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Precision radiotherapy targets rare breast tumors by genetic fingerprint

NCT ID NCT07657169

Disease control Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial investigates whether giving radiotherapy after surgery can prevent local recurrence in people with a rare breast tumor called phyllodes tumor, specifically those with high-risk molecular subtypes (MN1 or MN2). Participants who have had complete tumor removal will be randomly assigned to receive radiotherapy or just observation. The study aims to see if this personalized approach improves local control and safety.

What this could mean

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

Active substance
Postoperative radiotherapy (radiation therapy)
What this could lead to
If successful, this could establish a precision radiotherapy approach for high-risk phyllodes tumors, reducing local recurrence and improving outcomes.
What could go wrong
This is a mid-stage trial with 160 participants, so results may not apply broadly. Radiotherapy carries risks of skin irritation, fatigue, and rare long-term side effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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 to 75 years

Sex

Female participants only

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: 1. Female patients aged ≥18 years and ≤75 years. 2. Histologically confirmed breast phyllodes tumor (PT) by the central laboratory, with molecular classification as MN1 or MN2 subtype via transcriptome sequencing or IHC; 3. Primary or ipsilateral local recurrence following R0 resection (negative margins) before enrollment; 4. Pathologically confirmed borderline or malignant PT; 5. No evidence of distant metastasis (M0); 6. ECOG performance status 0-1; 7. Signed informed consent before treatment; 8. Expected randomization and study entry within 8-12 weeks (no later than 16 weeks) after surgery. Exclusion Criteria: 1. Previous radiation to the same-side breast or chest; 2. women, or those of childbearing potential refusing effective contraception; Pregnancy, lactation, or refusal of contraception by fertile subjects; 3. Grade III-IV bone marrow suppression: WBC≤1.9\*109/L，ANC≤0.9\*109/L，PLT≤49\*109/L，AST, ALT≥2\*ULN; 4. Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF \< 50%; 5. Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF \< 50%; 6. Prior or planned systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, or investigational agents) during the study; 7. Participation in other clinical trials that precludes study inclusion; 8. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for the trial.

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Conditions

The condition(s) this trial relates to.

breast phyllodes tumor malignant breast phyllodes tumor phyllodes tumor

As listed by the trial registrant

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

Molecular typing Phyllodes breast tumor Prognosis Radiotherapy, adjuvant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000, China

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003, China

  • The Second Hospital of Shandong University

    Jinan, Shandong, 250033, China

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