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ACTIVE NOT RECRUITING

NCT05952557

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

5511

Start Date

2023-10-05

Completion Date

2037-05-06

Last Updated

2026-08-10

Healthy Volunteers

Conditions

Breast Cancer, Early Breast Cancer

Interventions

DRUG

Camizestrant

Camizestrant. Experimental. Administered orally

DRUG

Tamoxifen

Tamoxifen. Comparator. Administered orally

DRUG

Anastrozole

Anastrozole. Comparator. Administered orally

DRUG

Letrozole

Letrozole. Comparator. Administered orally

DRUG

Exemestane

Exemestane. Comparator. Administered orally

DRUG

Abemaciclib

Abemaciclib adjuvant treatment Administered orally

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 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 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 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.

Locations (661)

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Dothan, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Fayetteville, Arkansas, United States

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Duarte, California, United States

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Fountain Valley, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Walnut Creek, California, United States

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West Hollywood, California, United States

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Aurora, Colorado, United States

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Littleton, Colorado, United States

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Littleton, Colorado, United States

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New Haven, Connecticut, United States

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Newark, Delaware, United States

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Clearwater, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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Plantation, 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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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Thomasville, Georgia, United States

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Chicago, Illinois, United States

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Elmhurst, Illinois, United States

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Naperville, Illinois, United States

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Urbana, Illinois, United States

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Fort Wayne, Indiana, United States

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Des Moines, Iowa, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Scarborough, Maine, United States

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Annapolis, Maryland, United States

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Bethesda, Maryland, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Hooksett, New Hampshire, United States

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Manchester, New Hampshire, United States

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New Brunswick, New Jersey, United States

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Albuquerque, New Mexico, United States

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Farmington, New Mexico, United States

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Bay Shore, New York, United States

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East Syracuse, New York, United States

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Greenlawn, New York, United States

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New Hyde Park, 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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Stony Brook, New York, United States

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White Plains, New York, United States

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Charlotte, North Carolina, United States

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Pinehurst, North Carolina, United States

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Raleigh, 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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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Gettysburg, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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York, Pennsylvania, United States

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Charleston, South Carolina, United States

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Rock Hill, 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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Sioux Falls, South Dakota, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Flower Mound, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Charlottesville, Virginia, United States

And 561 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (661)