AzTrials
AzTrials

Breast CancerNCT02515110

Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer

A study testing External Beam Radiation Therapy in people with Breast Cancer and Node-positive Breast Cancer, run by Virginia Commonwealth University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with… Read more about this study

Who is it for?
Ages 40 years and older, women only
What is being tested?
External Beam Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
2 sitesUnited States
Study dates
4 Aug 2015to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 36Show fewer
  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • VCU Community Memorial Healthcenter

    South Hill, Virginia, 23970

Other trials in United States

About this study

Official title: Hypofractionated Regional Nodal Irradiation Phase 2 Clinical Trial for Women With Breast Cancer - HeNRIetta

Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3) plans for locoregional EBRT following mastectomy with reconstruction.

Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with reconstruction, cosmetic outcome.

Read the detailed description

The HeNRIetta Trial is a phase 2 non-randomized clinical trial to evaluate the safety and effectiveness of hypofractionated RNI for women with resected node-positive breast cancer. The study hypothesis is that a 3-4 week hypofractionated course of post-lumpectomy or postmastectomy EBRT is as safe and effective as the biologically equivalent dose given in conventional fractionation over 5-7 weeks.

Eligible patients are women ≥ 40 years old who have undergone definitive surgery for node-positive breast cancer. Surgery may have been lumpectomy, mastectomy without reconstruction, or mastectomy with reconstruction. Nodal staging may have been performed by only sentinel lymph node (SLN) or by axillary lymph node (ALN) dissection. Patients may have received neoadjuvant or adjuvant chemotherapy at the discretion of the treating medical oncologist.

Breast and RNI will be administered to 42.56 Gy in 16 fractions. (RNI will exclude the axilla in patients who have had an ALN dissection.) A treatment boost of 4 to 6 fractions of 2.66 Gy/fraction to the lumpectomy cavity will be included for all patients who have had lumpectomy; a chestwall boost (4 to 6 fractions of 2.66 Gy/fraction) will be administered to patients who had mastectomy (with or without reconstruction) and close (< 2 mm) surgical margins. Total number of EBRT fractions will be 20 to 22 with a boost; 16 without a boost.

Bilateral measurements of arm circumference will be used to assess lymphedema by comparing the ipsilateral arm to the contralateral arm. Patients will also be assessed for and will complete questionnaires related to lymphedema, decreased arm function, breast and chestwall pain, other EBRT-related toxicities, cosmetic outcome, and local, regional, and distant breast cancer recurrence.

Being tested
External Beam Radiation Therapy
Keywords
lumpectomy, mastectomy without reconstruction, mastectomy with reconstruction, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, HER2/Neu Positive, Progesterone Receptor Negative, Progesterone Receptor Positive, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
Medical subject headings
Breast Neoplasms, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam RT, RNI

    Breast or chest wall irradiation with hypofractionated regional nodal irradiation (RNI) will be delivered according to a hypofractionated treatment schedule of 16 fractions followed by boost of 4 to 6 fractions for patients who had a lumpectomy; a boost of 4 to 6 fractions may also be required for patients who had a mastectomy (with or without reconstruction) if the surgical margin is < 2 mm.

Study groups in NCT02515110
Study groupRoleWhat they receive
Treatment (EBRT)ExperimentalExternal Beam Radiation Therapy (EBRT). Within 10 weeks after the last breast cancer surgery or the last dose of adjuvant chemotherapy, patients undergo hypofractionated RNI five days a week over 3-4 weeks. The three subgroups are treatment group 1- lumpectomy, treatment group 2- mastectomy, and treatment group 3- Mastectomy/ reconstruction. They are categorized depending on type of axillary surgery and treatment group. The type of axillary surgery is Sentinel lymph node (SLN) biopsy only vs axillary dissection with or without previous SLN biopsy. The treatment groups are lumpectomy vs mastectomy vs mastectomy/reconstruction.
Receives: Radiation: External Beam Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment

    The number of participants with incidence of lymphedema defined as ≥ 10% increase in arm circumference over baseline circumference compared to the contralateral arm measured every 6 months from the time of initiation of hypofractionated irradiation of breast and regional nodes through 3 years following the completion of radiation therapy in 2 patient cohorts:

    • Patients who have only had sentinel lymph node (SLN) biopsy for axillary staging
    • Patients who have had axillary lymph node (ALN) dissection for axillary staging

    Measured: 3 years

Secondary outcomes (3)

  1. Determine 5-year rate of locoregional breast cancer recurrence

    Number of participants with recurrence of breast cancer within the breast or in the lymph nodes in the ipsilateral axilla, supraclavicular/infraclavicular fossa, or ipsilateral internal mammary chain without evidence of distant disease within 5 years following the completion of radiation therapy

    Measured: 5 years

  2. Determine 5-year rate of distant breast cancer recurrence

    The number of participants recurrence of breast cancer in any area beyond the breast and regional limits within 5 years following the completion of radiation therapy

    Measured: 5 years

  3. Evaluate arm function by the frequency of patient responses indicating moderate or large differences between ipsilateral and contralateral arm function on the Patient-Reported Outcomes Questionnaire

    PROMIS (Patient-Reported Outcomes Measurement Information System) forms use validated, standardized, and often 5-point Likert scales (e.g., Never to Always, Not at all to Very much) to assess physical, mental, and social health across various domains like pain, fatigue, and function. Form Pro-L used for treatment group 1, and Form Pro-M/R for treatment groups 2 \& 3.

    Measured: Baseline, then 1 month, then every 6 months through 3 years following EBRT, then yearly in years 4 and 5.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2015 (estimated)
  2. Study start4 Aug 2015
  3. Primary completion22 Apr 2026
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
137 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02515110
Sponsor's protocol ID
MCC-15-10994
Other IDs
HM20004979, NCI-2015-01317
Status last verified
Jun 2026
First submitted
31 Jul 2015
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing External Beam Radiation Therapy in people with Breast Cancer and Node-positive Breast Cancer, run by Virginia Commonwealth University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02515110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in