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

Sponsor

University of Utah (Other)

Overall Status

Recruiting

CT.gov ID

NCT03345420

Collaborator

(none)

102

Enrollment

Location

Arm

71.6

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: Hypofractionated Radiation Therapy	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

To evaluate Breast-Q patient reported outcomes (PROs) compared to historical control in breast conservation.
To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 12, 2017

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (hypofractionated radiation therapy) Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.	Radiation: Hypofractionated Radiation Therapy Undergo hypofractionated radiation therapy Other Names: Hypofractionated Radiotherapy hypofractionation

Arm

Intervention/Treatment

Experimental: Treatment (hypofractionated radiation therapy)

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

Radiation: Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Other Names:

Hypofractionated Radiotherapy

hypofractionation

Outcome Measures

Primary Outcome Measures

Breast photographic cosmetic scores [Up to 24 months post radiation therapy (RT)]
The scale used will be the modified EORTC Cosmetic Rating System of the treated compared to the untreated breast

Secondary Outcome Measures

Breast-Q patient reported outcomes (PROs) scores [Scores at 6 months and 24 months post RT]
Will be using the Breast Q survey tool to assess patient-reported satisfaction with breast, well-being, and overall satisfaction. Scores at 6 months and 24 months post-radiation (relative to pre-RT) will be summarized and compared to prior published data, utilizing a two-sample t-test with a two-sided alternative.
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
Cost-effectiveness (CE) of hypofractionated radiation versus standard fractionation [Up to 24 months post RT]
Will be explored using cost data and quality adjusted life years (QALYs)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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