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

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ClinicalTrials.gov Identifier: NCT03324802
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This randomized phase II 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.

Condition or disease Intervention/treatment Phase
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 Stage IIIA Breast Cancer AJCC v7 Radiation: Hypofractionated Radiation Therapy Other: Quality-of-Life Assessment Radiation: Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

TERTIARY OBJECTIVES:

I. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone After Breast Conserving Surgery
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm 2 (hypofractionated radiation therapy, 5 fractions)
Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Experimental: Arm I (radiation therapy, 15 fractions)
Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Radiation Therapy
hypofractionated radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation




Primary Outcome Measures :
  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 [ Time Frame: 24 months ]
    The complication rate will be estimated using a binomial estimator in both experimental arm and control arm, and a one-sided 90% confidence interval of the difference will be computed with normal approximation.


Secondary Outcome Measures :
  1. Cause-specific survival [ Time Frame: From registration to death due to breast cancer, assessed up to 5 years ]
    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% CIs. Comparison between arms will employ a log-rank test.

  2. Disease- free survival [ Time Frame: From study registration until the time of disease recurrence or death due to any cause, assessed up to 5 years ]
    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% CIs. Comparison between arms will employ a log-rank test.

  3. Distant recurrence defined as metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer [ Time Frame: Up to 5 years ]
  4. Incidence of acute adverse events (AEs) [ Time Frame: Up to 180 days post-radiation therapy (RT) ]
    The maximum grade for each type of acute 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. Rates will be compared between arms using chi-squared tests.

  5. Incidence of late adverse events [ Time Frame: Up to 5 years post-RT ]
    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. Rates will be compared between arms using chi-squared tests.

  6. Invasive disease-free [ Time Frame: From study registration until the time of invasive disease recurrence (not including ductal carcinoma in situ [DCIS]) or death due to any cause, assessed up to 5 years ]
    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% confidence intervals (CIs). Comparison between arms will employ a log-rank test.

  7. Locoregional control [ Time Frame: Up to 5 years ]
    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.

  8. Overall survival [ Time Frame: From registration to death due to any cause, assessed up to 5 years ]
    Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for specific time points along with 95% CIs. Comparison between arms will employ a log-rank test.


Other Outcome Measures:
  1. Patient reported outcomes/quality of life [ Time Frame: Up to 5 years ]
    The subscales of the Breast Cancer Treatment Outcomes Scale (BCTOS), elements from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and other patient reported measures such as fatigue, breast pain, breast shape, and arm related morbidity outlined in the appendix will be summarized as the mean +/- standard deviation and median (minimum value, maximum value). Mixed models will be used to estimate changes at fixed time points.

  2. Patient reported outcomes/quality of life [ Time Frame: Up to 5 years ]
    The subscales of the Breast Cancer Treatment Outcomes Scale (BCTOS), elements from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and other patient reported measures such as fatigue, breast pain, breast shape, and arm related morbidity outlined in the appendix will be summarized as the mean +/- standard deviation and median (minimum value, maximum value). Mixed models will be used to compare outcomes between arms.

  3. Patient self-reported cosmesis [ Time Frame: Baseline up to 5 years ]
    Will evaluate fatigue, breast pain, arm function. The values of the cosmesis instruments (patient self-reported and panel-assessed) will be summarized with the frequencies and confidence intervals of fair or poor cosmesis events at baseline, 2 years, and 5 years by treatment arm. Comparisons between arms will employ chi-squared tests.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324802


Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Carlos E. Vargas         
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Laura Vallow, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Kimberly S. Corbin         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carlos Vargas Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03324802     History of Changes
Obsolete Identifiers: NCT03339934
Other Study ID Numbers: MC1635
NCI-2017-01944 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1635 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases