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

Breast Cancer Stage III Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896865
• Other study ID #: 2023-01-012
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: March 16, 2030

Study information

• Verified date: June 2023
• Source: Samsung Medical Center
• Contact: Haeyoung Kim, MD, PhD
• Phone: 82-2-3410-2612
• Email: haeyoung0131.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 16, 2030
• Est. primary completion date: March 16, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Stage III
• Breast Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year disease-free survival	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	5-year overall survival	The event for overall survival is defined as death of patient with any cause.	5 years from the initiation of the radiation therapy
Secondary	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.	5 years from the initiation of the radiation therapy
Secondary	Adverse events	Adverse events after radiation therapy is graded according to CTCAE version 5.0.	5 years from the initiation of the radiation therapy
Secondary	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.	5 years from the initiation of the radiation therapy