RECRUITING

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 within the study will be 7 years.

Official 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

Quick Facts

Study Start:2023-10-05
Study Completion:2037-05-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05952557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women and Men; ≥18 years at the time of screening (or per national guidelines)
  2. * Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
  3. * Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
  4. * Patients must be randomised within 12 months of definitive breast surgery.
  5. * Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  7. * Adequate organ and bone marrow function
  1. * Inoperable locally advanced or metastatic breast cancer
  2. * Pathological complete response following treatment with neoadjuvant therapy
  3. * 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
  4. * Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
  5. * Known LVEF \<50% with heart failure NYHA Grade ≥2.
  6. * Mean resting QTcF interval \> 480 ms at screening
  7. * Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
  8. * Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
  9. * Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
  10. * Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
  11. * 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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com
AstraZeneca Breast Cancer Study Locator Service
CONTACT
1-877-400-4656
az-bcsl@careboxhealth.com

Study Locations (Sites)

Research Site
Dothan, Alabama, 36303
United States
Research Site
Phoenix, Arizona, 85054
United States
Research Site
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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Newark, Delaware, 19713
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
Research Site
Plantation, Florida, 33324
United States
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Saint Petersburg, Florida, 33705
United States
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Saint 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
Research Site
Baltimore, Maryland, 21287
United States
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Bethesda, Maryland, 20817
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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Saint Louis, Missouri, 63110
United States
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Saint 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
Research Site
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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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
Research Site
Rock Hill, South Carolina, 29732
United States
Research Site
Spartanburg, South Carolina, 29303
United States
Research Site
Aberdeen, South Dakota, 57401
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Knoxville, Tennessee, 37909
United States
Research Site
Knoxville, Tennessee, 37920
United States
Research Site
Memphis, Tennessee, 38120
United States
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Nashville, Tennessee, 37203
United States
Research Site
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
Research Site
Dallas, Texas, 75231
United States
Research Site
Dallas, Texas, 75246
United States
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El Paso, Texas, 79902
United States
Research Site
Flower Mound, Texas, 75028
United States
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Houston, Texas, 77024
United States
Research Site
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
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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
Research Site
Winchester, Virginia, 22601
United States
Research Site
Puyallup, Washington, 98373
United States
Research Site
Spokane, Washington, 99202
United States
Research Site
Vancouver, Washington, 98684
United States
Research Site
Charleston, West Virginia, 25304
United States
Research Site
Morgantown, West Virginia, 26505
United States
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Appleton, Wisconsin, 54911
United States
Research Site
Madison, Wisconsin, 53792
United States
Research Site
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-05
Study Completion Date2037-05-06

Study Record Updates

Study Start Date2023-10-05
Study Completion Date2037-05-06

Terms related to this study

Keywords Provided by Researchers

  • ER+
  • HER2-
  • breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer, Early Breast Cancer