NCT04871516Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 103 (actual)
- First submitted
- 13 Oct 2020
- Start date
- 18 May 2021
- Primary completion date
- 5 Dec 2027
- Lead sponsor
- Rutgers, The State University of New Jersey
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04871516
What you commit to
- Study type: Interventional
- Participants enrolled: 103
- From 18 May 2021 to the primary completion date, 5 Dec 2027
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Need for neoadjuvant chemotherapy
- Prior ipsilateral breast or thoracic RT
- Contraindication for surgery
Other illness
- Inflammatory breast cancer (cT4)
- 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
Other
- Multicentric tumor
- Contraindication for baseline magnetic resonance imaging (MRI)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clara Maass Medical Center Coordinator of this site? Confirm its status | Belleville | United States | Unknown status |
| RWJBarnabas Health-Trinitas Hospital and Comprehensive Care Coordinator of this site? Confirm its status | Elizabeth | United States | Unknown status |
| The Cancer Institute of New Jersey Hamilton Coordinator of this site? Confirm its status | Hamilton | United States | Unknown status |
| RWJBarnabas Health- Jersey City Medical Center Coordinator of this site? Confirm its status | Jersey City | United States | Unknown status |
| RWJBarnabas Health - Monmouth Medical Center Southern Campus Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) Coordinator of this site? Confirm its status | Livingston | United States | Unknown status |
| Rutgers New Jersey Medical School Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| RWJBarnabas Health - Newark Beth Israel Medical Center Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Robert Wood Johnson University Hospital Somerset Coordinator of this site? Confirm its status | Somerville | United States | Unknown status |
| RWJBarnabas Health - Community Medical Center Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.