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

Primary Purpose

Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage 0 Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Radiation Therapy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Breast Carcinoma In Situ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Huntsman Cancer Institute/University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (hypofractionated radiation therapy)

Arm Description

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

Outcomes

Primary Outcome Measures

Breast photographic cosmetic scores
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
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
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
We will report the incidence of recurrence
Cost-effectiveness (CE) of hypofractionated radiation versus standard fractionation
Will be explored using cost data and quality adjusted life years (QALYs)

Full Information

First Posted
November 6, 2017
Last Updated
June 14, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03345420
Brief Title
Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (hypofractionated radiation therapy)
Arm Type
Experimental
Arm Description
Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiation Therapy
Other Intervention Name(s)
Hypofractionated Radiotherapy, hypofractionation
Intervention Description
Undergo hypofractionated radiation therapy
Primary Outcome Measure Information:
Title
Breast photographic cosmetic scores
Description
The scale used will be the modified EORTC Cosmetic Rating System of the treated compared to the untreated breast
Time Frame
Up to 24 months post radiation therapy (RT)
Secondary Outcome Measure Information:
Title
Breast-Q patient reported outcomes (PROs) scores
Description
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.
Time Frame
Scores at 6 months and 24 months post RT
Title
Incidence of acute and late radiation complications based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity
Description
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.
Time Frame
Up to 5 years
Title
Local and local regional recurrence rate
Description
We will report the incidence of recurrence
Time Frame
Up to 60 months
Title
Cost-effectiveness (CE) of hypofractionated radiation versus standard fractionation
Description
Will be explored using cost data and quality adjusted life years (QALYs)
Time Frame
Up to 24 months post RT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Horstmeier
Phone
801-587-4655
Email
Ashley.Horstmeier@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Poppe
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marissa Muse
Phone
801-587-9834
Email
marissa.muse@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Matthew M. Poppe

12. IPD Sharing Statement

Plan to Share IPD
No

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

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