RECRUITING

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

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 endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Official Title

CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

Quick Facts

Study Start:2023-03-31
Study Completion:2036-05-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05774951

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 high or intermediate risk of recurrence, based on clinical-pathological risk features, 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. * Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  6. * Adequate organ and 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 at 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
1-877-400-4655
az-bcsl@careboxhealth.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35205
United States
Research Site
Dothan, Alabama, 36303
United States
Research Site
Anchorage, Alaska, 99508
United States
Research Site
Chandler, Arizona, 85224
United States
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Hot Springs National Park, Arkansas, 71913
United States
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Anaheim, California, 92801
United States
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Beverly Hills, California, 90211
United States
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Concord, California, 94520
United States
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Corona, California, 92882
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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Los Alamitos, California, 90720
United States
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Palo Alto, California, 94304
United States
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San Diego, California, 92121
United States
Research Site
San Diego, California, 92123
United States
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Whittier, California, 90603
United States
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Aurora, Colorado, 80045
United States
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Hartford, Connecticut, 06102
United States
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Fort Myers, Florida, 33901
United States
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Gainesville, Florida, 32603
United States
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Miami Beach, Florida, 33140
United States
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Orlando, Florida, 32806
United States
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Plantation, Florida, 33324
United States
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Port Saint Lucie, Florida, 34952
United States
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Saint Augustine, Florida, 32086
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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Winter Haven, Florida, 33880
United States
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Atlanta, Georgia, 30310
United States
Research Site
Atlanta, Georgia, 30318
United States
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Columbus, Georgia, 31904
United States
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Honolulu, Hawaii, 96813
United States
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Chicago, Illinois, 60608
United States
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Chicago, Illinois, 60637
United States
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Decatur, Illinois, 62526
United States
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Elmhurst, Illinois, 60126
United States
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Hinsdale, Illinois, 60521
United States
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Park Ridge, Illinois, 60068
United States
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Fort Wayne, Indiana, 46804
United States
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Iowa City, Iowa, 52242
United States
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Fort Mitchell, Kentucky, 41017
United States
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Lexington, Kentucky, 40536
United States
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Louisville, Kentucky, 40202
United States
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Louisville, Kentucky, 40202
United States
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Baton Rouge, Louisiana, 70809
United States
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Brewer, Maine, 04412
United States
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Scarborough, Maine, 04074
United States
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Frederick, Maryland, 21702
United States
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Glenn Dale, Maryland, 20769
United States
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Silver Spring, Maryland, 20910
United States
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Towson, Maryland, 21204
United States
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Boston, Massachusetts, 02111
United States
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Hyannis, Massachusetts, 02601
United States
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Ann Arbor, Michigan, 48109
United States
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Detroit, Michigan, 48202
United States
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East Lansing, Michigan, 48824
United States
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Royal Oak, Michigan, 48073
United States
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Independence, Missouri, 64057
United States
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Lincoln, Nebraska, 68506
United States
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Las Vegas, Nevada, 89148
United States
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Laconia, New Hampshire, 03246
United States
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Belleville, New Jersey, 07109
United States
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Farmington, New Mexico, 87401
United States
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Santa Fe, New Mexico, 87505
United States
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Bronx, New York, 10461
United States
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East Syracuse, New York, 13057
United States
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New Hyde Park, New York, 11042
United States
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New York, New York, 10011
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, 27710-0001
United States
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Greensboro, North Carolina, 27403
United States
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Raleigh, North Carolina, 27607
United States
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Rocky Mount, North Carolina, 27804
United States
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Winston-Salem, North Carolina, 27103
United States
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Winston-Salem, North Carolina, 27104
United States
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Cincinnati, Ohio, 45219
United States
Research Site
Cincinnati, Ohio, 45255
United States
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Cleveland, Ohio, 44106
United States
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Cleveland, Ohio, 44195
United States
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Cleveland, Ohio, 44195
United States
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Youngstown, Ohio, 44504
United States
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Clairton, Pennsylvania, 15025
United States
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Philadelphia, Pennsylvania, 19106
United States
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Philadelphia, Pennsylvania, 19111
United States
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Pittsburgh, Pennsylvania, 15213
United States
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Reading, Pennsylvania, 19611
United States
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State College, Pennsylvania, 16803
United States
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Providence, Rhode Island, 02903
United States
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Lancaster, South Carolina, 29720
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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Mitchell, South Dakota, 57301
United States
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Pierre, South Dakota, 57501
United States
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Sioux Falls, South Dakota, 57105
United States
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Yankton, South Dakota, 57078
United States
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Chattanooga, Tennessee, 37404
United States
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Knoxville, Tennessee, 37920
United States
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Nashville, Tennessee, 37203
United States
Research Site
Nashville, Tennessee, 37204
United States
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Dallas, Texas, 75230
United States
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Denton, Texas, 76201
United States
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Houston, Texas, 77024
United States
Research Site
Houston, Texas, 77030
United States
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Irving, Texas, 75063
United States
Research Site
Ogden, Utah, 84405
United States
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Salt Lake City, Utah, 84106
United States
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Fairfax, Virginia, 22031
United States
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Lynchburg, Virginia, 24501
United States
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Midlothian, Virginia, 23114
United States
Research Site
Reston, Virginia, 20190
United States
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Richmond, Virginia, 23235
United States
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Seattle, Washington, 98101
United States
Research Site
Seattle, Washington, 98104
United States
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Spokane, Washington, 99202
United States
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Tacoma, Washington, 98405
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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Madison, Wisconsin, 53792
United States
Research Site
Milwaukee, Wisconsin, 53226
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 Date2023-03-31
Study Completion Date2036-05-29

Study Record Updates

Study Start Date2023-03-31
Study Completion Date2036-05-29

Terms related to this study

Keywords Provided by Researchers

  • ER+
  • HER2-
  • breast cancer

Additional Relevant MeSH Terms

  • Breast Cancer, Early Breast Cancer