This clinical trial studies the side effects of accelerated partial breast irradiation (APBI) and how well it works in treating patients with breast cancer has not spread beyond the breast and the axillary (armpit area) lymph nodes (early stage). Radiation therapy is a treatment for cancer and some other diseases. It uses high-energy rays (similar to X-rays) to damage and kill tumor cells, while trying to protect the healthy cells around them. The standard of care for early stage breast cancer is delivering radiation treatment to the whole breast after surgery followed by a boost (additional radiation) to the tumor bed, which is the area where the tumor used to be. APBI is a type of radiation therapy given only to the part of the breast that has cancer in it. Accelerated partial-breast irradiation gives a higher dose over a shorter time than is given in standard whole-breast radiation therapy. By giving APBI prior to surgery, when doctors can still visualize the tumor, doctors may be able to target the tumor better and minimize the radiation that the normal breast tissue would receive. By doing so, doctors may achieve better cosmetic outcomes and possibly better tumor control.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07178665.
Locations matching your search criteria
United States
New Jersey
Belleville
Clara Maass Medical CenterStatus: Active
Contact: Dolly Razdan
Phone: 973-450-2000
Elizabeth
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street CampusStatus: Active
Contact: Clarissa Febles Henson
Phone: 800-994-8000
Hamilton
The Cancer Institute of New Jersey HamiltonStatus: Active
Contact: Rachana Singh
Phone: 609-631-6960
Jersey City
Jersey City Medical CenterStatus: Active
Contact: Alan M Shaiman
Phone: 201-915-2000
Livingston
Saint Barnabas Medical CenterStatus: Active
Contact: Alison Grann
Phone: 973-322-5200
Long Branch
Monmouth Medical CenterStatus: Active
Contact: Mitchell F. Weiss
Phone: 732-222-1711
New Brunswick
Rutgers Cancer Institute of New JerseyStatus: Active
Contact: Nisha Ohri
Phone: 732-235-5203
Newark
Newark Beth Israel Medical CenterStatus: Active
Contact: Charles S. Cathcart
Phone: 973-926-7230
Somerville
Robert Wood Johnson University Hospital SomersetStatus: Active
Contact: Laura Rothfeld Bond
Phone: 908-927-8702
Toms River
Community Medical CenterStatus: Active
Contact: Rajesh V. Iyer
Phone: 732-557-8148
PRIMARY OBJECTIVES:
I. To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic and clinically node negative breast cancer or ductal carcinoma in situ (DCIS) who are eligible for breast conserving surgery (BCS) and treated with pre-operative partial breast irradiation (PBI) at 1 month is no worse than the rates in the current standard of care (6-20%).
II. To measure the pre-operative APBI clinical target volume (CTV) and compare it to the post-operative (op) APBI CTV volume that would have been contoured as CTV if the partial breast was to be delivered post-operatively.
III. To measure the incidence of fair/poor patient-reported cosmetic outcomes using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale.
IV. To study cancer biology before and after radiation treatment.
SECONDARY OBJECTIVE:
I. To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI) (around 35% reported poor/fair cosmesis at 3 years, Shaitelman et al.).
TERTIARY OBJECTIVES:
I. To measure acute and late radiation-related toxicities, such as radiation dermatitis, telangiectasia, and fibrosis, in this cohort of patients and to measure biologic markers that radiation may influence.
OUTLINE:
Patients undergo APBI every other day over 10-15 minutes for 5 treatment sessions in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care (SOC) breast surgery 1-3 weeks after completion of APBI. Patients with positive lymph nodes at the time of surgery may receive additional radiation therapy (RT) over 15 treatment sessions at the discretion of the treating physician. Patients also undergo magnetic resonance imaging (MRI) and mammogram at baseline, as well as optional blood sample collection and photographs of breasts throughout the study.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, then every 6-12 months for 3 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorNisha Ohri
