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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorSamsung Medical Center

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous history of radiation therapy to the chest

Distant metastasis

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Postoperative radiation therapy to breast / chest wall and regional lymph node areaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

5-year disease-free survival

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 outcomes

1

5-year overall survival

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
2

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.

Time frame
5 years from the initiation of the radiation therapy
3

Adverse events

Adverse events after radiation therapy is graded according to CTCAE version 5.0.

Time frame
5 years from the initiation of the radiation therapy
4

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.

Time frame
5 years from the initiation of the radiation therapy

Other outcomes

Sponsors and contacts

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