Back to resultsRadiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer (RADAPT-N3)
Primary Purpose
Breast Cancer Stage III
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Whole breast / chest wall & regional lymph node irradiation
Internal mammary or supraclavicular lymph node boost
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Stage III
Eligibility Criteria
Inclusion Criteria: Female with age 19 or older Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy Underwent neoadjuvant chemotherapy Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy Eastern Cooperative Oncology Group performance status 0-2 Informed consent Exclusion Criteria: Previous history of radiation therapy to the chest Distant metastasis
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Postoperative radiation therapy to breast / chest wall and regional lymph node area
Arm Description
Patient achieved complete response after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 53.6 Gy in 16 fractions. Patient with partial response, stable disease, or progressive disease after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 56.0 Gy in 16 fractions.
Outcomes
Primary Outcome Measures
5-year disease-free survival
The event for disease-free survival is defined as any disease recurrence or breast cancer-related death
Secondary Outcome Measures
5-year overall survival
The event for overall survival is defined as death of patient with any cause.
5-year locoregional recurrence
The event for locoregional recurrence is defined as disease recurrence in irradiated breast / chest wall and/or regional lymph node area including internal mammary and supraclavicular lymph node area.
Adverse events
Adverse events after radiation therapy is graded according to CTCAE version 5.0.
Quality of life (BREAST-Q™)
Quality of life is assessed by BREAST-Q™ questionnaires. Each score from BREAST-Q™ scales ranges from 0 to 100. Higher scores reflect a better outcome except Cancer Worry scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05896865
Brief Title
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
Acronym
RADAPT-N3
Official Title
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
March 16, 2025 (Anticipated)
Study Completion Date
March 16, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy.
The main questions it aims to answer are:
5-year disease-free survival
5-year overall survival
5-year locoregional recurrence
Adverse events after radiation therapy
Quality of life
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
Disease status evaluation including physical and radiological examination
Quality of life assessment with questionnaires (BREAST-Q)
Adverse event assessment according to CTCAE version 5.0
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stage III
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Postoperative radiation therapy to breast / chest wall and regional lymph node area
Arm Type
Experimental
Arm Description
Patient achieved complete response after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 53.6 Gy in 16 fractions.
Patient with partial response, stable disease, or progressive disease after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 56.0 Gy in 16 fractions.
Intervention Type
Radiation
Intervention Name(s)
Whole breast / chest wall & regional lymph node irradiation
Intervention Description
Whole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions
Intervention Type
Radiation
Intervention Name(s)
Internal mammary or supraclavicular lymph node boost
Intervention Description
Simultaneous boost to Internal mammary or supraclavicular lymph node area with dose of total 53.6 Gy or 56.0 Gy in 16 fractions, depending on the response after neoadjuvant chemotherapy
Primary Outcome Measure Information:
Title
5-year disease-free survival
Description
The event for disease-free survival is defined as any disease recurrence or breast cancer-related death
Time Frame
5 years from the initiation of the radiation therapy
Secondary Outcome Measure Information:
Title
5-year overall survival
Description
The event for overall survival is defined as death of patient with any cause.
Time Frame
5 years from the initiation of the radiation therapy
Title
5-year locoregional recurrence
Description
The event for locoregional recurrence is defined as disease recurrence in irradiated breast / chest wall and/or regional lymph node area including internal mammary and supraclavicular lymph node area.
Time Frame
5 years from the initiation of the radiation therapy
Title
Adverse events
Description
Adverse events after radiation therapy is graded according to CTCAE version 5.0.
Time Frame
5 years from the initiation of the radiation therapy
Title
Quality of life (BREAST-Q™)
Description
Quality of life is assessed by BREAST-Q™ questionnaires. Each score from BREAST-Q™ scales ranges from 0 to 100. Higher scores reflect a better outcome except Cancer Worry scale.
Time Frame
5 years from the initiation of the radiation therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female with age 19 or older
Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy
Underwent neoadjuvant chemotherapy
Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy
Eastern Cooperative Oncology Group performance status 0-2
Informed consent
Exclusion Criteria:
Previous history of radiation therapy to the chest
Distant metastasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haeyoung Kim, MD, PhD
Phone
82-2-3410-2612
Email
haeyoung0131.kim@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haeyoung Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haeyoung Kim, MD, PhD
Phone
82-2-3410-2612
Email
haeyoung0131.kim@samsung.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
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