Clinical trial NCT03624478: Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery
Official title: A Pilot/Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen
timeFrame: up to 2 years
Secondary outcomes:
measure: Number of Participants With Acute Adverse Events (AE)
timeFrame: Up to 180 days post radiation therapy
measure: Incidence of Late Adverse Events
timeFrame: Up to 5 years post radiation therapy
measure: Locoregional Control
timeFrame: Up to 5 years
measure: Invasive Disease-free Survival
timeFrame: From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years
measure: Distant Recurrence
timeFrame: Up to 5 years
measure: Disease- Free Survival
timeFrame: From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years
measure: Cause-specific Survival
timeFrame: From registration to death due to breast cancer assessed up to 5 years
measure: Overall Survival
timeFrame: From registration to death due to any cause assessed up to 5 years
Other outcomes:
measure: Patient Self-reporting of Toxicities
timeFrame: Up to 5 years
measure: Patient Self-reported Cosmetic Outcomes
timeFrame: Baseline up to 5 years
measure: Panel Assessed Cosmetic Outcome
timeFrame: Baseline up to 2 years
measure: Clinical Features, Treatment Technique, Dose-volume Parameters, Histologic and Genetic Variants
timeFrame: Up to 5 years
measure: Tumor Mutation Signatures
timeFrame: Up to 5 years
measure: Pathologic Changes Seen in Breast Cancer Patients With Preoperative Radiation
timeFrame: Up to 5 years
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Carlos E. Vargas, M.D.
role: PRINCIPAL_INVESTIGATOR
References: