Actively Recruiting
Active Surveillance in Older Women With ER+ Breast Cancer
Led by University of Pittsburgh · Updated on 2025-12-03
50
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Active Surveillance in Older Women With ER+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 70 years or older with invasive breast cancer who have not had surgery, systemic therapy, or radiation for this diagnosis
- Tumors detected through mammographic screening
- Tumor size 2 cm or smaller (T1a to T1c) with no clinical or radiographic lymph node involvement
- For tumors 1 cm or smaller (cT1a or cT1b), Nottingham Grade I or II allowed
- For tumors larger than 1 cm up to 2 cm (cT1c), only Nottingham Grade I allowed
- Breast cancer must be estrogen receptor positive (≥60% positive tumor nuclei) and HER2 negative per guidelines
- Patients with cognitive impairment may participate if a legal surrogate can provide consent
- Archival tissue must be available before joining the study
You will not qualify if you...
- Prior anticancer treatment (endocrine therapy, chemotherapy, radiation, or investigational therapy) for current breast cancer
- Current diagnosis considered a recurrence by the treating physician
- Multifocal or multicentric breast cancer
- History of contralateral ductal carcinoma in situ (DCIS) or ipsilateral/contralateral lobular carcinoma in situ (LCIS)
- History of any radiation therapy to the same breast
- Diagnosis of inflammatory breast cancer (T4d)
- Male breast cancer
- Severe uncontrolled medical conditions that pose safety risks or affect study compliance, such as severe gastrointestinal disease or severe liver impairment (Child-Pugh Class C)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
N
Neil Carleton, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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