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RECRUITING

NCT05774951

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

4300

Start Date

2023-03-31

Completion Date

2036-05-29

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Breast Cancer, Early Breast Cancer

Interventions

DRUG

Camizestrant

Camizestrant. Experimental. Administered orally

DRUG

Tamoxifen

Tamoxifen. Comparator. Administered per local approved label

DRUG

Anastrozole

Anastrozole. Comparator. Administered per local approved label

DRUG

Letrozole

Letrozole. Comparator. Administered per local approved label

DRUG

Exemestane

Exemestane. Comparator. Administered per local approved label

Inclusion Criteria: * 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 high or intermediate risk of recurrence, based on clinical-pathological risk features, 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 * Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor) * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Adequate organ and marrow function Exclusion criteria: * 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 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 * 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 sex hormone therapy * 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

Locations (709)

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Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Anchorage, Alaska, United States

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Chandler, Arizona, United States

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Hot Springs, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Concord, California, United States

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Corona, California, United States

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Fountain Valley, California, United States

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Greenbrae, California, United States

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Los Alamitos, California, United States

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Palo Alto, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Whittier, California, United States

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Aurora, Colorado, United States

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Hartford, Connecticut, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Port Saint Lucie, Florida, United States

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Saint Augustine, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

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Winter Haven, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Park Ridge, Illinois, United States

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Fort Wayne, Indiana, United States

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Iowa City, Iowa, United States

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Fort Mitchell, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Brewer, Maine, United States

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Scarborough, Maine, United States

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Frederick, Maryland, United States

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Glenn Dale, Maryland, United States

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Hyannis, Massachusetts, United States

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Detroit, Michigan, United States

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East Lansing, Michigan, United States

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Lansing, Michigan, United States

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Royal Oak, Michigan, United States

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Independence, Missouri, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Laconia, New Hampshire, United States

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Belleville, New Jersey, United States

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Farmington, New Mexico, United States

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Santa Fe, New Mexico, United States

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East Syracuse, New York, United States

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New York, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Youngstown, Ohio, United States

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Clairton, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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State College, Pennsylvania, United States

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Providence, Rhode Island, United States

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Lancaster, South Carolina, United States

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Spartanburg, South Carolina, United States

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Aberdeen, South Dakota, United States

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Mitchell, South Dakota, United States

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Pierre, South Dakota, United States

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Sioux Falls, South Dakota, United States

And 609 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (709)