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A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Recruiting
I'm InterestedTrial ID: NCT05774951
Purpose
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.
Official Title
A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer
Stanford Investigator(s)
Melinda L. Telli, M.D.
Professor of Medicine (Oncology)
Eligibility
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 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
Intervention(s):
drug: Camizestrant
drug: Tamoxifen
drug: Anastrozole
drug: Letrozole
drug: Exemestane
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Vishaka Muhunthan
vmuhun@stanford.edu