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

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05952557
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AstraZeneca
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Early Breast Cancer

Additional Details

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 of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Arms & Interventions

Arms

Active Comparator: Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib

standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib

Experimental: Arm B: camizestrant ± abemaciclib

camizestrant ± abemaciclib

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Fayetteville, Arkansas

Status

Recruiting

Address

Research Site

Fayetteville, Arkansas, 72703

Site Contact

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