Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
Running, not enrolling · Not applicable
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT04871516
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 103
- Starts
- 2021-05-18
- Expected to finish
- 2028-01-31
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clara Maass Medical Center — Belleville, New Jersey, United States
- RWJBarnabas Health-Trinitas Hospital and Comprehensive Care — Elizabeth, New Jersey, United States
- The Cancer Institute of New Jersey Hamilton — Hamilton, New Jersey, United States
- RWJBarnabas Health Jersey City Medical Center — Jersey City, New Jersey, United States
- RWJBarnabas Health - Monmouth Medical Center Southern Campus — Lakewood, New Jersey, United States
- Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) — Livingston, New Jersey, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Rutgers New Jersey Medical School — Newark, New Jersey, United States
- RWJBarnabas Health - Newark Beth Israel Medical Center — Newark, New Jersey, United States
- Robert Wood Johnson University Hospital Somerset — Somerville, New Jersey, United States
- RWJBarnabas Health - Community Medical Center — Toms River, New Jersey, United States
Full record on ClinicalTrials.gov
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