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

Description

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.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Invasive Breast Carcinoma, Non-Metastatic Breast Carcinoma, Prognostic Stage 0 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 II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Anatomic Stage 0 Breast Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Belleville

Clara Maass Medical Center, Belleville, New Jersey, United States, 07109

Elizabeth

RWJBarnabas Health-Trinitas Hospital and Comprehensive Care, Elizabeth, New Jersey, United States, 07202

Hamilton

The Cancer Institute of New Jersey Hamilton, Hamilton, New Jersey, United States, 08690

Jersey City

RWJBarnabas Health Jersey City Medical Center, Jersey City, New Jersey, United States, 07302

Lakewood

RWJBarnabas Health - Monmouth Medical Center Southern Campus, Lakewood, New Jersey, United States, 08701

Livingston

Cooperman Barnabas Medical Center (Saint Barnabas Medical Center), Livingston, New Jersey, United States, 07039

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08903

Newark

Rutgers New Jersey Medical School, Newark, New Jersey, United States, 07101

Newark

RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey, United States, 07112

Somerville

Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States, 08876

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rutgers, The State University of New Jersey,

Bruce G Haffty, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

2024-01-31