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

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Breast Cancer, Early Breast Cancer

Interventions: Camizestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Birmingham, Alabama, United States
Dothan, Alabama, United States
Anchorage, Alaska, United States
Chandler, Arizona, United States
Hot Springs, Arkansas, United States
Anaheim, California, United States
Beverly Hills, California, United States
Concord, California, United States
Corona, California, United States
Fountain Valley, California, United States
Greenbrae, California, United States
Los Alamitos, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Diego, California, United States
Whittier, California, United States
Aurora, Colorado, United States
Hartford, Connecticut, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Port Saint Lucie, Florida, United States
Saint Augustine, Florida, United States
St. Petersburg, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
West Palm Beach, Florida, United States
Winter Haven, Florida, United States
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