NCT04871516|Active Not RecruitingDMCFDA Device

Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer

A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients

Rutgers, The State University of New Jersey ClinicalTrials.gov

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4 other identifiers

Pro2020001306NCI-2020-05711042005P30CA072720

Study Type

interventional

Target

103

Locations

1 country

Sites

Timeline

RegisteredMay 2021

StartedMay 2021

CompletionJan 2028

Brief Summary

This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

103

participants targeted

Target at P50-P75 for not_applicable

Timeline

21mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach

1 country

11 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.7 years study duration

Study Progress74%

May 2021Jan 2028

First Submitted

Initial submission to the registry

October 13, 2020

Completed

7 months until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed

14 days until next milestone

Study Start

First participant enrolled

May 18, 2021

Completed

6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2027

Expected

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

6.6 years

First QC Date

October 13, 2020

Last Update Submit

January 21, 2026

Outcome Measures

Primary Outcomes (1)

Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.
For at least 36 months after WBI

Secondary Outcomes (3)

Physician reported cosmesis
At 1 month after whole breast irradiation (WBI)
Physician reported cosmesis
At 12 months after WBI
Physician reported cosmesis
At 36 months after WBI

Other Outcomes (6)

Acute and late radiation toxicity
Up to 24 months after WBI
Patient reported cosmesis
At 1 month after WBI
Patient reported cosmesis
At 12 months after WBI
+3 more other outcomes

Study Arms (1)

Treatment (radiation therapy boost, WBI)

EXPERIMENTAL

Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.

Other: Quality-of-Life AssessmentOther: Questionnaire AdministrationRadiation: Radiation BoostProcedure: Therapeutic Surgical ProcedureRadiation: Whole Breast IrradiationOther: Breast MRI