General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT05952557

Background Information

The purpose of this study is to measure the safety and demonstrate the superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib of patients with ER+/HER2- early breast cancer.

For more information, visit: https://clinicaltrials.gov/study/NCT05952557

Offered At

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

Lauren Mauro, MD

Eligibility Information

  • Patient must be ≥18 years at the time of screening
  • Documented histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease. ER and HER2 measurement should be performed under institutional guidelines
  • Pre-, peri-, and post-menopausal women, and men are eligible if they meet at least 1 of
    the criteria listed in the protocol
  • Patients must have undergone adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s) with or without (neo) adjuvant systemic chemotherapy.
  • Additional eligibility in protocol

Ineligibility Information

  • Patients with inoperable locally advanced breast cancer, without known distant metastasis or distant metastatic (including contralateral axillary lymph nodes) disease.
  • Patients with pathological complete response (pCR; ypT0/ypTis ypN0) or residual cancer
    burden (RCB)-0 following treatment with neoadjuvant chemotherapy.
  • Patients with a history of previous invasive breast cancer are excluded.
  • Major surgical procedure or significant traumatic injury within 2 weeks of randomisation.
  • Additional ineligibility in protocol