City of Hope Medical Center
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 This has now been replaced by moderate hypofractionated radiation.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.
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer Ajc V8
Anatomic Stage III Breast Cancer AJCC v8
Breast Carcinoma
Cone-Beam Computed Tomography
Hypofractionated External Beam Radiation Therapy
Questionnaire Administration
Radiation Boost
Whole Breast Irradiation
PHASE2
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 82 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost |
| Actual Study Start Date : | 2025-10-05 |
| Estimated Primary Completion Date : | 2026-03-24 |
| Estimated Study Completion Date : | 2026-03-24 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
City of Hope at Arcadia
Arcadia, California, United States, 91007
Not yet recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Not yet recruiting
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Not yet recruiting
City of Hope Antelope Valley
Lancaster, California, United States, 93534
Not yet recruiting
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Not yet recruiting
City of Hope Upland
Upland, California, United States, 91786