CAMBRIA-2 is an international, multi-centre, open-label, randomised, Phase III trial for adult patients with ER-positive/HER2-negative early breast cancer and an intermediate-high or high risk of disease recurrence who have completed definitive locoregional treatment and have no evidence of disease.
Patients will be designated as having intermediate-high or high risk of recurrence based on clinical and genomic features. The primary aim is to assess if Camizestant results in improved invasive breast cancer-free survival compared to standard adjuvant therapy in patients with ERpositive/
HER2-negative early breast cancer with an intermediate-high or high risk of recurrence.
Globally, approximately 5500 patients will be randomised to the study within approximately 42 months. Participants will be randomised 1:1 to 'Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) ± Abemaciclib' or 'Camizestrant ± Abemaciclib'. Participants will attend clinic for treatment (7 years or until intolerance/discontinuation), ocular assessment, disease assessment and ongoing long-term follow-up until end of study.
- Category
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Trial status
Not yet recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
- Registry listing
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ERM Project ID
103579
Trial contact details
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Contact person
Dr Catherine Shannon
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Phone
07 3163 6166
What you need to know
Who can take part
Inclusion Criteria:
- Documented histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease.
- Pre-, peri-, and post-menopausal women, and men are eligible if they meet at least 1 of the criteria in the protocol
- Patients must have undergone adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s) with or without (neo) adjuvant systemic chemotherapy. Patients should be randomised within the first 12 weeks after radiation or the last chemotherapy dose (whichever is last).
- Performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Adequate bone marrow reserve and organ function as per the protocol
Exclusion criteria:
As per the protocol
What is involved for me
This is a Phase III, prospective, 2-arm, international, multicentre, randomised, open-label study to evaluate the effect of camizestrant compared to standard ET. The study will be conducted in approximately 700 sites in more than 40 countries. Approximately 5500 patients with ER+/HER2- early breast cancer will be randomised in a 1:1 ratio to one of the following treatment groups:
- Arm A: Patients will receive standard ET of investigator’s choice (AI [anastrozole, letrozole, or exemestane] or tamoxifen, standard dose per local guidelines, once daily) ± abemaciclib (standard dose as per approved local guidelines or per institutional SoC).
Pre- and peri-menopausal women and men will be treated with either AI or tamoxifen per investigator’s preference. In pre- and perimenopausal women, concurrent use of an LHRH agonist with either AI or tamoxifen is mandatory. In men, concurrent use of an LHRH agonist with AI is mandatory. - Arm B: Patients will receive camizestrant (75 mg once daily) ± abemaciclib (standard dose as per approved local guidelines or per institutional SoC). Pre- and peri-menopausal women and men will require concurrent use of an LHRH agonist.
