An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
- Trial number:
- NCT05952557
- Trial phase:
- 3
- Study type:
- Hormonal therapy
- Overall status:
- Recruiting
Study start date
October, 2023
Scientific title
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
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.
* 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
Study design
Primary purpose:
TREATMENT, Allocation:
RANDOMIZED, Intervention model:
PARALLEL, Intervention model description:
Patients will be randomised in a 1:1 ratio to one of the following arms, Masking:
NONE,
Conditions
Breast Cancer, Early Breast Cancer
Other study ID numbers
2023-504031-41-00; D8535C00001
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Fountain Valley, CA 92708, USA
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Los Angeles, CA 90017, USA
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Monterey, CA, USA
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Gainesville, FL 32610, USA
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Fort Lauderdale, FL 33322, USA
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Plantation, FL, USA
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Research Dr NW, Atlanta, GA 30318, USA
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Columbus, GA 31904, USA
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Savannah, GA 31404, USA
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Thomasville, GA, USA
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Fairway, KS 66205, USA
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New Orleans, LA 70121, USA
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Baltimore, MD 21201, USA
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Bethesda, MD 20817, USA
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Loch Raven, MD 21204, USA
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Boston, MA 02111, USA
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Hyannis, Barnstable, MA 02601, USA
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Worcester, MA 01655, USA
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Kansas City, MO 64111, USA
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New Brunswick, NJ 08901, USA
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Farmington, NM, USA
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North New Hyde Park, NY 11042, USA
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White Plains, NY 10601, USA
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Youngstown, OH 44504, USA
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Sayre, PA 18840, USA
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Greenville, SC 29605, USA
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Rock Hill, SC 29732, USA
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Sioux Falls, SD 57105, USA
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Knoxville, TN 37909, USA
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Research Dr, Knoxville, TN 37932, USA
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Memphis, TN 38120, USA
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Spokane, WA 99202, USA
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C1061 Buenos Aires, Argentina
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Dendy VIC 3186, Australia
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