or 1
Adequate organ and bone marrow function
Women of childbearing potential must use highly effective contraception and have a negative pregnancy test before starting treatment or be confirmed non-childbearing
Pre/peri-menopausal women must be willing to use monthly LHRH agonists during the study
Male participants who are sexually active with female partners of childbearing potential must be surgically sterile or use effective contraception and agree not to donate sperm during the study

You will not qualify if you...

Not indicated for endocrine therapy combined with ribociclib
No evidence of advanced inoperable disease or only bone disease with sclerotic/osteoblastic lesions
Advanced, symptomatic visceral disease with risk of life-threatening complications or pulmonary lymphangitis
Persistent non-blood toxicities of grade greater than 2 from prior treatments
Active infections including tuberculosis, hepatitis B or C
Known HIV positive status (except if meeting FDA and ASCO guidelines)
Clinically significant heart conduction abnormalities; pacemakers or controlled atrial fibrillation allowed
Ongoing symptomatic low blood pressure
Pregnant or breastfeeding women or those unwilling to use effective contraception as defined

Research Team

AstraZeneca Clinical Study Information Center

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Evaluation of Camizestrant and Ribociclib Combination for First-Line Treatment of ER-Positive, HER2-Negative Advanced Breast Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria