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Looking for participantsPhase2

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

Sponsor: AstraZeneca

NCT ID: NCT07427394

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Camizestrant (drug), Atirmociclib (drug)
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
Camizestrant — drug: Camizestrant will be administered orally. · Atirmociclib — drug: Atirmociclib will be administered orally.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
24
Started
2026-05-06
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced breast cancer
  • • Phase2 - 24 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced breast cancer
  • • Female only

Where?

  • • Cambridge - Research Site
  • • London - Research Site
  • • Manchester - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib. The single-arm study includes: * Screening period * Atirmociclib single dose period * Doublet intervention period * Post-treatment follow-up period

Advanced Breast Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

ER

What the study is looking for

  • ✓Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance...
  • ✓that has spread or locoregionally recurrent disease and radiological or objective evidence of progression on or after the...
  • ✓activity scale (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum...
  • ✓Menopausal status
  • ✓Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout...

Who cannot take part

  • ✗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...
  • ✗Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.
  • ✗Inability to swallow oral medications.
See the full criteria
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 Is This Study? (3 UK sites)

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

London EC1M6BQ, United Kingdom

Recruiting

Research Site

Manchester M20 4GJ, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09