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Completed

NCT Number: NCT03624478

Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery

This phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before 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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. To determine the pathologic complete response (pCR) rate after hypofractionated radiotherapy to the whole breast alone, based on the postsurgical specimen.

SECONDARY OBJECTIVES:

I. To evaluate acute and late toxicity with preoperative radiation including grade >= 2 pneumonitis.

II. To estimate the 5-year locoregional control, distant recurrence, invasive disease-free survival, cause-specific survival, and overall survival.

CORRELATIVE AND EXPLORATORY OBJECTIVES:

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

III. Evaluate tumor mutation signatures before and after radiation; correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery.

IV. To describe the pathologic changes seen in breast cancer patients with preoperative radiation.

OUTLINE:

Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.

After completion of study treatment, participants are followed up at 12 weeks, 6, 12, 24, and 36 months, and 5 years after radiation therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological confirmation of breast cancer
  • Clinical stage T0-T2 N0 M0
  • 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 120 days of last biopsy (breast)
  • Able to complete all mandatory tests
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Planned breast 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
  • Women of childbearing potential who are unwilling to employ adequate contraception
  • Prior receipt of ipsilateral breast or chest wall radiation
  • Recurrent breast cancer
  • Indications for comprehensive regional nodal irradiation
  • No neo-adjuvant therapy

Treatment and study plan

Hypofractionated Radiation Therapy

Radiation

Undergo hypofractionated radiation therapy

Other names: Hypofractionated Radiotherapy, hypofractionation

Primary outcomes

  1. Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen

    Time frame: up to 2 years

    The proportion of successes (number of patients achieving pCR at time of definitive surgery) will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Secondary outcomes

  1. Number of Participants With Acute Adverse Events (AE)

    Time frame: Up to 180 days post radiation therapy

    The maximum grade for each type of acute AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

  2. Incidence of Late Adverse Events

    Time frame: Up to 5 years post radiation therapy

    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. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

  3. Locoregional Control

    Time frame: Up to 5 years

    The cumulative incidence of locoregional recurrence will be estimated using a competing risks method (Gooley et al.). The competing risks will be distant breast cancer recurrence and death.

  4. Invasive Disease-free Survival

    Time frame: From 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. Estimates will be given for specific time points along with 95% confidence intervals (CIs).

  5. Distant Recurrence

    Time frame: Up to 5 years

  6. Disease- Free Survival

    Time frame: From 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. Estimates will be given for specific time points along with 95% CIs.

  7. 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. Estimates will be given for specific time points along with 95% CIs.

  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. Estimates will be given for specific time points along with 95% CIs.

Other outcomes

  1. Patient Self-reporting of Toxicities

    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 +/- SD and median (minimum value, maximum value). Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Analysis will include percent change from baseline using t-tests and generalized linear models to test for changes at each time point and non-zero slope respectfully.

  2. Patient Self-reported Cosmetic Outcomes

    Time frame: Baseline up to 5 years

    Assessed using a modified Harvard Cosmesis Scale and the BCTOS. 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.

  3. Panel Assessed Cosmetic Outcome

    Time frame: Baseline up to 2 years

    Cosmesis will be assessed by a panel of breast cancer medical providers using digital photographs.

  4. Clinical Features, Treatment Technique, Dose-volume Parameters, Histologic and Genetic Variants

    Time frame: Up to 5 years

    Associated with adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention.

  5. Tumor Mutation Signatures

    Time frame: Up to 5 years

    Will be analyzed before and after radiotherapy as compared to pathologic information at the time of surgery. Continuous variable will be compared using unpaired t tests and nominal variables will be compared using contingency tables and Chi square analyses.

  6. Pathologic Changes Seen in Breast Cancer Patients With Preoperative Radiation

    Time frame: Up to 5 years

    Will be described.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot/Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery

Important dates

Study start
2018
Primary completion
2021
Study completion
2025
First posted
Aug 10, 2018
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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