Mode
Text Size
Log in / Sign up
Phase 2 N=102 Treatment

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search