ACTIVE_NOT_RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2021-05-18
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04871516

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Breast cancer patients with biopsy proven invasive cancer
  2. * Clinically and radiographically node negative
  3. * No indication of metastatic disease
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  5. * Synchronous bilateral invasive cancer allowed
  6. * Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
  7. * Willingness to participate in the clinical trial and adhere to the study protocol
  8. * Individuals of all races, genders and ethnic groups are eligible for this trial
  1. * Need for neoadjuvant chemotherapy
  2. * Inflammatory breast cancer (cT4)
  3. * Multicentric tumor
  4. * Prior ipsilateral breast or thoracic RT
  5. * Contraindication for baseline magnetic resonance imaging (MRI)
  6. * Contraindication for surgery
  7. * Distant metastatic disease
  8. * Other synchronous cancer (besides bilateral breast)
  9. * Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
  10. * 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

Contacts and Locations

Principal Investigator

Bruce G Haffty
PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

Clara Maass Medical Center
Belleville, New Jersey, 07109
United States
RWJBarnabas Health-Trinitas Hospital and Comprehensive Care
Elizabeth, New Jersey, 07202
United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690
United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
United States
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Livingston, New Jersey, 07039
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-18
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2021-05-18
Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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