Camizestrant plus atirmociclib for advanced ER-positive, HER2-negative breast cancer
Tests camizestrant with atirmociclib in women whose advanced breast cancer was treated before.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
Key facts
- Where
- Cambridge, London, and Manchester, United KingdomSee the 3 sites
- Phase
- Phase 2
Where in United Kingdom
- CambridgeCambridge, United KingdomTaking people
- LondonLondon, United KingdomTaking people
- ManchesterManchester, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07427394
- Record updated
- 29 September 2026
- Original description
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.Read full original descriptionShow less
A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.
Main Inclusion Criteria:; Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease; Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products; Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks; At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination; Menopausal status; Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study; Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age <60 years with ≥12 months amenorrhea and post-menopausal hormone levels; Histological or cytological confirmation of adenocarcinoma of the breast; Participants of childbearing potential must agree to use one highly effective contraceptive measure; Documentation of ER-positive tumor irrespective of progesterone receptor status; Main Exclusion Criteria:; A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting; A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting; Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting; Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible; Inability to swallow oral medications; Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia); Presence of life-threatening metastatic visceral disease; Any evidence of severe or uncontrolled systemic diseases; Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.