Could watching and waiting replace surgery for some breast cancers?
NCT ID NCT07262138
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study is testing whether it is safe for women aged 70 and older with small, screen-detected, ER+/HER2- breast cancers to simply monitor the tumor with regular ultrasounds instead of undergoing immediate treatment like surgery or radiation. The main goal is to see how many tumors grow within 12 months. The study involves 50 participants and uses serial imaging to track any changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could show that active monitoring is a safe option for older women with small, low-risk breast cancers, potentially avoiding unnecessary treatments.
- What could go wrong
- This is a very early, small study (50 participants) with no control group. It only tracks tumors for 12 months, so long-term safety is unknown. Some tumors may grow during monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients aged 70 or older with clinical stage I ER+/HER2- breast cancer
- Ages
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70 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213, United States