Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer (RADAPT-N3)

June 8, 2023 updated by: Haeyoung Kim, Samsung Medical Center

Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postoperative radiation therapy to breast / chest wall and regional lymph node area

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.
Radiation: Whole breast / chest wall & regional lymph node irradiation
Whole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions
Radiation: Internal mammary or supraclavicular lymph node boost
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year disease-free survival
Time Frame: 5 years from the initiation of the radiation therapy
The event for disease-free survival is defined as any disease recurrence or breast cancer-related death
5 years from the initiation of the radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival
Time Frame: 5 years from the initiation of the radiation therapy
The event for overall survival is defined as death of patient with any cause.
5 years from the initiation of the radiation therapy
5-year locoregional recurrence
Time Frame: 5 years from the initiation of the radiation therapy
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.
5 years from the initiation of the radiation therapy
Adverse events
Time Frame: 5 years from the initiation of the radiation therapy
Adverse events after radiation therapy is graded according to CTCAE version 5.0.
5 years from the initiation of the radiation therapy
Quality of life (BREAST-Q™)
Time Frame: 5 years from the initiation of the radiation therapy
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.
5 years from the initiation of the radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Haeyoung Kim, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Estimated)

March 16, 2025

Study Completion (Estimated)

March 16, 2030

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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