Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

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

NCT04871516 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • RADIATION Radiation Boost
  • RADIATION Whole Breast Irradiation
  • PROCEDURE Therapeutic Surgical Procedure

Study Locations (11)

New Jersey

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

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2021-05-18
Est. Completion 2028-01-31
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04871516

The ClinicalTrials.gov registry entry for NCT04871516 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Quality-of-Life Assessment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04871516 reports 11 study locations spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04871516 about?

NCT04871516 is a clinical study titled "Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer". 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...

What is the current status of trial NCT04871516?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 103 participants. The study started on 2021-05-18. Estimated completion is 2028-01-31.

What conditions does trial NCT04871516 study?

This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Invasive Breast Carcinoma, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04871516?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Radiation Boost (RADIATION), Whole Breast Irradiation (RADIATION), Therapeutic Surgical Procedure (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04871516?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04871516 being conducted?

This trial has 11 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial