Recruiting
Phase 2

Camizestrant & Atirmociclib

Sponsor:

AstraZeneca

Code:

NCT07427394

Conditions

Advanced Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Camizestrant

Atirmociclib

Study Details

Brief summary:

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

Advanced Breast Cancer

Study ID

NCT07427394

Start date

May 6, 2026

Status verified date

Sep, 2026

Completion date

Dec 28, 2027

Anticipated

Primary completion date

Dec 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Camizestrant + Atirmociclib

Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1.

Interventions

Camizestrant

Camizestrant will be administered orally.

Atirmociclib

Atirmociclib will be administered orally.

Primary outcome measure

  • Number of participants with adverse events (AEs) and serious AEs [ Time Frame: Up to Post-Treatment Follow up (Day 30 Post Dose) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

St Louis, Missouri, United States, 63108

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

AstraZeneca

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Estrogen receptor (ER)-positive
  • Human epidermal growth factor receptor 2 (HER2)-negative
  • Cyclin-Dependent Kinase (CDK) 4 inhibitors
  • Pharmacokinetics
  • Anti-tumor activity
  • Selective Estrogen Receptor Degrader (SERD)
  • Safety
  • Tolerability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-03.