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

Recruiting · NCT05774951 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

Anastrozole Camizestrant Exemestane Letrozole Tamoxifen

What this trial is about

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.

Who can take part

Age range

18 Years to 130 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 39 US states.

Research Site - Birmingham, Alabama, United States
Research Site - Dothan, Alabama, United States
Research Site - Anchorage, Alaska, United States
Research Site - Chandler, Arizona, United States
Research Site - Hot Springs, Arkansas, United States
Research Site - Anaheim, California, United States
Research Site - Beverly Hills, California, United States
Research Site - Concord, California, United States
Research Site - Corona, California, United States
Research Site - Fountain Valley, California, United States
Research Site - Greenbrae, California, United States
Research Site - Los Alamitos, California, United States
Research Site - Palo Alto, California, United States
Research Site - San Diego, California, United States
Research Site - San Diego, California, United States
Research Site - Whittier, California, United States
Research Site - Aurora, Colorado, United States
Research Site - Hartford, Connecticut, United States
Research Site - Fort Myers, Florida, United States
Research Site - Gainesville, Florida, United States
Research Site - Miami Beach, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Plantation, Florida, United States
Research Site - Port Saint Lucie, Florida, United States
Research Site - Saint Augustine, Florida, United States
Research Site - St. Petersburg, Florida, United States
Research Site - St. Petersburg, Florida, United States
Research Site - Tallahassee, Florida, United States
Research Site - West Palm Beach, Florida, United States
Research Site - Winter Haven, Florida, United States
Research Site - Atlanta, Georgia, United States
Research Site - Atlanta, Georgia, United States
Research Site - Columbus, Georgia, United States
Research Site - Honolulu, Hawaii, United States
Research Site - Chicago, Illinois, United States
Research Site - Chicago, Illinois, United States
Research Site - Decatur, Illinois, United States
Research Site - Elmhurst, Illinois, United States
Research Site - Hinsdale, Illinois, United States
Research Site - Park Ridge, Illinois, United States
Research Site - Park Ridge, Illinois, United States
Research Site - Fort Wayne, Indiana, United States
Research Site - Iowa City, Iowa, United States
Research Site - Fort Mitchell, Kentucky, United States
Research Site - Lexington, Kentucky, United States
Research Site - Louisville, Kentucky, United States
Research Site - Baton Rouge, Louisiana, United States
Research Site - Brewer, Maine, United States
Research Site - Scarborough, Maine, United States
Research Site - Frederick, Maryland, United States
Research Site - Glenn Dale, Maryland, United States
Research Site - Silver Spring, Maryland, United States
Research Site - Towson, Maryland, United States
Research Site - Boston, Massachusetts, United States
Research Site - Hyannis, Massachusetts, United States
Research Site - Ann Arbor, Michigan, United States
Research Site - Detroit, Michigan, United States
Research Site - East Lansing, Michigan, United States
Research Site - Lansing, Michigan, United States
Research Site - Royal Oak, Michigan, United States

Showing 60 of 709 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →