At a glance
ClinicalIndex Comparison Record- ✓Women and Men aged ≥18 years
- ✓Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with no metastatic disease
- ✓Completed adequate locoregional therapy (surgery ± radiotherapy) ± (neo)adjuvant chemotherapy
- ✓Randomized within 12 months of definitive breast surgery
- ✕Inoperable locally advanced or metastatic breast cancer
- ✕Pathological complete response following neoadjuvant therapy
- ✕History of other cancer unless in complete remission for minimum 5 years (excludes non-melanoma skin cancer or cervical carcinoma in situ)
- ✕Severe or uncontrolled systemic disease precluding participation or compliance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
In Brief
A Phase 3 clinical trial evaluating Camizestrant, Tamoxifen, and 4 other interventions for Breast Cancer, Early Breast Cancer. Currently recruiting, targeting 5,500 participants across 798 sites in 44 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib
camizestrant ± abemaciclib
Interventions
Camizestrant. Experimental. Administered orally
Tamoxifen. Comparator. Administered orally
Anastrozole. Comparator. Administered orally
Letrozole. Comparator. Administered orally
Exemestane. Comparator. Administered orally
Abemaciclib adjuvant treatment Administered orally