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Stage I Breast Cancer AJCC v7Phase 3NCT03324802

Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery

A Phase 3 study testing Hypofractionated Radiation Therapy, Quality-of-Life Assessment and Radiation Therapy in people with Stage I Breast Cancer AJCC v7 and Stage IA Breast Cancer AJCC v7, run by Mayo Clinic at 3 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 randomized phase III trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hypofractionated Radiation Therapy, Quality-of-Life Assessment and Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
3 sitesUnited States
Study dates
7 Feb 2018to 28 Aug 2023
Phase
Phase 3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmation of breast cancer
  • Pathologic stage T0-T3N0-N1M0
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
  • Able to and provides Institutional Review Board (IRB) approved study specific written informed consent
  • Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable)
  • Able to complete all mandatory tests
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  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale
  • Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy
  • Breast conserving surgery and indications for whole breast radiotherapy

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
  • Prior receipt of ipsilateral breast or chest wall radiation
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  • Positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer
  • 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
  • Recurrent breast cancer
  • Indications for comprehensive regional nodal irradiation

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the 24-month complication rate of 5 fraction whole radiotherapy +/- concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost.

SECONDARY OBJECTIVES:

  1. To evaluate acute and late toxicity. II. To estimate the 5-year locoregional control, invasive disease-free survival and overall survival.

TERTIARY OBJECTIVES:

  1. To evaluate fatigue, and other patient-reported outcomes. II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with fair and poor cosmetic outcomes or unplanned surgical intervention.

III. To evaluate the costs and comparative effectiveness of treatment. IV. Compare the use of photon therapy with spot scanning proton therapy in two different hypo-fractionated whole breast schemas.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo radiation therapy in 15 daily fractions for 10 days.

ARM II: Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days.

After completion of study treatment, patients are followed up to 5 years.

Being tested
Hypofractionated Radiation Therapy, Quality-of-Life Assessment, Radiation Therapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Hypofractionated Radiation TherapyRadiation

    Also called Hypofractionated Radiotherapy, hypofractionation

    Undergo hypofractionated radiation therapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation

    hypofractionated radiation therapy

Study groups in NCT03324802
Study groupRoleWhat they receive
Arm 2 (hypofractionated radiation therapy, 5 fractions)ExperimentalWithin 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days.
Receives: Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment
Arm I (radiation therapy, 15 fractions)ExperimentalWithin 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days.
Receives: Other: Quality-of-Life Assessment; Radiation: Radiation Therapy

What is being measured

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

  1. Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor

    The complication rate will be reported by arm.

    Measured: 24 months

Secondary outcomes (8)

  1. Cause-specific Survival

    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for one year with 95% CIs. Comparison between arms will employ a log-rank test.

    Measured: 1 year

  2. Overall Survival

    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for one year along with 95% CIs. Comparison between arms will employ a log-rank test.

    Measured: 1 year

  3. Number of Patients Experiencing Distant Recurrence

    Distant recurrence defined as metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer

    Measured: 5 years

  4. Number of Patients Experiencing Acute (Grade 3+) Adverse Events (AEs)

    The maximum grade for each type of acute (grade 3+) AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. The relationship of the adverse event(s) to the study treatment will be taken into consideration. Number of patients experiencing one or more grade 3+ events will be compared between arms using chi-squared tests. Adverse events were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: 3 months

  5. Number of Patients Experiencing Grade 3+ Late Adverse Events

    The maximum grade for each type of late AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. The relationship of the adverse event(s) to the study treatment will be taken into consideration. Number of patients experiencing one or more grade 3+ late AEs will be compared between arms using chi-squared tests.

    Measured: 24 months

  6. Invasive Disease-free

    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Median invasive disease-free time will be given along with standard error. Comparison between arms will employ a log-rank test.

    Measured: 5 years

  7. Percent of Patients With Locoregional Recurrence

    The cumulative incidence of locoregional recurrence will be estimated using a competing risks method by treatment arm. The competing risks will be distant breast cancer recurrence and death. Comparison between arms will employ Fine-Gray regression. Locoregional recurrence is clinically diagnosed invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast at 5 years.

    Measured: 5 years

  8. Disease-Free Survival

    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Median disease free survival time and standard error will be estimated. Comparison between arms will employ a log-rank test.

    Measured: 5 years

Timeline

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

  1. First posted30 Oct 2017
  2. Study start7 Feb 2018
  3. Primary completion31 Jan 2022
  4. Study completion28 Aug 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03324802
Sponsor's protocol ID
MC1635
Other IDs
NCI-2017-01944, MC1635
Status last verified
Apr 2024
First submitted
20 Oct 2017
Last updated
2 May 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Laughlin BS, Corbin KS, Toesca DAS, Thorpe CS, Golafshar MA, Pockaj B, Cronin P, McGee LA, Halyard MY, Mutter RW, Keole SR, Park SS, Shumway DA, Vern-Gross TZ, Vallow L, Wong WW, DeWees TA, Vargas CE. Physician- and Patient-Reported Outcomes of the MC1635 Phase 3 Trial of Ultrahypofractionated Versus Moderately Hypofractionated Adjuvant Radiation Therapy After Breast-Conserving Surgery. Int J Radiat Oncol Biol Phys. 2024 Mar 15;118(4):1049-1059. doi: 10.1016/j.ijrobp.2023.10.018. Epub 2023 Oct 31.

    PubMed 37914139

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hypofractionated Radiation Therapy, Quality-of-Life Assessment and Radiation Therapy in people with Stage I Breast Cancer AJCC v7 and Stage IA Breast Cancer AJCC v7, run by Mayo Clinic at 3 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 10 inclusion and 10 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 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Jun 2023). 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, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor (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 NCT03324802, 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 2 May 2024.

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