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Shorter radiation may reduce arm swelling in breast cancer patients

NCT ID NCT02515110

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a shorter course of radiation (hypofractionated) to the breast and nearby lymph nodes in 137 women with node-positive breast cancer. The goal is to see if this approach reduces arm swelling (lymphedema) and other side effects while still preventing cancer from coming back. Participants are grouped by their surgery type and followed for 3 years.

What this could mean

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

Active substance
External beam radiation therapy (hypofractionated)
What this could lead to
If successful, this could offer a shorter, more convenient radiation schedule with fewer long-term side effects like arm swelling.
What could go wrong
This is a single-arm phase 2 study with no comparison group, so results are preliminary. The shorter schedule may not control cancer as well as standard 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

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 137 people

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

Started

Aug 2015

Expected to finish

Apr 2028

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

40 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: * Karnofsky performance status of 70-100% * Histologic documentation of invasive adenocarcinoma of the breast * One of the breast disease stages listed below: * Note: In the definitions below, definitive surgery is defined as the final surgery performed to obtain clear surgical margins * Neoadjuvant chemotherapy was not administered \*\* If neoadjuvant chemotherapy was NOT administered, pathologic staging must be T1-3, N1-2a following definitive surgery * Neoadjuvant chemotherapy was administered * If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N0, pathologic staging must be T1-3, N1-2a following definitive surgery * If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N1, pathologic staging must be T0-3, N0-2a following definitive surgery * If prior to initiation of neoadjuvant chemotherapy there was cytologic or pathologic confirmation of axillary nodal involvement (per any of the criteria listed below), pathologic staging must be T0-3, N0-2a following definitive surgery * Positive fine-needle aspiration (FNA) (ie, demonstrating malignant cells) * Positive core needle biopsy (ie, demonstrating invasive adenocarcinoma) * Positive sentinel lymph node biopsy (ie, demonstrating invasive adenocarcinoma) * Complete resection of known breast disease by one of the following surgeries: * Lumpectomy with sentinel lymph node or axillary lymph node dissection * Mastectomy alone with sentinel lymph node or axillary lymph node dissection * Mastectomy plus reconstruction with sentinel lymph node or axillary lymph node dissection * Margins of the resected specimen or re-excision specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist \* Notes: Additional operative procedures may be performed to obtain clear margins; focally positive margins are acceptable based on technical feasibility of additional surgery and/or the potential for benefit with further surgery based on the extent and location of the positive margin (eg, focally positive deep margin at the pectoralis fascia); also, patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection * Estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) testing performed on the primary breast tumor; when applicable, testing must have been performed prior to neoadjuvant chemotherapy * Interval between the last surgery for breast cancer (including re-excision of margins) or the completion of adjuvant chemotherapy and study enrollment must be =\< 56 days (ie, a maximum of 8 weeks) \* Note: Radiotherapy must begin within 10 weeks following the last surgery for breast cancer or the last dose of adjuvant chemotherapy * Recovery from surgery with the incision completely healed and no signs of infection * If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of external beam radiation therapy (EBRT) should have resolved * Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative pregnancy test within 14 days prior to study registration \* Note: Postmenopausal is defined as one or more of the following: * Age \>= 60 years * Age \< 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range * Bilateral oophorectomy * Women of child-bearing potential (WCBP) must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment * Ability to understand and willingness to sign the consent form written in English pregnancy test within 14 days prior to study registration \* Note: Postmenopausal is defined as one or more of the following: * Age \>= 60 years * Age \< 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range * Bilateral oophorectomy * Women of child-bearing potential (WCBP) must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment * Ability to understand and willingness to sign the consent form written in English Exclusion Criteria: * Known definitive clinical or radiologic evidence of metastatic disease * T4 tumors including inflammatory breast cancer * Clinical nodal staging of N2 or N3 disease * Pathologic nodal staging of N2b, N2c, or N3 disease * Microscopic positive margins after definitive surgery \* Note: Patients with microscopically focally positive margins following lumpectomy or mastectomy are not excluded if re-excision is not technically feasible and/or there is no benefit to further surgery based on the extent and location of the positive margin * Any history, not including the index cancer, of ipsilateral or contralateral invasive breast cancer or ipsilateral or contralateral DCIS treated with radiation therapy (RT) \* Note: Patients with synchronous or previous ipsilateral LCIS are eligible * Any radiation therapy (RT) for the currently diagnosed breast cancer prior to study enrollment * History of ipsilateral or contralateral breast or thoracic RT for any condition * History of ipsilateral or contralateral axillary surgery for any condition * History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past * Synchronous contralateral breast cancer requiring RT * Overall geometry (eg, breast size if intact breast) precludes the ability to achieve dosimetric requirements \* Note: Set-up devices for breast positioning are permitted * Unresolved post-surgical complications (eg, significant infection) with healing difficulties * Active collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma * Pregnancy or breastfeeding * Diagnosis or treatment for a non-breast malignancy within 5 years of study registration, with the following exceptions: complete resection of basal cell carcinoma or squamous cell carcinoma of the skin and any in situ malignancy after curative therapy * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

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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

  • VCU Community Memorial Healthcenter

    South Hill, Virginia, 23970, United States

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298, United States

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