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

Stage II Breast Cancer Clinical Trial

— NOVEMBER  

Official title:

NOVEMBER (Novem- (9), BrEast Radiation), A Phase II Trial of a 9 Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03345420
• Other study ID #: HCI103976
• Secondary ID: NCI-2017-02018HC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 12, 2017
• Est. completion date: September 3, 2025

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: September 3, 2025
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Breast Carcinoma In Situ
• Invasive Breast Carcinoma
• Stage 0 Breast Cancer
• Stage I Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer

Intervention

Radiation:
• Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy	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.	Up to 24 months post radiation therapy (RT)
Secondary	Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint	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.	6 months post RT
Secondary	Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint	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.	24 months post RT
Secondary	Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity	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.	Up to 5 years
Secondary	Local and Local Regional Recurrence Rate	We will report the incidence of recurrence	Up to 60 months
Secondary	Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation	Will be explored using cost data and quality adjusted life years (QALYs)	Up to 3 years