Back to search results

CAMBRIA-2 Study: Camizestrant for Early Breast Cancer

This study is testing a new oral medicine called camizestrant for people with early-stage breast cancer that is hormone receptor-positive (ER+) and HER2-negative (HER2-). This type of cancer responds to hormones and does not have too much of the HER2 protein. Researchers want to see if camizestrant works better than standard hormone therapies like tamoxifen, anastrozole, letrozole, or exemestane at preventing the cancer from coming back. You could be eligible if you are 18 or older, have ER+/HER2- early breast cancer, and have completed surgery or other local treatments. The main goal is to see how long people live without the cancer coming back in the breast or other parts of the body. The study is currently unclear on its recruitment status.

Study design
This is a Phase III, open-label study, meaning both you and your doctor will know which treatment you are receiving. It plans to enroll about 5500 participants.
What's involved
You would take the study medicine for 7 years. The record does not specify the number of visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
After your treatment, you will be followed for up to 14 years to see if the cancer returns. All patients will be followed for 10 years from the time the last patient is randomly assigned to a treatment group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05952557

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~5,511 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:CamizestrantTamoxifenAnastrozoleLetrozoleExemestaneAbemaciclib

At a glance

Recruiting sites
0 of 661 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Invasive breast cancer-free survival (IBCFS)
Measured over Up to 14 years

Conditions

Breast Cancer, Early Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

661 sites across 83 states
China60
Spain50
Japan33
Brazil31
Germany27
Australia24
France23
United Kingdom20

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 absence of any evidence of metastatic disease 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.
Patients must be randomised within 12 months of definitive breast surgery.
Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Adequate organ and bone marrow function

Exclusion

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 a 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 reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
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.

What this trial measures

  • Invasive breast cancer-free survival (IBCFS)Up to 14 years

    IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Death attributable to any cause.