An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Recruiting
Phase 3Interventional Study
Breast Cancer, Early Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 130
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
5,500 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with early-stage breast cancer that is hormone receptor-positive and HER2-negative. Participants will compare a new treatment called camizestrant to standard therapy for 7 years after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with early-stage breast cancer.
I have had surgery for my breast cancer.
I completed my surgery within the last 12 months.
I may have had up to 12 weeks of hormone therapy before joining.
I am in good overall health with manageable side effects.
My heart function is normal.
I have no metastatic disease.
You may not be able to join if
I have advanced or metastatic breast cancer.
I had a complete response to neoadjuvant therapy.
I have a history of cancer other than very low-risk skin cancer.
I have uncontrolled severe systemic diseases.
My heart function is poor with low ejection fraction.
I have a prolonged QTcF interval.
I am currently pregnant or breastfeeding.
I am allergic to camizestrant or similar medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
Trial Locations
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Eligibility 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 absence of any evidence of metastatic disease as defined in the protocol.
* Completed adequate (definitive) loco…
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 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 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 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.
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