Clinical trial · Interventional
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atirmociclib | Drug | — | UNRESOLVED |
| Camizestrant | Drug | Camizestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camizestrant + Atirmociclib
- description
- Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1.
- interventionNames
- Drug: Camizestrant
- Drug: Atirmociclib
Primary outcomes (1)
- measure
- Number of participants with adverse events (AEs) and serious AEs
- timeFrame
- Up to Post-Treatment Follow up (Day 30 Post Dose)
- description
- To investigate the safety and tolerability of camizestrant in combination with atirmociclib.
Secondary outcomes (20)
- measure
- Maximum concentration observed (Cmax)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available