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.
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
- Conditions the study is for
- Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
- 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
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
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:
- To determine the 24-month complication rate of 5 fraction whole radiotherapy +/- concurrent boost as compared to 15 fraction radiotherapy +/- sequential boost.
SECONDARY OBJECTIVES:
- To evaluate acute and late toxicity. II. To estimate the 5-year locoregional control, invasive disease-free survival and overall survival.
TERTIARY OBJECTIVES:
- 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.
- Conditions
- Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
- 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 group | Role | What they receive |
|---|---|---|
| Arm 2 (hypofractionated radiation therapy, 5 fractions) | Experimental | Within 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) | Experimental | Within 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.
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)
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
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
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
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
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
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
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
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.
- First posted30 Oct 2017
- Study start7 Feb 2018
- Primary completion31 Jan 2022
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage I Breast Cancer AJCC v7Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Vargas, Principal investigator, Mayo Clinic
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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