This clinical trial compares the use of single fraction accelerated partial breast irradiation with five fraction accelerated partial breast irradiation in treating patients with low-risk stage 0 and I breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Single fraction accelerated partial breast irradiation is radiation therapy given in a single day. Five fraction accelerated partial breast irradiation is radiation therapy given over the course of five days. Giving single fraction accelerated partial breast irradiation after surgery may work better in reducing the risk of breast cancer coming back compared to five fraction accelerated partial breast irradiation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04849871.
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility of conducting a randomized trial of adjuvant partial breast radiation regiments in this population.
II. To estimate the ipsilateral breast tumor recurrence (IBTR) rate at 5 years after single fraction (S)_ accelerated partial breast irradiation (APBI) versus (vs.) five fraction (F)_APBI as the sole radiation therapy technique following partial mastectomy.
SECONDARY OBJECTIVES:
I. To quantify the tolerance of S_APBI vs. F_APBI by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per Common Terminology Criteria for Adverse Events [CTCAE], version [v] 5.0) or any other grade 4 or 5 toxicity attributed to the therapy.
II. To quantify the proportion of patients who are free of breast cancer recurrence in the regional lymph nodes (defined as the ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups) at five years after S_APBI vs. F_APBI.
III. To quantify the proportion of patients who are free of breast cancer distance metastases at five years after S_APBI vs. F_APBI.
IV. To describe quality of life over time as measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QLQ)-30 AND QLQBR23 questionnaires.
V. To measure cosmesis over time quantitatively by the BRA and pBRA and qualitatively by the Aronson modified Harris scale.
VI. To describe the presence of any other complications using CTCAE v 5.0 criteria.
VII. To quantify the proportion of patients undergoing mastectomy on the treated side at 5 years after S_APBI vs. F_APBI.
VIII. To describe the frequency of any CTCAE v5.0 grade 3-4 toxicities.
TERITARY OBJECTIVE:
I. To evaluate whether serum inflammatory/other biomarker levels pre- and post-treatment correlate with development of toxicities, notably radiation-induced fibrosis.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Within 8 weeks after standard of care surgery, patients undergo external beam APBI in 1 fraction. Patients also undergo collection of blood at 1 month to start of treatment.
ARM II: Within 8 weeks after standard of care surgery, patients undergo external beam APBI in 5 fractions over 5 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at 1 month to start of treatment.
After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months, 4 and 5 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorImran Zoberi