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Evaluating camizestrant for early breast cancer after standard therapy

CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

PHASE3 · AstraZeneca · NCT05774951

This study is testing if a new drug called camizestrant can help women with early breast cancer who have finished standard hormone therapy to live longer and stay cancer-free.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment4300 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsdenosumab, chemotherapy
Locations711 sites (Birmingham, Alabama and 710 other locations)
Trial IDNCT05774951 on ClinicalTrials.gov

What this trial studies

This Phase III open-label study investigates whether camizestrant can enhance outcomes for patients with ER+/HER2- early breast cancer who have completed at least 2 years of standard adjuvant endocrine therapy. Participants must have undergone definitive locoregional therapy and be at intermediate or high risk for disease recurrence. The study will compare the effectiveness of camizestrant against standard endocrine therapies over a planned treatment duration of 60 months, with follow-up lasting up to 10 years. Key endpoints include invasive breast cancer-free survival and overall survival, among others.

Who should consider this trial

Good fit: Ideal candidates are adults with ER+/HER2- early-stage breast cancer who have completed standard adjuvant endocrine therapy and are at intermediate or high risk of recurrence.

Not a fit: Patients with inoperable locally advanced or metastatic breast cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with early breast cancer at risk of recurrence.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific use of camizestrant is being evaluated in a Phase III setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Women and Men, ≥18 years at the time of screening (or per national guidelines)
* Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
* Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Adequate organ and marrow function

Exclusion criteria:

* Inoperable locally advanced or metastatic breast cancer
* Pathological complete response following treatment with neoadjuvant therapy
* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance
* Known LVEF \<50% with heart failure NYHA Grade ≥2.
* Mean resting QTcF interval \>480 ms at screening
* Concurrent exogenous sex hormone therapy
* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
* Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding
* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist

Where this trial is running

Birmingham, Alabama and 710 other locations

+661 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Breast Cancer, Early Breast Cancer, ER+, HER2-, breast cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.