Active Surveillance in Older Women With ER+ Breast Cancer
Protocol-Directed Active Surveillance for Older Women With Small, Screen-Detected, ER+/HER2- Breast Cancer
University of Pittsburgh
50 participants
Nov 1, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- Women aged 70 years or older with a diagnosis of invasive breast cancer who have not undergone surgical resection of the primary invasive tumor and/or axillary lymph nodes, have not undertaken any systemic therapy, and have not received radiation therapy as a treatment for this diagnosis. Patients with invasive cancer that is identified after excisional biopsy for atypia are included.
- Tumors must have been identified through mammographic screening.
- cT1a or cT1b (≤ 1cm): Nottingham Grade I or II allowed entry.
- cT1c (\>1-2cm): only Nottingham Grade I allowed entry.
- Breast cancer must be ER positive and HER2 negative according to the definition below, as assessed by local pathology.
- ER is considered positive if there are ≥ 60% positive tumor nuclei in the samples.
- HER2 negativity is defined per the current ASCO/CAP Clinical Practice Guideline.
- Patients with cognitive impairment are eligible provided that a legal surrogate is able to sign informed consent for study participation.
- Archival tissue will be submitted for all participants. Tissue must be confirmed available prior to registration.
Exclusion Criteria7
- Prior anti-cancer therapy (e.g., endocrine therapy, chemotherapy, radiation therapy, or investigational therapy) for the current breast cancer diagnosis.
- Current breast cancer diagnosis that is deemed a recurrence, at the discretion of the treating investigator.
- Multifocal or multicentric disease.
- Patients with a history of contralateral DCIS, or ipsilateral or contralateral LCIS are not eligible. Patients with a history of any ipsilateral breast radiation are not eligible.
- Diagnosis of inflammatory breast cancer (T4d).
- Male breast cancer.
- Any concurrent severe and uncontrolled medical condition that, in the treating clinician's opinion, would pose unacceptable safety risks or compromise compliance with the protocol. Such conditions could include: impairment of gastrointestinal tract function or gastrointestinal disease that may significantly alter the absorption of oral medications (uncontrolled Crohn disease or ulcerative colitis, uncontrolled chronic nausea, vomiting diarrhea, malabsorption, or small bowel resection); severe liver impairment (Child-Pugh Class C).
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07262138