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Could a gene test spare some breast cancer patients from radiation?

NCT ID NCT02653755

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

The PRECISION trial is studying whether women with a specific type of early-stage breast cancer can safely avoid radiation therapy after having a lumpectomy. Participants have tumors that are small, hormone receptor-positive, HER2-negative, and low-grade. A gene test called Prosigna helps identify those at very low risk of recurrence. The goal is to see if the cancer returns in the same breast within five years without radiation. This research could help personalize treatment and spare some women from unnecessary side effects.

What this could mean

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

Active substance
Prosigna (PAM-50) gene test
What this could lead to
If successful, this could show that some women with early-stage, low-risk breast cancer can avoid radiotherapy after lumpectomy, reducing side effects and treatment burden.
What could go wrong
This is a phase 2 study, so results are preliminary. It's possible that skipping radiotherapy may lead to a higher risk of cancer returning in the breast, and the findings may not apply to all patients.

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

671 people

The number who actually took part.

Started

Dec 2015

Expected to finish

May 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

50 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: * Histologically confirmed invasive breast cancer * The primary tumor must be excised via breast conserving surgery ("lumpectomy") with negative margins ("no ink on tumor") or re-excision showing no residual disease in the re-excision specimen. * The tumor must be ≤2 cm (T1) in the largest dimension. * Immunohistochemical studies must demonstrate the tumor to be ER+ (≥10%) or PR+, HER2- and grade 1 or 2. * The patient must have undergone either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) demonstrating pathologic node-negativity (pN0). However, patients with immunohistochemical evidence of isolated tumor cells in a lymph node \[pN0(i+)\] are eligible if no deposit \>0.2mm is identified. * Age: this study is open to patients between 50 and 75 years of age (inclusive). Patients younger than 50 years of age are excluded based on prior data suggesting a different natural history for breast cancers arising in premenopausal women (with different subtype and biologic distributions that may confound the current aims). Women older than 75 years of age are excluded from this protocol due to historical difficulties achieving robust follow-up in this population, along with competing comorbidities which have been shown to interfere with subsequent breast cancer monitoring and evaluation. * ECOG performance status ≤2 (Karnofsky ≥60%) * Life expectancy of \>5 years per the clinical impression of the treating physician(s). * Eligible for and willing to undergo a course of adjuvant endocrine therapy. Exclusion Criteria: * At the time of enrollment, subjects may not have had any prior systemic therapy for breast cancer, including chemotherapy, hormonal therapy or targeted biologic therapy. Similarly, chemotherapy or biologic therapy must not be part of the subsequent treatment plan. * Clinical, radiographic or pathologic evidence of multicentric disease. * Evidence of T4 disease (e.g., involvement of the chest wall, skin, dermal lymphatics, or inflammatory breast cancer). * Grade 3 histology. * Tumors in which the invasive component is present only as micro-invasion. * Multicentric invasive or in site carcinoma * Bilateral breast malignancy. * Inability or unwillingness to tolerate endocrine therapy. * Documented mutation of TP53, BRCA1, BRCA2, or other hereditary cancer syndromes. * Significant comorbidity associated with an estimation of \<5 remaining life years. * Another diagnosis of malignancy within the 5 years preceding enrollment (excluding non-melanoma skin cancers or in situ cervical lesions, which are permitted). * Inability to understand or provide informed consent. * Current addictive or psychiatric disorder which may preclude protocol adherence. * Prior breast or chest radiotherapy for any indication. * Pregnant or lactating.

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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.

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloane Kettering Cancer Center

    New York, New York, 10065, United States

  • NYU Langone Health

    New York, New York, 10016, United States

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