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NCT07647328PHASE3Recruiting

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

AstraZeneca

Start Date

6/15/2026

Completion Date

2/28/2029

Summary

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.

Detailed Description

This global, multicenter, Phase IIIb, single-arm study will evaluate the efficacy, safety, and tolerability of camizestrant combined with ribociclib in patients with ER+ HER2- advanced breast cancer who have not previously received systemic therapy for advanced disease. 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.

Eligibility Criteria

Age Range: 18 years to 130 years

Inclusion Criteria: 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. Exclusion Criteria: 1. Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib. 2. No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging. 3. Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis. 4. Persistent treatment-induced non-haematological toxicities (CTCAE Grade \> 2). 5. Known active infection including tuberculosis HBV and HCV. 6. Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines. 7. Any clinically important abnormalities in heart conduction patterns; participants with pacemakers or medically controlled atrial fibrillation are not excluded. 8. Ongoing symptomatic hypotension. 9. Pregnant or lactating women or patients not willing to use highly effective contraception as defined in the protocol.

Interventions

DRUG

Camizestrant

DRUG

Ribociclib

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Conditions

ER-Positive HER2-Negative Breast Cancer

Locations

Research Site

Duarte, California 91010

United States

Research Site

Palo Alto, California 94304

United States

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Marietta, Georgia 30060

United States

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Evanston, Illinois 60201

United States

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Edgewood, Kentucky 41017

United States

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Louisville, Kentucky 40202

United States

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Reno, Nevada 89502

United States

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Sioux Falls, South Dakota 57105

United States

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Nashville, Tennessee 37204

United States

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Fort Worth, Texas 76104

United States

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Kingwood, Texas 77339

United States

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Midlothian, Virginia 23114

United States

Research Site

Angers, 49933

France

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Bayonne, 64109

France

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Bobigny, 93000

France

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Caen, 14000

France

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Chambray-lès-Tours, 37170

France

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Grenoble, 38043

France

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Montpellier, 34070

France

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Nancy, 54100

France

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Nîmes, 30029

France

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Paris, 75014

France

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Pierre-Bénite, 69310

France

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Valenciennes, 59300

France

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Vandœuvre-lès-Nancy, 54519

France

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Villejuif, 94805

France

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Berlin, 13125

Germany

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Düsseldorf, 40235

Germany

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Freiburg im Breisgau, 79110

Germany

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Mönchengladbach, 41061

Germany

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München, 81675

Germany

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Paderborn, 33098

Germany

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Trier, 54290

Germany

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Velbert, 42551

Germany

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Aviano, 33081

Italy

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Bergamo, 24127

Italy

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Genova, 16132

Italy

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Milan, 20127

Italy

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Naples, 80131

Italy

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Gdansk, 80-952

Poland

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Konin, 62-500

Poland

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Krakow, 30-688

Poland

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Lodz, 90-302

Poland

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Lublin, 20-090

Poland

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Poznan, 61-485

Poland

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Przemyśl, 37-700

Poland

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Wroclaw, 53-413

Poland

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Cheonan-si, 31151

South Korea

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Daegu, 42415

South Korea

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Goyang-si, 10408

South Korea

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Hwasun-eup, 58128

South Korea

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Incheon, 405-760

South Korea

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Seongbuk-Gu, 02841

South Korea

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Seongnam-si, 13520

South Korea

Research Site

Seongnam-si, 13620

South Korea

Research Site

Seoul, 03080

South Korea

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Seoul, 06273

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

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Seoul, 07985

South Korea

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Seoul, 3722

South Korea

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Songpa-gu, 05505

South Korea

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Suwon, 16499

South Korea

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Badajoz, 06080

Spain

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Badalona, 08916

Spain

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Barcelona, 08041

Spain

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Burgos, 9006

Spain

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Donostia / San Sebastian, 20014

Spain

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Huelva, 21005

Spain

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Jaén, 23007

Spain

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Las Palmas de Gran Canaria, 35016

Spain

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Majadahonda, 28222

Spain

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Málaga, 29010

Spain

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Murcia, 30008

Spain

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Oviedo, 33011

Spain

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Palma de Mallorca, 07198

Spain

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Pontevedra, 36312

Spain

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Pozuelo de Alarcón, 28223

Spain

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Santander, 39008

Spain

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Toledo, 45007

Spain

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Zaragoza, 50009

Spain

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Basel, 4031

Switzerland

Research Site

Liestal, CH-4410

Switzerland

Research Site

Rennaz, 1847

Switzerland