Camizestrant plus atirmociclib in ER-positive, HER2-negative advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2a, open-label study will evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of camizestrant in combination with atirmociclib in eligible patients. It uses a sequential, single-arm design with screening, a single-dose period for atirmociclib, a doublet intervention period, and a post-treatment follow-up. Participants must have advanced breast cancer with progression after prior CDK4/6 inhibitor therapy and meet ECOG 0-1 criteria, among other eligibility factors. The trial is led by AstraZeneca with sites in St. Louis, East Providence, and Nashville.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  St Louis, Missouri, United States Recruiting
• Research Site
  East Providence, Rhode Island, United States Recruiting
• Research Site
  Nashville, Tennessee, United States Recruiting
• Research Site
  Cambridge, United Kingdom Recruiting
• Research Site
  London, United Kingdom Recruiting
• Research Site
  Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.