CAMBRIA-1: A 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 Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

Location: Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

Purpose:

We are doing this study to learn more about an experimental drug called camizestrant. Experimental means it hasn’t been fully tested and it is not approved by any health authority, such as the US Food and Drug Administration, except for use in research studies like this.

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). We also want to better understand the studied disease and associated health problems.

Sponsor: AstraZeneca

https://clinicaltrials.gov/ct2/show/NCT05774951

Eligibility:

• Must have confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of advanced disease.
• Pre-, peri-, and post-menopausal women, and men, with at least one of the following:
  • (a) T4 tumors regardless of nodal status.
  • (b) Primary invasive tumor size >5 cm regardless of nodal status.
  • (c) Tumor of any size with involvement in ≥2 lymph nodes on same side as tumor.  No involvement of lymph nodes on side opposite the tumor.
  • (d) Primary invasive tumor size >1 cm and ≤5 cm or only micrometastatic disease under certain conditions
• Must have undergone adequate surgery, with or without radiotherapy, for the primary breast tumor(s), with or without following chemotherapy and/or ET.
• 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).
• Must not have inoperable locally advanced breast cancer or distant metastatic disease.
• Must not have had a complete response following treatment with neoadjuvant therapy.

Time Commitment: Up to 13 years