Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer

Conditions

• Node-positive Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Hypofractionated radiation — RADIATION
  External beam photon therapy with IMRT or VMAT to the breast/chestwall and regional lymph nodes, including supraclavicular, infraclavicular, axillary, and internal mammary nodes,
• Ultra-hypofractionated breast/chest wall and regional nodal radiation — RADIATION
  External beam photon therapy with IMRT or VMAT to the breast/chestwall and regional lymph nodes, including supraclavicular, infraclavicular, axillary, and internal mammary nodes

Study Details

In breast cancer patients with nodal involvement, numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and distant metastases, in addition to improving survival. The dose and fractionation for adjuvant breast radiation therapy has evolved over time, as novel schedules have been compared to the current standard of care. Hypofractionated radiation therapy (266 cGy per fraction x 15-16 fractions over 3 weeks) has been shown to result in equivalent oncologic outcomes, as well as equivalent acute and late toxicity, when compared to standard fractionation (200 cGy per fraction x 25 fractions over 5 weeks). Subsequently, hypofractionated breast radiation has become the current standard of care. More recently, ultra-hypofractionated breast radiation (520 cGy per fraction x 5 fractions over 1 week) was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy. However, the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported. This is important, as there is greater radiation exposure to several normal tissues, such as the arm/shoulder, brachial plexus, normal lymphatics, heart, and lung, when treating the regional nodes. In this randomized study, the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) against hypofractionated radiation (RT). The investigators will evaluate acute and late toxicity, oncologic outcomes (including local recurrence, regional recurrence, distant metastasis, and overall survival), cosmesis, and patient-reported quality of life. The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity.

Key Dates

Start date

Aug 27, 2024

Status verified

Jan 2026

Primary completion

Apr 30, 2034

Completion

Apr 30, 2034

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Hypofractionated radiation (RT)
  Breast/chest wall and nodal radiation (4256 cGy in 16 fractions over 3-4 weeks).
• Experimental: Ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT)
  Breast/chest wall and nodal radiation (2600 cGy in 5 fractions over 1-2 weeks).

Primary Outcome Measure

Proportion of patients who are free of serious treatment related late toxicity. [ Time Frame: Day 91 through 5 year follow-up (estimated to be 5 years and 1 month) ]

Central Contacts

• Maria Thomas, M.D., Ph.D.
  314-362-8615
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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