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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Research Site, Dothan, Alabama, United States
• Research Site, Phoenix, Arizona, United States
• Research Site, Tucson, Arizona, United States
• Research Site, Fayetteville, Arkansas, United States
• Research Site, Duarte, California, United States
• Research Site, Fountain Valley, California, United States
• Research Site, Greenbrae, California, United States
• Research Site, Irvine, California, United States
• Research Site, La Jolla, California, United States
• Research Site, Los Angeles, California, United States
• Research Site, Monterey, California, United States
• Research Site, Walnut Creek, California, United States

+ 786 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05952557.