NCT06954831

Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer

Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the impact of UF-WBI + CB as assessed by patient-reported Global Cosmesis Score (GCS) at 1 year. SECONDARY OBJECTIVES: I. To characterize the patient-reported cosmetic appearance of the breast over time, as assessed by GCS. II. To determine short- and long-term physician-reported cosmetic appearance of the breast, as assessed by GCS. III. To evaluate the acute and late patient-reported radiation-associated toxicities. IV. To evaluate the acute and late physician-reported radiation-associated toxicities. V. To estimate: Va. 5-year in-breast recurrence; Vb. 5-year distant recurrence; Vc. 5-year disease-free survival (DFS); Vd. 5-year overall survival (OS). EXPLORATORY OBJECTIVES: I. To evaluate patient-reported quality-of-life (QoL). II. To evaluate volumetric and dosimetric factors associated with acceptable breast cosmesis. III. To evaluate volumetric and dosimetric factors associated with acute and late radiation-associated toxicities. OUTLINE: Patients undergo UF-WBI with CB once daily (QD) on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo cone-beam computed tomography (CBCT) prior to each radiation treatment. After completion of study treatment, patients are followed up at 1 month, 6 months, then annually for up to 5 years.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Cone-Beam Computed Tomography	Undergo CBCT
RADIATION	Hypofractionated External Beam Radiation Therapy	Undergo UF-WBI with CB
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Boost	Undergo UF-WBI with CB
RADIATION	Whole Breast Irradiation	Undergo UF-WBI with CB

Timeline

• Start date: 2025-08-28
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2025-05-02
• Last updated: 2025-10-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study