A study to determine the safety and effectiveness of an investigational medicine called camizestrant compared to standard hormone therapy administered to prevent cancer return in people with early breast cancer who have recently had surgery and radiotherapy/chemotherapy and are free of cancer.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2024/03/064387
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
•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 investigators opinion precludes participation in the study or compliance.
•Known LVEF less than 50 percentage with heart failure NYHA Grade more than equal to 2.
•Mean resting QTcF interval more than 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 or 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 or peri menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Invasive breast cancer-free survival (IBCFS)Timepoint: Up to 14 years
- Secondary Outcome Measures
Name Time Method Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311Timepoint: Until 28 days after the final dose of study treatment (up to 7 years);Distant relapse-free survival (DRFS)Timepoint: Up to 14 years;Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)Timepoint: Until 28 days after the final dose of study treatment (up to 7 years);Invasive disease-free survival (IDFS)Timepoint: Up to 14 years;Overall survival (OS)Timepoint: Up to 14 years;Pharmacokinetics (PK)Timepoint: Until 6 months from treatment start;Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.Timepoint: Until 28 days after the final dose of study treatment (up to 7 years)