A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer (NCT07647328)

🧪 Interventions in This Study

• Camizestrant (DRUG)
• Ribociclib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Capable of giving signed informed consent.
2. Female or male, must be ≥ 18 years or as per locally allowed age limit for screening. Type of Participant and Disease Characteristics
3. Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent.
4. Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
5. De novo Stage 4 disease, or recurrence from early CD stage breast cancer after having received 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.
6. ECOG performance status of 0 or 1.
7. Adequate organ and marrow function. Sex and Contraceptive/Barrier Requirements
8. For those female or male patients who are not abstinent (in line with their preferred and usual lifestyle choice), and intend to be heterosexually active with a partner: Female patients must be using highly effective contraceptive measures from the time of screening until 4 weeks after discontinuation of study treatment, and must have a negative serum pregnancy test before first dose of any study treatment if they are of childbearing potential; or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening: (a) Post-menopausal, defined as women with cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause: (i) Age ≥ 60 years (ii) Age \< 60 years with serum estradiol and FSH level within the laboratory's reference range for post-menopausal females (iii) Previous bilateral surgical oophorectomy (iv) Medically confirmed ovarian failure OR (b) Pre/peri-menopausal, ie, not meeting the criteria for being post-menopausal. (i) Pre-/peri-menopausal women can be enrolled if amenable to be treated with monthly LHRH agonists (goserelin or leuprorelin \[also known as leuprolide\]). Patients must have concomitant treatment with LHRH agonists (goserelin or leuprorelin \[leuprolide\]) before or on the same day as the first dose of study treatment - and must be willing to continue on it for the duration of the study. Non sterilised male partners of a patient who is a woman of childbearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) throughout this period. Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening throughout the total duration of the programme and the drug washout period to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Male patients can be enrolled if amenable to be treated with monthly LHRH agonists (goserelin or leuprorelin \[also known as leuprolide\]) unless the patients have clear orchiectomy medical history. Willingness to use 2 non-hormonal based methods of contraception throughout the study.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (89 Sites)

Showing the first 25 of 89 sites.

• Research Site — Duarte, California
• Research Site — Palo Alto, California
• Research Site — Marietta, Georgia
• Research Site — Evanston, Illinois
• Research Site — Edgewood, Kentucky
• Research Site — Louisville, Kentucky
• Research Site — Reno, Nevada
• Research Site — Sioux Falls, South Dakota
• Research Site — Nashville, Tennessee
• Research Site — Fort Worth, Texas
• Research Site — Kingwood, Texas
• Research Site — Midlothian, Virginia
• Research Site — Angers,
• Research Site — Bayonne,
• Research Site — Bobigny,
• Research Site — Caen,
• Research Site — Chambray-lès-Tours,
• Research Site — Grenoble,
• Research Site — Montpellier,
• Research Site — Nancy,
• Research Site — Nîmes,
• Research Site — Paris,
• Research Site — Pierre-Bénite,
• Research Site — Valenciennes,
• Research Site — Vandœuvre-lès-Nancy,

📞 Contact the Study Coordinator

Phone: (877) 240-9479

Email: information.center@astrazeneca.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Approximately 150 participants will be enrolled, and all enrolled participants will receive standard daily oral doses of camizestrant 75 mg and ribociclib 600 mg until treatment discontinuation.

More studies in ER-Positive HER2-Negative Breast Cancer

• 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 — Mobile, Alabama
• Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) — Phoenix, Arizona

Explore by condition: All ER-Positive HER2-Negative Breast Cancer clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.