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
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
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.
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 of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).
Patients will be followed for 10 years from randomization of the last patient.
Inclusion Criteria:
Exclusion Criteria:
CABA, C1061, Argentina
Capital Federal, 1118, Argentina
Ciudad de Buenos Aires, 1426, Argentina
Ciudad de Buenos Aires, C1025ABI, Argentina
Ciudad de Buenos Aires, C1426ANZ, Argentina
Warnnambool, 3280, Australia
Shaoguan Shi, 512025, China
Suining Shi, 629000, China
Epagny Metz-Tessy, 74370, France
Hirakata-shi, 573-1191, Japan
Iruma-Gun, 350-0495, Japan
Isehara-shi, 259-1193, Japan
Kamogawa-shi, 296-0041, Japan
Kurume-shi, 830-0013, Japan
Ota-shi, 373-8550, Japan
Shinagawa-ku, 142-8666, Japan
Suita-shi, 565-0871, Japan
Sunto-gun, 411-8777, Japan
Takasaki-shi, 370-0829, Japan
Alc. Cuauhtémoc, 06100, Mexico
Alc. Cuauhtémoc, 06700, Mexico
Riyadh/MENA, 11426, Saudi Arabia
Cheonan-si, 31151, South Korea