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

NCT04871516 · tracked via the Priya Life Science Israel tracker

Sponsor

Rutgers, The State University of New Jersey

Phase

Not applicable

Started

2021-05-18

Last updated

2026-01-22

Condition(s) studied

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Invasive Breast CarcinomaNon-Metastatic Breast CarcinomaPrognostic Stage 0 Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8

Investigational drug(s) / intervention(s)

Quality-of-Life AssessmentQuestionnaire AdministrationRadiation BoostTherapeutic Surgical ProcedureWhole Breast IrradiationBreast MRI

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Radiation Boost: Undergo radiation therapy boost

Therapeutic Surgical Procedure: Undergo standard surgery

Whole Breast Irradiation: Undergo standard WBI

Breast MRI: A baseline breast MRI

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Breast cancer patients with biopsy proven invasive cancer * Clinically and radiographically node negative * No indication of metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Synchronous bilateral invasive cancer allowed * Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery * Willingness to participate in the clinical trial and adhere to the study protocol * Individuals of all races, genders and ethnic groups are eligible for this trial Exclusion Criteria: * Need for neoadjuvant chemotherapy * Inflammatory breast cancer (cT4) * Multicentric tumor * Prior ipsilateral breast or thoracic RT * Contraindication for baseline magnetic resonance imaging (MRI) * Contraindication for surgery * Distant metastatic disease * Other synchronous cancer (besides bilateral breast) * Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease) * Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results

Primary outcome measure(s)

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. — For at least 36 months after WBI
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.

Trial sites (11)

Facility	City	Region
Clara Maass Medical Center	Belleville	New Jersey
RWJBarnabas Health-Trinitas Hospital and Comprehensive Care	Elizabeth	New Jersey
The Cancer Institute of New Jersey Hamilton	Hamilton	New Jersey
RWJBarnabas Health Jersey City Medical Center	Jersey City	New Jersey
RWJBarnabas Health - Monmouth Medical Center Southern Campus	Lakewood	New Jersey
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)	Livingston	New Jersey
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
Rutgers New Jersey Medical School	Newark	New Jersey
RWJBarnabas Health - Newark Beth Israel Medical Center	Newark	New Jersey
Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey
RWJBarnabas Health - Community Medical Center	Toms River	New Jersey

More Rutgers, The State University of New Jersey trials in Israel

Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer Recruiting

sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE) Recruiting

ATATcH Alternating Treatment Plans for Advanced Cancer Recruiting

CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage Active, not recruiting

COMMETS- Combination MCI Metabolic Syndrome Recruiting

Other trials for the same condition

Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer Recruiting

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Active, not recruiting

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Active, not recruiting

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial Active, not recruiting

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04871516 on ClinicalTrials.gov ↗ ← All trials in Israel