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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: carletonn2@upmc.edu
• Phone: 412-266-1991

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.