Could Pre-Surgery radiation shrink breast tumors?

NCT ID NCT03359954

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This phase II trial studies whether giving radiation therapy before surgery can shrink hormone receptor-positive, HER2-negative breast tumors. About 25 participants will receive radiation followed by breast surgery. The goal is to see if this approach reduces the amount of normal tissue that needs to be removed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: radiation therapy
What this could lead to: If successful, this approach could make breast cancer surgery less extensive by shrinking tumors beforehand.
What could go wrong: This is a small, early-phase trial with only 25 participants, so results may not apply broadly. There is also a risk of surgery delays due to radiation.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

Nov 2017

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion: * Age \>/=18 years at time of study entry * Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast * Presence of a clip in the primary breast cancer * Biopsy-amenable residual disease in the breast measuring \>/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Signed written informed consent * Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon. Exclusion: * Women who are pregnant or breast-feeding * Contraindication to receive radiotherapy

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Estrogen receptor positive are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Her2-receptor negative breast cancer hormone receptor-positive breast cancer invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Estrogen receptor positive HER2/neu negative Invasive breast carcinoma Progesterone receptor positive

Could Pre-Surgery radiation shrink breast tumors?

What the study statuses mean