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An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
EU CTIS ID: 2023-504031-41-00
What this study is testing
To demonstrate superiority of camizestrant ± abemaciclib as compared to standard endocrine therapy ± abemaciclib in preventing breast cancer recurrence
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 either in the adjuvant orneoadjuvant setting prior to randomisation
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Adequate organ and marrow function
You likely can't join if
- Inoperable locally advanced or metastatic breast cancer
- 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
- 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
See the full eligibility 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 either in the adjuvant orneoadjuvant setting prior to randomisation
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Adequate organ and marrow function
- Inoperable locally advanced or metastatic breast cancer
- 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
- 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
- SUB-STUDY ONLY: Initiation of restricted medications prior to randomisation in main study. Patients assessed as not able to comply with study procedures, restrictions, and requirements
- SUB-STUDY ONLY: Comorbidities or concomitant medications; ongoing skin conditions, bleeding of unknown aetiology that might impact assessment of sub-study objectives.
- 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
- For PORTUGAL ONLY: Patients with known germline or somatic BRCA1/2 mutations.
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Saudi Arabia
- Switzerland
- Argentina
- Korea, Republic of
- Serbia
- Malaysia
- New Zealand
- United Kingdom
- Japan
- Turkey
- Mexico
- Chile
- Australia
- India
- Philippines
- United States
- China
- Taiwan
- Israel
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Saudi Arabia; Switzerland; Argentina; Korea, Republic of; Serbia and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.