Active Surveillance in Older Women With ER+ Breast Cancer

Conditions

• Early Stage Estrogen Receptor (ER) Positive Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Active Surveillance — OTHER
  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.

Study Details

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.

Key Dates

Start date

Nov 1, 2025

Status verified

Nov 2025

Primary completion

Nov 1, 2028

Completion

Dec 31, 2030

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Active surveillance group
  Following diagnosis, patients enroll in the study and complete imaging assessments at 6 months and 12 months via breast and axillary ultrasound. Patients may opt to undergo additional ultrasound imaging of the breast and axillary at the 3 and 9 month marks. These timepoints are optional. If, at any point during the study, patients experience new breast symptoms such as pain, palpable mass in breast or axilla, rash/nodule to the skin of the breast, patients are encouraged to notify their local treating oncologist. Additional imaging outside of the protocol-directed schedule is allowable at the discretion of the local treating oncologist.

Primary Outcome Measure

12 month rate of tumor progression [ Time Frame: 12 months ]

Central Contacts

• Neil Carleton, MD, PhD
  412-266-1991
  [email protected]

Locations (1)

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