RecruitingNCT07262138

Active Surveillance in Older Women With ER+ Breast Cancer

Protocol-Directed Active Surveillance for Older Women With Small, Screen-Detected, ER+/HER2- Breast Cancer

Sponsor

University of Pittsburgh

Enrollment

50 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

Early Stage Estrogen Receptor (ER) Positive Breast Cancer

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

Sex: FEMALEMin Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether older women with a specific type of early-stage breast cancer can safely choose active surveillance (watchful monitoring with hormonal therapy) instead of surgery, given that surgery carries risks in older patients and many of these cancers grow very slowly. **You may be eligible if...** - You are a woman aged 70 or older - You have a diagnosis of invasive breast cancer detected through mammography screening - Your tumor is small (less than 2 cm) and has not had surgery yet - Your tumor is estrogen receptor positive (ER+) - You have not received any systemic therapy or radiation for this diagnosis **You may NOT be eligible if...** - You are younger than 70 - Your cancer has already been surgically removed - Your tumor is larger than 2 cm or has spread to lymph nodes - Your cancer is ER-negative or HER2-positive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERActive 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

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NCT07262138