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Active Surveillance in Older Women With ER+ Breast Cancer
Sponsor: University of Pittsburgh
Summary
ACTIVE is a prospective, single-arm, phase I/IIa study examining an active surveillance strategy for small, screen-detected, luminal breast cancer. Patients aged 70 or older with clinical stage I ER+/HER2- breast cancer are eligible. The goal of this clinical trial is to learn if an active surveillance strategy (serial imaging rather than therapeutic intervention) is a safe approach to monitor small breast cancers. The main question to answer is the proportion of participants who experience tumor progression by 12 months.
Official title: Protocol-Directed Active Surveillance for Older Women With Small, Screen-Detected, ER+/HER2- Breast Cancer
Key Details
Gender
FEMALE
Age Range
70 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-11-01
Completion Date
2030-12-31
Last Updated
2025-12-03
Healthy Volunteers
No
Interventions
Active Surveillance
Active surveillance is achieved through serial breast and axillary ultrasound. This will occur in the absence of any concurrent treatment of the breast cancer with the goal of identifying if the tumor grows after 12 months of observation. Patients will undergo ultrasound at diagnosis, 6 months, and 12 months. They may receive optional ultrasounds at 3 months and 9 months. If patients do not experience a progression during the allotted study period, but decline to continue with active surveillance, they may undergo any local or systemic therapy at the discretion of their local treating oncologist. If the tumor reaches the pre-specified threshold for progression at the time of the protocol-directed imaging, patients will undergo standard of care breast cancer therapy. The type and extent of surgery, adjuvant and systemic therapy will be left to the local treating team.
Locations (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States