Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in

The purpose of this research study is to see if camizestrant is safe and effective for the treatment of your condition. The researchers want to confirm the right dose levels of camizestrant and find out what effects (good and bad) camizestrant has on you and your condition. This study involves an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA).
We want to see if extended therapy with camizestrant is better at preventing disease recurrence (disease that comes back) than continuation of standard endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen, the drugs that you and other patients with early ER+/HER2- breast cancer are currently receiving) and also to better understand the studied disease and associated health problems.

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital 
8081 Innovation Park Drive
Fairfax, VA 22031

• Patient must be ≥18 years.
• Documented histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of advanced diseased.
• The patient must have undergone adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without adjuvant systemic therapy (chemotherapy and/or ET). Prior adjuvant treatment with olaparib in patients with germline BRCA1/2 mutations is allowed.
• The patient must have completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (regardless of missed doses) and is currently still receiving ET (ie, within the past 3 months). Patients who have received a (neo)adjuvant CDK4/6 inhibitor plus ET are eligible but must have completed the planned CDK4/6 inhibitor part of treatment.
• The patient has a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• The patient is able to swallow oral medications.

• Patients with inoperable locally advanced breast cancer, or distant metastatic (including contralateral axillary lymph nodes) disease.
• Patients with pathological complete response following treatment with neoadjuvant therapy.
• Patients with a 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), unless in complete remission with no therapy for a minimum of 5 years.
• Patients with a history of previous breast cancer are excluded with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago or contralateral DCIS treated with locoregional therapy at any time. Patients with DCIS (either ipsilateral or contralateral) treated with ET must have completed ET ≥5 years prior.
• Chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment.
• Previous treatment with camizestrant, investigational SERDs/investigational endocrine agents, or fulvestrant.

For more information, please visit:  https://clinicaltrials.gov/study/NCT05774951