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.
Detailed description
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.
Arms & interventions
- DrugCamizestrant
Camizestrant. Experimental. Administered orally
- DrugTamoxifen
Tamoxifen. Comparator. Administered orally
- DrugAnastrozole
Anastrozole. Comparator. Administered orally
- DrugLetrozole
Letrozole. Comparator. Administered orally
- DrugExemestane
Exemestane. Comparator. Administered orally
- DrugAbemaciclib
Abemaciclib adjuvant treatment Administered orally
Outcome measures
Primary
Invasive breast cancer-free survival (IBCFS)
IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Death attributable to any cause.
Time frame: Up to 14 years
Secondary
Invasive disease-free survival (IDFS)
Time frame: Up to 14 years
Distant relapse-free survival (DRFS)
Time frame: Up to 14 years
Overall survival (OS)
Time frame: Up to 14 years
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
Time frame: Until 28 days after the final dose of study treatment (up to 7 years)
Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.
Time frame: Until 28 days after the final dose of study treatment (up to 7 years)
Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311
Time frame: Until 28 days after the final dose of study treatment (up to 7 years)
Pharmacokinetics (PK)
Time frame: Until 6 months from treatment start
Eligibility criteria
Study locations (148)
Research Site
Dothan, Alabama, 36303
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Phoenix, Arizona, 85054
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Tucson, Arizona, 85745
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Fayetteville, Arkansas, 72703
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Duarte, California, 91010
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Fountain Valley, California, 92708
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Greenbrae, California, 94904
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Irvine, California, 92618
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La Jolla, California, 92093
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Los Angeles, California, 90017
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Monterey, California, 93940
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Walnut Creek, California, 94598
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West Hollywood, California, 90048
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Aurora, Colorado, 80045
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Littleton, Colorado, 80120
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Littleton, Colorado, 80129
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New Haven, Connecticut, 06510
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Newark, Delaware, 19713
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Washington D.C., District of Columbia, 20016
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Clearwater, Florida, 33756
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Fort Myers, Florida, 33901
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Gainesville, Florida, 32610
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Jacksonville, Florida, 32224
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Orlando, Florida, 32806
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Pembroke Pines, Florida, 33028
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Plantation, Florida, 33322
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Plantation, Florida, 33324
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St. Petersburg, Florida, 33705
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St. Petersburg, Florida, 33709
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Tallahassee, Florida, 32308
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West Palm Beach, Florida, 33401
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Atlanta, Georgia, 30318
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Atlanta, Georgia, 30322
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Columbus, Georgia, 31904
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Marietta, Georgia, 30060
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Savannah, Georgia, 31404
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Thomasville, Georgia, 31792
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Chicago, Illinois, 60637
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Elmhurst, Illinois, 60126
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Naperville, Illinois, 60540
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Park Ridge, Illinois, 60068
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Plainfield, Illinois, 60585
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Urbana, Illinois, 61801
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Fort Wayne, Indiana, 46804
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Des Moines, Iowa, 50309
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Fairway, Kansas, 66205
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Louisville, Kentucky, 40202
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New Orleans, Louisiana, 70121
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Scarborough, Maine, 04074
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Annapolis, Maryland, 21401
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21287
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Bethesda, Maryland, 20817
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Lutherville, Maryland, 21093
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Towson, Maryland, 21204
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Boston, Massachusetts, 02111
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Boston, Massachusetts, 02115
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Hyannis, Massachusetts, 02601
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Worcester, Massachusetts, 01655
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Detroit, Michigan, 48202
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Flint, Michigan, 48503
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Ypsilanti, Michigan, 48197
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Minneapolis, Minnesota, 55416
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Rochester, Minnesota, 55905
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Kansas City, Missouri, 64111
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St Louis, Missouri, 63110
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St Louis, Missouri, 63131
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Lincoln, Nebraska, 68506
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Omaha, Nebraska, 68124
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Omaha, Nebraska, 68198
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Hooksett, New Hampshire, 03106
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Lebanon, New Hampshire, 03756
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Manchester, New Hampshire, 03103
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New Brunswick, New Jersey, 08901
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Albuquerque, New Mexico, 87109
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Farmington, New Mexico, 87401
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Bay Shore, New York, 11706
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East Syracuse, New York, 13057
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Greenlawn, New York, 11740
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New Hyde Park, New York, 11042
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New York, New York, 10029
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New York, New York, 10065
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New York, New York, 10065
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Stony Brook, New York, 11794
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White Plains, New York, 10601
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Charlotte, North Carolina, 28204
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Durham, North Carolina, 27710
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Greensboro, North Carolina, 27403
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Greenville, North Carolina, 27834
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Pinehurst, North Carolina, 28374
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Raleigh, North Carolina, 27607
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Winston-Salem, North Carolina, 27103
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Blue Ash, Ohio, 45242
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Cincinnati, Ohio, 45255
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Cleveland, Ohio, 44106
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Columbus, Ohio, 43212
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Toledo, Ohio, 43623
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Youngstown, Ohio, 44504
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Oklahoma City, Oklahoma, 73104
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Portland, Oregon, 97210
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Portland, Oregon, 97213
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Portland, Oregon, 97225
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Gettysburg, Pennsylvania, 17325
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Hershey, Pennsylvania, 17033
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Philadelphia, Pennsylvania, 19104
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Pittsburgh, Pennsylvania, 15213
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Sayre, Pennsylvania, 18840
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York, Pennsylvania, 17403
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Charleston, South Carolina, 29425
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Greenville, South Carolina, 29605
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Rock Hill, South Carolina, 29732
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Spartanburg, South Carolina, 29303
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Aberdeen, South Dakota, 57401
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Sioux Falls, South Dakota, 57105
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Chattanooga, Tennessee, 37404
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Knoxville, Tennessee, 37909
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Knoxville, Tennessee, 37920
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Memphis, Tennessee, 38120
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Nashville, Tennessee, 37203
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Nashville, Tennessee, 37232
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Austin, Texas, 78731
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Bedford, Texas, 76022
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Dallas, Texas, 75230
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Dallas, Texas, 75231
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Dallas, Texas, 75246
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El Paso, Texas, 79902
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Flower Mound, Texas, 75028
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Houston, Texas, 77024
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Houston, Texas, 77030
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Plano, Texas, 75075
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San Antonio, Texas, 78217
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Tyler, Texas, 75702
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Salt Lake City, Utah, 84112
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Charlottesville, Virginia, 22908
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Fairfax, Virginia, 22031
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Midlothian, Virginia, 23114
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Norfolk, Virginia, 23502
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Richmond, Virginia, 23219
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Roanoke, Virginia, 24014
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Winchester, Virginia, 22601
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Puyallup, Washington, 98373
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Spokane, Washington, 99202
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Vancouver, Washington, 98684
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Charleston, West Virginia, 25304
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Morgantown, West Virginia, 26505
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Appleton, Wisconsin, 54911
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Madison, Wisconsin, 53792
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Milwaukee, Wisconsin, 53215
References
- Hamilton EP, Loibl S, Bachelot T, Gnant M, Niikura N, Park YH, Tolaney SM, Pistilli B, Rastogi P, Saini KS, Gioni I, Johnston S, Nunes R, Quintana A, Stuart M, Syta E, Walding A, Klinowska T, Mayer IA. CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2- early breast cancer. Future Oncol. 2025 Mar;21(7):795-806. doi: 10.1080/14796694.2025.2459548. Epub 2025 Feb 27.(PubMed)