Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer

Phase 2

Active, not recruiting

Conditions: Invasive Breast Carcinoma
Stage IA Breast Cancer
Stage II Breast Cancer
Stage IIB Breast Cancer
Ductal Breast Carcinoma In Situ
Stage I Breast Cancer
Stage IB Breast Cancer
Stage 0 Breast Cancer
Stage IIA Breast Cancer

Brief 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.

Detailed Description: PRIMARY OBJECTIVES:

I. To evaluate 24 month breast photographic cosmetic scores with 9 fraction radiation compared to standard hypofractionation.

SECONDARY OBJECTIVES:

I. To evaluate Breast-Q patient reported outcomes (PROs) compared to historical control in breast conservation.

II. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.

III. To evaluate the local and local regional recurrence rate. IV. To compare the direct and indirect patient costs for radiation therapy compared to historical controls as well as quality adjusted life years, utilizing the Breast-Q Patient Reported Outcomes (PROs) and the EQ-5D.

OUTLINE:

Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.

After completion of study treatment, patients are followed up at 2-8 weeks, 6 months, and annually for 3 years.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment	Hypofractionated Radiation Therapy	Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.

Primary Outcome Measures

Name	Time	Method
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy	Up to 24 months post radiation therapy (RT)	The EORTC (European Organisation for Research and Treatment of Cancer) Breast Cosmetic Rating system is a blinded digital photographic method that compares the radiated breast with the contralateral untreated side and evaluates: Size, shape, location of the areola/nipple, appearance of the surgical scar, skin pigmentation changes, presence of telangiectasia and a global cosmetic score based on all of the factors. Characteristics are graded on a four-point scale: 0, excellent or no difference; 1, good or small difference; 2, fair or moderate difference; and 3, poor or large difference. Images taken at the 24 month timepoint were assessed by 3 unbiased reviewers including a radiation oncologist, surgeon and nurse. The data is presented as the count of participants meeting the overall rating criteria as assessed by these reviewers.

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation	Up to 3 years	Will be explored using cost data and quality adjusted life years (QALYs)
Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint	6 months post RT	* Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint	24 months post RT	* Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity	Up to 5 years	The proportion of patients with acute or late radiation complications, will be estimated. Any event longer than 3 months will be considered a late effect.
Local and Local Regional Recurrence Rate	Up to 60 months	We will report the incidence of recurrence

Locations (1): Huntsman Cancer Institute/University of Utah
🇺🇸
Salt Lake City, Utah, United States