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Breast CancerPhase 2NCT02783690

A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

A Phase 2 study testing Hypofractionation in people with Breast Cancer, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized controlled trial to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Hypofractionation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesUnited States
Study dates
18 May 2016to 18 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Age ≥ 18 years
  • Histologic confirmation of breast cancer resected by mastectomy with or without immediate reconstruction and chest wall and regional nodal irradiation planned.
  • pStage T1-T4N0-N3M0 or ypStage T0-4N0-N3M0 Note: The axilla must be staged by sentinel node biopsy alone, sentinel node biopsy followed by axillary node dissection, or axillary lymph node dissection alone
  • ECOG Performance Status (PS) 0 to 2. (Appendix I).
  • Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
  • Radiotherapy must begin within 12 weeks of last surgery (breast or axilla) or last chemotherapy.
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  • Note: Breast implants and expanders allowed
  • Able to and provides IRB approved study specific written informed consent
  • Ability to complete questionnaire (s) by themselves or with assistance
  • Able to complete all mandatory tests listed in section 4.0
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Willing to provide tissue and blood samples for correlative research purposes.
  • Rochester and Arizona patients: Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136
  • Rochester patients: Willing to sign consent onto Evaluation of cardiac function in patients undergoing proton beam or photon radiotherapy, IRB number 15-007443

Who cannot join

  • Medical contraindication to receipt of radiotherapy.
  • Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent.
  • Active systemic lupus or scleroderma.
  • Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior receipt of ipsilateral breast or chest wall radiation that would result in significant overlap of radiation therapy fields. Prior contralateral radiotherapy for breast cancer is allowed.
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  • Positive margins after definitive surgery
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry
  • Inflammatory breast cancer
  • Recurrent Breast Cancer
  • Boosts to the chest wall after mastectomy. Nodal boosts are allowed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Randomized Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

This is a randomized controlled trial to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.

Conditions
Breast Cancer
Being tested
Hypofractionation
Medical subject headings
Breast Neoplasms

What participants receive

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

  • HypofractionationRadiation

    40 Gy (RBE) in 15 daily fractions

Study groups in NCT02783690
Study groupRoleWhat they receive
Conventional FractionationNo intervention50.0 Gy (RBE) in 25 daily fractions
HypofractionationExperimental40 Gy (RBE) in 15 daily fractions
Receives: Radiation: Hypofractionation

What is being measured

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

  1. Complication Rate

    Will be defined as the percentage of women randomized who develop one or more of the following events: grade 3 or higher late adverse events; unplanned surgical intervention (not including planned serial fat grafting) in patients who undergo mastectomy with reconstruction.

    Measured: 24 months

Secondary outcomes (10)

  1. Incidence of Acute Adverse Events

    Acute adverse events are defined using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 1 or 2 events occurring in at least 10% of patients are reported along with all grade 3 or higher events.

    Measured: 5 years

  2. Incidence of Late Adverse Events

    Late adverse events are defined using CTCAE version 4. Grade 1 or 2 events occurring in at least 10% of patients are reported along with all grade 3 or higher events.

    Measured: 5 years

  3. Reconstruction Failure

    A failure is defined as loss of the tissue expander or implant with the inability to replace it resulting in no final reconstruction or conversion to autologous reconstruction or revised with the addition of autologous reconstruction.

    Measured: 5 years

  4. Quality of Life - Breast Cancer Outcomes

    measured by cosmesis evaluation and the Breast Cancer Treatment Outcome Scale (BCTOS)

    Measured: 5 years

  5. Cosmesis

    measured by reviewing digital photographs and the 4 point (excellent, good, fair, poor) adaptation of the Harvard Cosmesis Scale

    Measured: baseline, 2 years, and 5 years

  6. Ipsilateral Breast Tumor Recurrence (IBTR) Incidence

    Will be defined as local recurrence from trial registration as a first event at 5 years. The IBTR cumulative incidence will be estimated using a competing risks method by treatment arm. The competing risks will be regional/distant breast cancer recurrence and death. The percentage of patients with IBTR is defined as the number of patients that have a IBTR divided by the number of patients treated in each arm.

    Measured: 5 years

  7. Distant Recurrence Incidence

    Will assess metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer at 5 years. The percentage of patients with a distant recurrence is defined as the number of patients that have a distant recurrence divided by the number of patients treated in each arm.

    Measured: 5 years

  8. Regional Recurrence Incidence

    Defined as invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast at 5 years. The percentage of patients with a regional recurrence is defined as the number of patients that have a regional recurrence divided by the number of patients treated in each arm.

    Measured: 5 years

  9. Disease-free Survival (DFS) at 3 Years

    DFS is defined as the time from study registration until the occurrence, if any, of one of the following events: invasive IBTR, regional invasive breast cancer recurrence, distant breast cancer recurrence, death due to any cause, contralateral invasive breast cancer, and second primary non-breast invasive disease. DFS at 3 years will be reported as the percent of patients without a DFS event at 3 years post radiotherapy.

    Measured: 3 years post radiotherapy, up to 38 months

  10. Overall Survival (OS) at 3 Years

    Overall survival is defined as the time from registration to death due to any cause. OS at 3 years is reported as the percentage of patients still alive and in follow up at 3 years post radiotherapy.

    Measured: 3 years post radiotherapy, up to 38 months

Timeline

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

  1. First posted26 May 2016 (estimated)
  2. Study start18 May 2016
  3. Primary completion21 Oct 2020
  4. Study completion18 Nov 2023

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783690
Sponsor's protocol ID
15-006137
Other IDs
MC1631, NCI-2017-02362
Status last verified
Aug 2024
First submitted
19 May 2016
Last updated
4 Dec 2025
Data monitoring committee
Yes

Publications

  • Mutter RW, Giri S, Fruth BF, Remmes NB, Boughey JC, Harless CA, Ruddy KJ, McGee LA, Afzal A, Gao RW, Shumway DA, Vern-Gross TZ, Villarraga HR, Kenison SL, Kang Y, Wong WW, Stish BJ, Merrell KW, Yan ES, Park SS, Corbin KS, Vargas CE. Conventional versus hypofractionated postmastectomy proton radiotherapy in the USA (MC1631): a randomised phase 2 trial. Lancet Oncol. 2023 Oct;24(10):1083-1093. doi: 10.1016/S1470-2045(23)00388-1. Epub 2023 Sep 8.

    PubMed 37696281

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypofractionation in people with Breast Cancer, run by Mayo Clinic 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 14 inclusion and 11 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: finished, as of the sponsor's last update on 4 Dec 2025. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Complication Rate (time frame: 24 months). 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 NCT02783690, which also lists 1 linked publication.

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 4 Dec 2025.

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