An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
CAMBRIA-2
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
2 other identifiers
interventional
5,500
42 countries
730
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2023
Longer than P75 for phase_3
730 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 6, 2037
June 19, 2025
June 1, 2025
6.4 years
May 17, 2023
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 14 years
Secondary Outcomes (7)
Invasive disease-free survival (IDFS)
Up to 14 years
Distant relapse-free survival (DRFS)
Up to 14 years
Overall survival (OS)
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)
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.
Until 28 days after the final dose of study treatment (up to 7 years)
- +2 more secondary outcomes
Study Arms (2)
Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
ACTIVE COMPARATORstandard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib
Arm B: camizestrant ± abemaciclib
EXPERIMENTALcamizestrant ± 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inoperable locally advanced or metastatic breast cancer
- Pathological complete response following treatment with neoadjuvant therapy
- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
- Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
- Known LVEF \<50% with heart failure NYHA Grade ≥2.
- Mean resting QTcF interval \> 480 ms at screening
- Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
- Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
- Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
- Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (794)
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Dothan, Alabama, 36303, United States
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Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85745, United States
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Fayetteville, Arkansas, 72703, United States
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Duarte, California, 91010, United States
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Fountain Valley, California, 92708, United States
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Greenbrae, California, 94904, United States
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Irvine, California, 92618, United States
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La Jolla, California, 92093, United States
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Los Angeles, California, 90017, United States
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Monterey, California, 93940, United States
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Walnut Creek, California, 94598, United States
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West Hollywood, California, 90048, United States
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Aurora, Colorado, 80045, United States
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Littleton, Colorado, 80120, United States
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Littleton, Colorado, 80129, United States
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New Haven, Connecticut, 06510, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20016, United States
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Clearwater, Florida, 33756, United States
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Fort Myers, Florida, 33901, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32224, United States
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Orlando, Florida, 32806, United States
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Pembroke Pines, Florida, 33028, United States
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Plantation, Florida, 33322, United States
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Plantation, Florida, 33324, United States
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St. Petersburg, Florida, 33705, United States
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St. Petersburg, Florida, 33709, United States
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Tallahassee, Florida, 32308, United States
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West Palm Beach, Florida, 33401, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Columbus, Georgia, 31904, United States
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Marietta, Georgia, 30060, United States
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Savannah, Georgia, 31404, United States
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Thomasville, Georgia, 31792, United States
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Chicago, Illinois, 60637, United States
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Elmhurst, Illinois, 60126, United States
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Naperville, Illinois, 60540, United States
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Park Ridge, Illinois, 60068, United States
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Plainfield, Illinois, 60585, United States
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Urbana, Illinois, 61801, United States
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Fort Wayne, Indiana, 46804, United States
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Des Moines, Iowa, 50309, United States
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Fairway, Kansas, 66205, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70121, United States
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Scarborough, Maine, 04074, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287, United States
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Bethesda, Maryland, 20817, United States
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Lutherville, Maryland, 21093, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02115, United States
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Hyannis, Massachusetts, 02601, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Flint, Michigan, 48503, United States
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Ypsilanti, Michigan, 48197, United States
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Minneapolis, Minnesota, 55416, United States
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Rochester, Minnesota, 55905, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63131, United States
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Lincoln, Nebraska, 68506, United States
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Omaha, Nebraska, 68124, United States
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Omaha, Nebraska, 68198, United States
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Hooksett, New Hampshire, 03106, United States
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Lebanon, New Hampshire, 03756, United States
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Manchester, New Hampshire, 03103, United States
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New Brunswick, New Jersey, 08901, United States
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Albuquerque, New Mexico, 87109, United States
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Farmington, New Mexico, 87401, United States
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Bay Shore, New York, 11706, United States
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East Syracuse, New York, 13057, United States
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Greenlawn, New York, 11740, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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New York, New York, 10065, United States
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Stony Brook, New York, 11794, United States
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White Plains, New York, 10601, United States
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Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27710, United States
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Greensboro, North Carolina, 27403, United States
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Greenville, North Carolina, 27834, United States
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Pinehurst, North Carolina, 28374, United States
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Raleigh, North Carolina, 27607, United States
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Winston-Salem, North Carolina, 27103, United States
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Blue Ash, Ohio, 45242, United States
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Cincinnati, Ohio, 45255, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 43212, United States
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Toledo, Ohio, 43623, United States
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Youngstown, Ohio, 44504, United States
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Oklahoma City, Oklahoma, 73104, United States
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Portland, Oregon, 97210, United States
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Portland, Oregon, 97213, United States
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Portland, Oregon, 97225, United States
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Gettysburg, Pennsylvania, 17325, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Sayre, Pennsylvania, 18840, United States
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York, Pennsylvania, 17403, United States
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Charleston, South Carolina, 29425, United States
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Greenville, South Carolina, 29605, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Aberdeen, South Dakota, 57401, United States
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Sioux Falls, South Dakota, 57105, United States
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Chattanooga, Tennessee, 37404, United States
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Knoxville, Tennessee, 37909, United States
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Knoxville, Tennessee, 37920, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78731, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75246, United States
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El Paso, Texas, 79902, United States
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Flower Mound, Texas, 75028, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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Plano, Texas, 75075, United States
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San Antonio, Texas, 78217, United States
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Tyler, Texas, 75702, United States
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Salt Lake City, Utah, 84112, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Midlothian, Virginia, 23114, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23219, United States
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Roanoke, Virginia, 24014, United States
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Winchester, Virginia, 22601, United States
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Puyallup, Washington, 98373, United States
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Spokane, Washington, 99202, United States
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Vancouver, Washington, 98684, United States
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Charleston, West Virginia, 25304, United States
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Morgantown, West Virginia, 26505, United States
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Appleton, Wisconsin, 54911, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53215, United States
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Buenos Aires, 1426, Argentina
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Buenos Aires, C1025ABI, Argentina
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Buenos Aires, C1417, Argentina
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Buenos Aires, C1426ANZ, Argentina
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CABA, C1061, Argentina
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Capital Federal, 1118, Argentina
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Córdoba, 5001, Argentina
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Córdoba, X5800HHW, Argentina
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La Plata, 1900, Argentina
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Rosario, 2123, Argentina
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San Juan, 5400, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Viedma, R8500ACE, Argentina
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Adelaide, 5081, Australia
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Bankstown, 2200, Australia
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Bendigo, 3550, Australia
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Bowral, 2576, Australia
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Brighton, 3186, Australia
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Clayton, 3168, Australia
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Coffs Harbour, 2450, Australia
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Fitzroy, 3065, Australia
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Frankston, 3199, Australia
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Garran, 2605, Australia
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Gateshead, 2290, Australia
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Heidelberg, 3084, Australia
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Liverpool, 2170, Australia
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Melbourne, 3004, Australia
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Murdoch, WA6150, Australia
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Randwick, 2031, Australia
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Richmond, 3121, Australia
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Shepparton, 3630, Australia
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South Brisbane, 4101, Australia
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St Leonards, 2065, Australia
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Subiaco, 6008, Australia
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Traralgon, 3844, Australia
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Wangaratta, 3677, Australia
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Waratah, 2298, Australia
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Warnnambool, 3280, Australia
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Wollongong, 2500, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Klagenfurt, 9020, Austria
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Linz, 4010, Austria
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Linz, 4021, Austria
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Salzburg, 5020, Austria
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Sankt Veit an der Glan, 9300, Austria
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Steyr, 4400, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Vienna, 1160, Austria
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Vienna, 1180, Austria
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Wels, 4600, Austria
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Wiener Neustadt, 2700, Austria
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Aalst, 9300, Belgium
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Anderlecht, 1070, Belgium
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Brasschaat, 2930, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Namur, 5000, Belgium
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Wilrijk, 2610, Belgium
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Alfenas, 37130-000, Brazil
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Belo Horizonte, 30130-100, Brazil
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Blumenau, 89010-340, Brazil
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Brasília, 71615-907, Brazil
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Curitiba, 80730-380, Brazil
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Curitiba, 80810-050, Brazil
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Fortaleza, 60135-237, Brazil
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Fortaleza, 60430-230, Brazil
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Goiânia, 74000-000, Brazil
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Itajaí, 88301-220, Brazil
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João Pessoa, 58013-140, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90035-001, Brazil
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Porto Alegre, 90050-170, Brazil
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Porto Alegre, 90610000, Brazil
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Porto Velho, 76834-899, Brazil
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Pouso Alegre, 37554-216, Brazil
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Recife, 50070-480, Brazil
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Ribeirão Preto, 14015-130, Brazil
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Rio de Janeiro, 20560-120, Brazil
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Rio de Janeiro, 22793-080, Brazil
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Salvador, 40170-110, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 01409-902, Brazil
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São Paulo, 03102-006, Brazil
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Taubaté, 12030-200, Brazil
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Teresina, 64049-200, Brazil
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Três Lagoas, 79601-001, Brazil
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Vitória, 29043-260, Brazil
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Dobrich, 9300, Bulgaria
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Haskovo, 6300, Bulgaria
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Plovdiv, 4002, Bulgaria
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Plovdiv, 4004, Bulgaria
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Shumen, 9700, Bulgaria
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Sofia, 1330, Bulgaria
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Sofia, 1404, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Varna, 9010, Bulgaria
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Vratsa, 3000, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, t6G1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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North Vancouver, British Columbia, V7L 2L7, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Sault Ste. Marie, Ontario, P6A 0A8, Canada
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Thunder Bay, Ontario, P7B 6V4, Canada
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Windsor, Ontario, N8W 2X3, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Lévis, Quebec, G6V 3Z1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Concepción, 4070196, Chile
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La Serena, 1720430, Chile
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Port Montt, 5500243, Chile
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Providencia, 7510032, Chile
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Santiago, 7620157, Chile
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Santiago, 8150215, Chile
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Santiago, 8330032, Chile
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Santiago, 8330336, Chile
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Temuco, 4810218, Chile
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Viña del Mar, 2520000, Chile
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Baoding, 071000, China
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Beijing, 100021, China
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Beijing, 100039, China
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Beijing, 100142, China
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Beijing, 100191, China
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Beijing, 100730, China
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Bengbu, 233004, China
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Binzhou, 256606, China
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Cangzhou, 061001, China
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Changchun, 130021, China
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Changsha, 410008, China
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Chengdu, 610042, China
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Chengdu, 610072, China
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Chifeng, 024000, China
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Dalian, 116011, China
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Foshan, 528000, China
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Fuzhou, 350014, China
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Guangzhou, 510060, China
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Guangzhou, 510080, China
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Guangzhou, 510168, China
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Haikou, 570311, China
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Haikou, 570311, China
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Hangzhou, 310000, China
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Hangzhou, 310009, China
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Hangzhou, 310016, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Hefei, 230012, China
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Hefei, 230022, China
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Hefei, 230601, China
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Hohhot, 010017, China
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Huizhou, 516001, China
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Jinzhou, 121001, China
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Lanzhou, 730050, China
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Linyi, 276000, China
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Liuchow, 545005, China
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Liuchow, 545006, China
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Nanchang, 330009, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Nantong, 226001, China
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Neijiang, 641000, China
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Shandong, 250117, China
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Shangqiu, 476100, China
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Shantou, 515031, China
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Shaoguan Shi, 512025, China
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Shenyang, 110001, China
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Shenyang, 110042, China
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Shenzhen, 518020, China
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Shenzhen, 518116, China
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Shijiazhuang, 050011, China
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Suining Shi, 629000, China
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Suzhou, 215004, China
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Suzhou, 215006, China
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Suzhou, 215600, China
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Taizhou, 317000, China
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Tianjin, 300060, China
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Weifang, 261000, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Wuhan, 430079, China
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Xi'an, 710004, China
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Xiangfan, 441021, China
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Xinxiang, 453100, China
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Xuzhou, 221002, China
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Xuzhou, 221009, China
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Zunyi, 563100, China
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Barranquilla, 080020, Colombia
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Bogotá, 110221, Colombia
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Cali, 760042, Colombia
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Medellín, 050030, Colombia
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Montería, 23001, Colombia
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Valledupar, 200001, Colombia
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Osijek, 31000, Croatia
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Rijeka, 51000, Croatia
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Split, 21000, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10000, Croatia
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Brno, 625 00, Czechia
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Hořovice, 26831, Czechia
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Liberec, 46063, Czechia
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Pardubice, 532 03, Czechia
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Prague, 150 06, Czechia
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Tallinn, 10138, Estonia
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Tallinn, 11619, Estonia
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Tartu, 50406, Estonia
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Angers, 49100, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Clermont-Ferrand, 63000, France
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Dijon, 21000, France
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Epagny Metz-Tessy, 74370, France
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Lille, 59000, France
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Lyon, 75004, France
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Marseille, 13273, France
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Montpellier, 34298, France
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Nantes, 44277, France
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Nîmes, 30029, France
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Paris, 75005, France
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Pierre-Bénite, 69495, France
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Plerin SUR MER, 22190, France
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Rennes, 35000, France
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Rouen, 76021, France
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Saint-Cloud, 92210, France
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Saint-Herblain, 44800, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67033, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54519, France
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Villejuif, 94805, France
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Batumi, 6000, Georgia
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Tbilisi, 0102, Georgia
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Tbilisi, 0112, Georgia
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Tbilisi, 0179, Georgia
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Tbilisi, 0186, Georgia
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Tbilisi, 114, Georgia
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Tbilisi, 160, Georgia
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Aachen, 52074, Germany
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Berlin, 12559, Germany
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Cologne, 51067, Germany
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Darmstadt, 64283, Germany
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Deggendorf, 94469, Germany
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Dessau, 6847, Germany
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Dresden, 01127, Germany
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Düsseldorf, 40235, Germany
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Essen, 45130, Germany
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Freudenstadt, 72250, Germany
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Georgsmarienhütte, 49124, Germany
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Hamburg, 20357, Germany
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Hamburg, 22457, Germany
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Hamm, 59073, Germany
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Hanau, 63450, Germany
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Hanover, 30177, Germany
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Hanover, 30559, Germany
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Heidelberg, 69120, Germany
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Karlsruhe, 76135, Germany
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Koblenz, 56068, Germany
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Mainz, 55131, Germany
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Nürtingen, 72622, Germany
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Offenburg, 77654, Germany
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Rostock, 18057, Germany
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Saarbrücken, 66113, Germany
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Schweinfurt, 97421, Germany
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Speyer, 67346, Germany
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Torgau, 4860, Germany
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Related Publications (1)
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.
PMID: 40017004DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2023
First Posted
July 19, 2023
Study Start
October 5, 2023
Primary Completion (Estimated)
March 4, 2030
Study Completion (Estimated)
May 6, 2037
Last Updated
June 19, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.