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Could 3 weeks of radiation be as good as 5 for breast cancer?

NCT ID NCT02912312

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study compares a 3-week course of radiation to the standard 5-week course for breast cancer patients who need radiation to the lymph nodes. The goal is to see if the shorter schedule is just as effective at preventing cancer from coming back, while causing less arm swelling and other side effects. About 800 participants are being followed to track outcomes.

What this could mean

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

Active substance
Hypofractionated radiation therapy (shorter course of radiation)
What this could lead to
If it works, this could offer a shorter, more convenient radiation schedule for breast cancer patients, reducing arm swelling and other side effects.
What could go wrong
This is a Phase 2 trial, so results are still preliminary. The shorter schedule may not be as effective at preventing cancer recurrence, and side effects could differ.

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

805 people

The number who actually took part.

Started

Feb 2017

Expected to finish

Feb 2031

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

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, if receiving postoperative radiation therapy * Radiation oncologist recommends radiation treatment to the supraclavicular and infraclavicular fossa (i.e. RNI). * Pathologically-confirmed invasive breast cancer. If patients undergo upfront surgery, the pathologic stage must be T0-T3, N0-N2a or N3a. If patients receive neoadjuvant chemotherapy prior to surgery, the clinical stage must be T0-T3, N0-N2a or N3a. T4b disease is permitted if the patient undergoes breast conserving surgery. * Treatment with mastectomy or segmental mastectomy and axillary evaluation (sentinel node evaluation, axillary sampling, or axillary lymph node dissection). If the patient has T0 disease, breast surgery is not required. * Age 18 years or older. * If enrolling on in the arm lymphedema assessment cohort, documentation of arm volume measurement by perometer prior to axillary surgery. * If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer. * Patients must be enrolled on the trial within 24 weeks of the later of two dates: the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy. If after trial enrollment it is determined the patient requires additional cytotoxic chemotherapy or additional breast cancer surgery prior to radiation therapy the patient may stay on trial but the patient must start radiation therapy within 24 weeks of the final breast cancer surgical procedure or administration of the last cycle of cytotoxic chemotherapy. Inclusion Criteria, if receiving preoperative radiation therapy * Surgeon and radiation oncologist recommend preoperative radiation therapy * Radiation oncologist recommends radiation treatment to the supraclavicular and infraclavicular fossa (i.e. RNI). * Pathologically-confirmed invasive breast cancer. The clinical stage must be T0-T3, N0-N3b * Planned treatment with mastectomy and axillary evaluation (sentinel node evaluation, axillary sampling, or axillary lymph node dissection). * Planned breast reconstruction with autologous reconstruction. * Age 18 years or older. * If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer. Exclusion Criteria, if receiving postoperative radiation therapy * Pathologic or clinical evidence for a stage T4 breast cancer. However, T4b disease is permitted if the patient undergoes breast conserving surgery. * Pathologic or clinical evidence for a stage N2b, N3b, or N3c breast cancer (supraclavicular, or internal mammary lymph node involvement). * Clinical or pathologic evidence for distant metastases. * Current diagnosis of invasive breast cancer in the contralateral breast (ductal carcinoma in situ is permitted). * Prior diagnosis of invasive breast cancer in the contralateral breast. * If enrolling on in the arm lymphedema assessment cohort, current diagnosis of bilateral breast cancer. * History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast. Except those patients enrolled and treated on the PRECISE trial (MD Anderson 2017-0362). * Patient is pregnant. * Patients who are cognitively impaired. Subjects will undergo a brief physical exam including a brief exam to determine cognitive review. Exclusion Criteria, if receiving preoperative radiation therapy * Pathologic or clinical evidence for a stage T4 breast cancer. * Pathologic or clinical evidence for a stage N3c breast cancer (supraclavicular lymph node involvement). * Clinical or pathologic evidence for distant metastases. * Current diagnosis of invasive breast cancer in the contralateral breast (ductal carcinoma in situ is permitted). * Prior diagnosis of invasive breast cancer in the contralateral breast. * History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast. Except those patients enrolled and treated on the PRECISE trial (MD Anderson 2017-0362). * Patient is pregnant. * Patients who are cognitively impaired. Subjects will undergo a brief physical exam including a brief exam to determine cognitive review.

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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

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Community MD Anderson Cancer Center East

    Indianapolis, Indiana, 46219, United States

  • Community MD Anderson Cancer Center North

    Indianapolis, Indiana, 49625, United States

  • Community MD Anderson Cancer Center South

    Indianapolis, Indiana, 46227, United States

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center (Banner)

    Gilbert, Arizona, 85234, United States

  • MD Anderson Cancer Center (Banner)- Northern Colorado

    Greeley, Colorado, 80631, United States

  • Ohio Health

    Columbus, Ohio, 43215, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Scripps- MD Anderson Cancer

    San Diego, California, 92121, United States

  • UT Health San Antonio - MD Anderson Cancer Center

    San Antonio, Texas, 78229, United States

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