NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not 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 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.

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 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)

Dothan, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Duarte, California, United States
Fountain Valley, California, United States
Irvine, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Walnut Creek, California, United States
West Hollywood, California, United States
Aurora, Colorado, United States
Littleton, Colorado, United States
Littleton, Colorado, United States
New Haven, Connecticut, United States
Newark, Delaware, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Plantation, Florida, United States
St. Petersburg, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Thomasville, Georgia, United States
+ 631 more on CT.gov