ER-Positive HER2-Negative Breast CancerPhase 3SERAFA-1NCT07647328
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
A Phase 3 study testing Camizestrant and Ribociclib in people with ER-Positive HER2-Negative Breast Cancer, run by AstraZeneca at 89 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- ER-Positive HER2-Negative Breast Cancer
- What is being tested?
- Camizestrant and Ribociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 89 sitesin 9 countries
- Study dates
- 15 Jun 2026to 28 Feb 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent.
- Female or male, must be ≥ 18 years or as per locally allowed age limit for screening.
- Type of Participant and Disease Characteristics
- 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.
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- 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.
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- ECOG performance status of 0 or 1.
- Adequate organ and marrow function. Sex and Contraceptive/Barrier Requirements
- 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:
- 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.
- 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.
Who cannot join
- Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.
- No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.
- Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.
- Persistent treatment-induced non-haematological toxicities (CTCAE Grade > 2).
- Known active infection including tuberculosis HBV and HCV.
- Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines.
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- Any clinically important abnormalities in heart conduction patterns; participants with pacemakers or medically controlled atrial fibrillation are not excluded.
- Ongoing symptomatic hypotension.
- Pregnant or lactating women or patients not willing to use highly effective contraception as defined in the protocol.
Trial locations and contacts
89 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
89 sites in 9 countries
Spain18 sites, 18 recruiting
- Not yet recruiting
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Badajoz, 06080
- Not yet recruiting
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Badalona, 08916
- Not yet recruiting
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Barcelona, 08041
- Not yet recruiting
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Burgos, 9006
- Not yet recruiting
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Donostia / San Sebastian, 20014
- Not yet recruiting
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Huelva, 21005
- Not yet recruiting
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Jaén, 23007
- Not yet recruiting
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Las Palmas de Gran Canaria, 35016
- Not yet recruiting
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Majadahonda, 28222
- Not yet recruiting
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Málaga, 29010
- Not yet recruiting
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Murcia, 30008
- Not yet recruiting
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Oviedo, 33011
- Not yet recruiting
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Palma de Mallorca, 07198
- Not yet recruiting
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Pontevedra, 36312
- Not yet recruiting
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Pozuelo de Alarcón, 28223
- Not yet recruiting
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Santander, 39008
- Not yet recruiting
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Toledo, 45007
- Not yet recruiting
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Zaragoza, 50009
South Korea16 sites, 14 recruiting
- Not yet recruiting
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Cheonan-si, 31151
- Suspended
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Daegu, 42415
- Not yet recruiting
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Goyang-si, 10408
- Not yet recruiting
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Hwasun-eup, 58128
- Not yet recruiting
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Incheon, 405-760
- Not yet recruiting
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Seongbuk-Gu, 02841
- Not yet recruiting
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Seongnam-si, 13520
- Not yet recruiting
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Seongnam-si, 13620
- Not yet recruiting
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Seoul, 03080
- Not yet recruiting
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Seoul, 06273
- Not yet recruiting
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Seoul, 06351
- Not yet recruiting
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Seoul, 06591
- Not yet recruiting
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Seoul, 07985
- Not yet recruiting
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Seoul, 3722
- Not yet recruiting
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Songpa-gu, 05505
- Suspended
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Suwon, 16499
France14 sites, 14 recruiting
- Not yet recruiting
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Angers, 49933
- Not yet recruiting
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Bayonne, 64109
- Not yet recruiting
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Bobigny, 93000
- Not yet recruiting
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Caen, 14000
- Not yet recruiting
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Chambray-lès-Tours, 37170
- Not yet recruiting
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Grenoble, 38043
- Not yet recruiting
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Montpellier, 34070
- Not yet recruiting
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Nancy, 54100
- Not yet recruiting
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Nîmes, 30029
- Not yet recruiting
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Paris, 75014
- Not yet recruiting
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Pierre-Bénite, 69310
- Not yet recruiting
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Valenciennes, 59300
- Not yet recruiting
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Vandœuvre-lès-Nancy, 54519
- Not yet recruiting
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Villejuif, 94805
United States12 sites, 12 recruiting
- Not yet recruiting
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Duarte, California, 91010
- Recruiting
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Edgewood, Kentucky, 41017
- Not yet recruiting
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Evanston, Illinois, 60201
- Recruiting
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Fort Worth, Texas, 76104
- Recruiting
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Kingwood, Texas, 77339
- Not yet recruiting
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Louisville, Kentucky, 40202
- Recruiting
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Marietta, Georgia, 30060
- Not yet recruiting
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Midlothian, Virginia, 23114
- Not yet recruiting
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Nashville, Tennessee, 37204
- Not yet recruiting
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Palo Alto, California, 94304
- Not yet recruiting
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Reno, Nevada, 89502
- Not yet recruiting
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Sioux Falls, South Dakota, 57105
Germany9 sites, 9 recruiting
- Not yet recruiting
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Berlin, 13125
- Not yet recruiting
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Düsseldorf, 40235
- Not yet recruiting
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Erlangen, 91054
- Not yet recruiting
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Freiburg im Breisgau, 79110
- Not yet recruiting
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Mönchengladbach, 41061
- Not yet recruiting
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München, 81675
- Not yet recruiting
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Paderborn, 33098
- Not yet recruiting
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Trier, 54290
- Not yet recruiting
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Velbert, 42551
Poland8 sites, 7 recruiting
- Not yet recruiting
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Gdansk, 80-952
- Not yet recruiting
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Konin, 62-500
- Not yet recruiting
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Krakow, 30-688
- Not yet recruiting
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Lodz, 90-302
- Not yet recruiting
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Lublin, 20-090
- Not yet recruiting
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Poznan, 61-485
- Suspended
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Przemyśl, 37-700
- Not yet recruiting
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Wroclaw, 53-413
Italy5 sites, 5 recruiting
- Not yet recruiting
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Aviano, 33081
- Not yet recruiting
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Bergamo, 24127
- Not yet recruiting
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Genova, 16132
- Not yet recruiting
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Milan, 20127
- Not yet recruiting
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Naples, 80131
United Arab Emirates4 sites, 4 recruiting
- Not yet recruiting
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Abu Dhabi, 11241
- Not yet recruiting
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Al Ain City, 00000
- Not yet recruiting
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Dubai, 505004
- Not yet recruiting
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Mohammed Bin Zayed City, 92510
Switzerland3 sites, 3 recruiting
- Not yet recruiting
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Basel, 4031
- Not yet recruiting
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Liestal, CH-4410
- Not yet recruiting
Research Site
Rennaz, 1847
About this study
Official title: SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients
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.
Read the 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.
- Conditions
- ER-Positive HER2-Negative Breast Cancer
- Being tested
- Camizestrant, Ribociclib
- Keywords
- Metastatic, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Next Generation Oral SERD, Antineoplastic Agents, Estrogen Receptor Antagonists, Camizestrant
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamizestrantDrug
Also called AZD9833
Patients will receive the standard dose of camizestrant once daily as oral tablets
RibociclibDrug
Also called KISQALI®
Patients will receive the standard dose of ribociclib once daily as oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Camizestrant and Ribociclib | Experimental | Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets Receives: Drug: Camizestrant; Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)
TTNT is defined as time from the date of the first administration of study treatment to the earliest start date of subsequent anti-cancer medication or death.
The primary measure of interest is the TTNT event-free rate at 2 years.
Measured: Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment.
Secondary outcomes (3)
Efficacy of camizestrant and ribociclib by time to discontinuation (TTD)
TTD is defined as time from the date of the first administration of study treatment to the earliest date of camizestrant treatment discontinuation or death.
The primary measure of interest is the TTD event-free rate at 2 years.
Measured: Following first dose of study treatment until earliest of discontinuation of camizestrant, death and 2 years after first dose of study treatment
Efficacy of camizestrant and ribociclib by progression free survival (PFS)
PFS is defined as time from first dose of study treatment until progression per RECIST 1.1 as assessed by investigator or death due to any cause.
The primary measures of interest are the PFS event-free rates at 1 and 2 years.
Measured: Following first dose of study treatment until earliest of death, disease progression, and 2 years after first dose of study treatment.
CTCAE grade ≥ 3 associated with camizestrant and ribociclib within first 6 months of study treatment
Incidence of Grade >=3 CTCAEs associated with Camizestrant and/or Ribo within first 6 months of receiving study treatment.
Measured: Following first dose of study treatment until 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Jun 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER-Positive HER2-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Interventional, prospective, single-arm, open-label study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647328
- Sponsor's protocol ID
- D8532C00008
- Acronym
- SERAFA-1
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure