New pill combo aims to delay chemo in advanced breast cancer
NCT ID NCT07647328
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 5 times
Summary
This phase 3 trial is testing two oral drugs, camizestrant and ribociclib, as a first treatment for people with ER-positive, HER2-negative advanced breast cancer. The goal is to see if the combination can delay the need for next cancer therapy. About 150 participants will take the pills daily until their cancer progresses or side effects become too much.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camizestrant and ribociclib (oral tablets)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option that delays the need for further chemotherapy in advanced breast cancer.
- What could go wrong
- This is a single-arm, open-label study without a placebo group, so results may be less definitive. Side effects from the drug combination are possible, and the trial is still recruiting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
89 sites in 9 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
NOT_YET_RECRUITINGDuarte, California, 91010, United States
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Research Site
NOT_YET_RECRUITINGPalo Alto, California, 94304, United States
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Research Site
RECRUITINGMarietta, Georgia, 30060, United States
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Research Site
NOT_YET_RECRUITINGEvanston, Illinois, 60201, United States
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Research Site
NOT_YET_RECRUITINGEdgewood, Kentucky, 41017, United States
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Research Site
NOT_YET_RECRUITINGLouisville, Kentucky, 40202, United States
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Research Site
NOT_YET_RECRUITINGReno, Nevada, 89502, United States
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Research Site
NOT_YET_RECRUITINGSioux Falls, South Dakota, 57105, United States
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Research Site
NOT_YET_RECRUITINGNashville, Tennessee, 37204, United States
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Research Site
NOT_YET_RECRUITINGFort Worth, Texas, 76104, United States
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Research Site
RECRUITINGKingwood, Texas, 77339, United States
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Research Site
NOT_YET_RECRUITINGMidlothian, Virginia, 23114, United States
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Research Site
NOT_YET_RECRUITINGAngers, 49933, France
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Research Site
NOT_YET_RECRUITINGBayonne, 64109, France
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Research Site
NOT_YET_RECRUITINGBobigny, 93000, France
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Research Site
NOT_YET_RECRUITINGCaen, 14000, France
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Research Site
NOT_YET_RECRUITINGChambray-lès-Tours, 37170, France
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Research Site
NOT_YET_RECRUITINGGrenoble, 38043, France
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Research Site
NOT_YET_RECRUITINGMontpellier, 34070, France
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Research Site
NOT_YET_RECRUITINGNancy, 54100, France
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Research Site
NOT_YET_RECRUITINGNîmes, 30029, France
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Research Site
NOT_YET_RECRUITINGParis, 75014, France
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Research Site
NOT_YET_RECRUITINGPierre-Bénite, 69310, France
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Research Site
NOT_YET_RECRUITINGValenciennes, 59300, France
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Research Site
NOT_YET_RECRUITINGVandœuvre-lès-Nancy, 54519, France
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Research Site
NOT_YET_RECRUITINGVillejuif, 94805, France
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Research Site
NOT_YET_RECRUITINGBerlin, 13125, Germany
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Research Site
NOT_YET_RECRUITINGDüsseldorf, 40235, Germany
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NOT_YET_RECRUITINGErlangen, 91054, Germany
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NOT_YET_RECRUITINGFreiburg im Breisgau, 79110, Germany
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Research Site
NOT_YET_RECRUITINGMönchengladbach, 41061, Germany
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NOT_YET_RECRUITINGMünchen, 81675, Germany
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Research Site
NOT_YET_RECRUITINGPaderborn, 33098, Germany
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Research Site
NOT_YET_RECRUITINGTrier, 54290, Germany
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Research Site
NOT_YET_RECRUITINGVelbert, 42551, Germany
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Research Site
NOT_YET_RECRUITINGAviano, 33081, Italy
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Research Site
NOT_YET_RECRUITINGBergamo, 24127, Italy
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Research Site
NOT_YET_RECRUITINGGenova, 16132, Italy
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Research Site
NOT_YET_RECRUITINGMilan, 20127, Italy
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NOT_YET_RECRUITINGNaples, 80131, Italy
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NOT_YET_RECRUITINGGdansk, 80-952, Poland
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Research Site
NOT_YET_RECRUITINGKonin, 62-500, Poland
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Research Site
NOT_YET_RECRUITINGKrakow, 30-688, Poland
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Research Site
NOT_YET_RECRUITINGLodz, 90-302, Poland
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Research Site
NOT_YET_RECRUITINGLublin, 20-090, Poland
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Research Site
NOT_YET_RECRUITINGPoznan, 61-485, Poland
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Research Site
SUSPENDEDPrzemyśl, 37-700, Poland
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Research Site
NOT_YET_RECRUITINGWroclaw, 53-413, Poland
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Research Site
NOT_YET_RECRUITINGCheonan-si, 31151, South Korea
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Research Site
SUSPENDEDDaegu, 42415, South Korea
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Research Site
NOT_YET_RECRUITINGGoyang-si, 10408, South Korea
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Research Site
NOT_YET_RECRUITINGHwasun-eup, 58128, South Korea
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Research Site
NOT_YET_RECRUITINGIncheon, 405-760, South Korea
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Research Site
NOT_YET_RECRUITINGSeongbuk-Gu, 02841, South Korea
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Research Site
NOT_YET_RECRUITINGSeongnam-si, 13520, South Korea
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Research Site
NOT_YET_RECRUITINGSeongnam-si, 13620, South Korea
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Research Site
NOT_YET_RECRUITINGSeoul, 03080, South Korea
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Research Site
NOT_YET_RECRUITINGSeoul, 06273, South Korea
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Research Site
NOT_YET_RECRUITINGSeoul, 06351, South Korea
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Research Site
NOT_YET_RECRUITINGSeoul, 06591, South Korea
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Research Site
NOT_YET_RECRUITINGSeoul, 07985, South Korea
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Research Site
NOT_YET_RECRUITINGSeoul, 3722, South Korea
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Research Site
NOT_YET_RECRUITINGSongpa-gu, 05505, South Korea
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Research Site
SUSPENDEDSuwon, 16499, South Korea
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Research Site
NOT_YET_RECRUITINGBadajoz, 06080, Spain
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Research Site
NOT_YET_RECRUITINGBadalona, 08916, Spain
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Research Site
NOT_YET_RECRUITINGBarcelona, 08041, Spain
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Research Site
NOT_YET_RECRUITINGBurgos, 9006, Spain
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Research Site
NOT_YET_RECRUITINGDonostia / San Sebastian, 20014, Spain
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Research Site
NOT_YET_RECRUITINGHuelva, 21005, Spain
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Research Site
NOT_YET_RECRUITINGJaén, 23007, Spain
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Research Site
NOT_YET_RECRUITINGLas Palmas de Gran Canaria, 35016, Spain
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Research Site
NOT_YET_RECRUITINGMajadahonda, 28222, Spain
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Research Site
NOT_YET_RECRUITINGMálaga, 29010, Spain
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Research Site
NOT_YET_RECRUITINGMurcia, 30008, Spain
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Research Site
NOT_YET_RECRUITINGOviedo, 33011, Spain
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Research Site
NOT_YET_RECRUITINGPalma de Mallorca, 07198, Spain
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Research Site
NOT_YET_RECRUITINGPontevedra, 36312, Spain
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Research Site
NOT_YET_RECRUITINGPozuelo de Alarcón, 28223, Spain
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Research Site
NOT_YET_RECRUITINGSantander, 39008, Spain
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Research Site
NOT_YET_RECRUITINGToledo, 45007, Spain
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Research Site
NOT_YET_RECRUITINGZaragoza, 50009, Spain
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Research Site
NOT_YET_RECRUITINGBasel, 4031, Switzerland
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Research Site
NOT_YET_RECRUITINGLiestal, CH-4410, Switzerland
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Research Site
NOT_YET_RECRUITINGRennaz, 1847, Switzerland
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Research Site
NOT_YET_RECRUITINGAbu Dhabi, 11241, United Arab Emirates
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Research Site
NOT_YET_RECRUITINGAl Ain City, 00000, United Arab Emirates
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Research Site
NOT_YET_RECRUITINGDubai, 505004, United Arab Emirates
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Research Site
NOT_YET_RECRUITINGMohammed Bin Zayed City, 92510, United Arab Emirates
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