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NCT Number: NCT05896865

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

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

Recruiting

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Key information

Conditions

Breast Cancer Stage III Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole breast / chest wall & regional lymph node irradiation

Radiation

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

Radiation

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haeyoung Kim, MD, PhD

CONTACT

[email protected]

82-2-3410-2612

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Acronym: RADAPT-N3

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Jun 9, 2023
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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