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Radiation-Free path for young breast cancer patients? trial tests skipping therapy

NCT ID NCT07762924

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial is testing whether young women under 40 with a very early, low-risk form of breast cancer called ductal carcinoma in situ (DCIS) can safely avoid radiation therapy after having breast-conserving surgery. Instead of radiation, participants will be closely monitored, and some may take hormone-blocking medication. The study will track how many women experience a recurrence in the same breast over five years to see if skipping radiation is a safe option.

What this could mean

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

Active substance
Omission of adjuvant radiotherapy, with close surveillance and optional endocrine therapy
What this could lead to
If successful, this could show that some young women with low-risk DCIS can safely skip radiation, avoiding side effects and reducing treatment burden.
What could go wrong
This is a phase II trial, so results are preliminary. Skipping radiation may increase the risk of breast cancer recurrence, and the long-term safety is not yet established.

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

About 234 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2037

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

Up to 40 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 \<40 years； 2. Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions； 3. Tumor size ≤1 cm on final pathology； 4. Negative surgical margins ≥3 mm, including margins obtained after re-excision； 5. Unifocal lesion； 6. Absence of comedo necrosis； 7. Screen-detected disease without bloody nipple discharge or palpable mass； 8. Clinically node-negative disease； 9. Central pathology review by the participating institution required； 10. Ability to understand and willingness to sign written informed consent. Exclusion Criteria: 1. Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory)； 2. Bilateral breast cancer or prior contralateral breast cancer； 3. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders； 4. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ； 5. Pregnant or breastfeeding patients； 6. Estimated life expectancy ≤5 years； 7. Poor compliance or inability to adhere to study follow-up requirements.

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Conditions

The condition(s) this trial relates to.

ductal breast carcinoma in situ

As listed by the trial registrant

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

Ductal carcinoma in situ, dcis

How to take part

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

  1. The places running it

    1 site. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

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