Clinical trial NCT03345420: Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: 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
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
timeFrame: Up to 24 months post radiation therapy (RT)
Secondary outcomes:
measure: Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint
timeFrame: 6 months post RT
measure: Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint
timeFrame: 24 months post RT
measure: Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity
timeFrame: Up to 5 years
measure: Local and Local Regional Recurrence Rate
timeFrame: Up to 60 months
measure: Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Matthew Poppe
role: PRINCIPAL_INVESTIGATOR
References: