Recruiting

Active Surveillance

Sponsor:

University of Pittsburgh

Code:

NCT07262138

Conditions

Early Stage Estrogen Receptor (ER) Positive Breast Cancer

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Active Surveillance

Study Details

Brief 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.

Conditions

Early Stage Estrogen Receptor (ER) Positive Breast Cancer

Study ID

NCT07262138

Start date

Nov 1, 2025

Status verified date

Sep, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Tumor is less than or equal to 2cm (T1a through T1c) in maximum dimension based on diagnostic ultrasound, or if not visible on ultrasound, then on mammogram. Must have clinically and radiographically node negative disease. Inclusion criteria for different tumor sizes is as follows:

  • 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 Criteria:

  • 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).

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Neil Carleton, MD, PhD

412-266-1991carletonn2@upmc.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Neil Carleton, MD, PhD

412-266-1991carletonn2@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Early stage breast cancer
  • Stage I breast cancer
  • Estrogen receptor positive breast cancer
  • Breast cancer in older women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.