Active surveillance for small ER+ breast cancer in women 70 and older

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

This project will try active surveillance — regular imaging instead of immediate surgery or therapy — for women 70 and older with small, screen-detected ER+/HER2- breast cancers to see how many tumors grow within 12 months.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 70 Years and up
• Sex: Female
• Sponsor: University of Pittsburgh (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT07262138 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm phase I/IIa study enrolling women aged 70 or older with screen-detected, node-negative, ER+/HER2- invasive breast cancers up to 2 cm. Eligible tumors must meet size and grade cutoffs (T1a/b any grade I–II, T1c grade I) and participants have not received surgery, radiation, or systemic therapy for the index lesion. Instead of immediate treatment, patients undergo serial imaging and clinical follow-up to monitor for radiographic or clinical progression. The primary outcome is the proportion of participants who experience tumor progression by 12 months, with the goal of determining whether surveillance can safely reduce overtreatment in this population.

Who should consider this trial

Good fit: Women aged 70 years or older with screen-detected, clinically and radiographically node-negative invasive ER+/HER2- breast cancer ≤2 cm who meet the specified Nottingham grade criteria and have not yet received surgery, systemic therapy, or radiation.

Not a fit: Patients with tumors >2 cm, node-positive disease, HER2-positive or ER-negative cancers, higher-grade T1c tumors, symptomatic tumors, or those who prefer definitive treatment are unlikely to benefit from an active surveillance approach.

Why it matters

Potential benefit: If successful, this approach could let some older women avoid or delay surgery, radiation, and endocrine therapy, reducing treatment-related harms and preserving quality of life.

How similar studies have performed: Active surveillance for small invasive ER+ breast cancer in older women is relatively novel; there are limited pilot and observational data suggesting feasibility but no large randomized evidence yet.

Eligibility criteria

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).

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Priscilla F McAuliffe, MD, PhD — University of Pittsburgh
• Study coordinator: Neil Carleton, MD, PhD

Conditions Early Stage Estrogen Receptor Positive Breast Cancer; Early stage breast cancer; Stage I breast cancer; Estrogen receptor positive breast cancer; Breast cancer in older women