Phase 2
N=102
Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
Ductal Breast Carcinoma In Situ · Invasive Breast Carcinoma · Stage 0 Breast Cancer · Stage I Breast Cancer · Stage IA Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03345420 ↗Enrolled (actual)
102
Serious AEs
3.9%
Results posted
Feb 2024
Primary outcome: Primary: Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy — 17; 26; 24; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hypofractionated Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy |
17; 26; 24; 11 | — |
| SECONDARY Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint |
68.2; 79.6; 63.4; 69 | — |
| SECONDARY Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint |
77.9; 79.6; 63; 68.8 | — |
| SECONDARY Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity |
— | — |
| SECONDARY Local and Local Regional Recurrence Rate |
— | — |
| SECONDARY Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation |
— | — |
Summary
This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. 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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast
- Final pathologic Tis, T1-T3, all must be N0 and M0 status.
- Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia
- Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields
- Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation.
- Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =< 7 days prior to registration
- A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
- Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion Criteria
- Prior radiation therapy to the chest, neck or axilla
- Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
- History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
- Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
- Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable
- Co-existing medical conditions with life expectancy < 5 years
- Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
- Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
- Neuroendocrine carcinoma or sarcoma histology
- Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
Data sourced from ClinicalTrials.gov (NCT03345420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.