Breast Cancer Stage IIIRADAPT-N3NCT05896865
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
A study testing Whole breast / chest wall & regional lymph node irradiation and Internal mammary or supraclavicular lymph node boost in people with Breast Cancer Stage III, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer Stage III
- What is being tested?
- Whole breast / chest wall & regional lymph node irradiation and Internal mammary or supraclavicular lymph node boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2023to 16 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous history of radiation therapy to the chest
- Distant metastasis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Haeyoung Kim, MD, PhD, 82-2-3410-2612, haeyoung0131.kim@samsung.com
About this study
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
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:
Read more
- 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
- Conditions
- Breast Cancer Stage III
- Being tested
- Whole breast / chest wall & regional lymph node irradiation, Internal mammary or supraclavicular lymph node boost
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole breast / chest wall & regional lymph node irradiationRadiation
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 boostRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Postoperative radiation therapy to breast / chest wall and regional lymph node area | Experimental | 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. Receives: Radiation: Whole breast / chest wall & regional lymph node irradiation; Radiation: Internal mammary or supraclavicular lymph node boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year disease-free survival
The event for disease-free survival is defined as any disease recurrence or breast cancer-related death
Measured: 5 years from the initiation of the radiation therapy
Secondary outcomes (4)
5-year overall survival
The event for overall survival is defined as death of patient with any cause.
Measured: 5 years from the initiation of the radiation therapy
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.
Measured: 5 years from the initiation of the radiation therapy
Adverse events
Adverse events after radiation therapy is graded according to CTCAE version 5.0.
Measured: 5 years from the initiation of the radiation therapy
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.
Measured: 5 years from the initiation of the radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start16 Mar 2023
- Primary completion16 Mar 2028 (estimated)
- Study completion16 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haeyoung Kim, Samsung Medical Center
- Investigators
- Haeyoung Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896865
- Sponsor's protocol ID
- 2023-01-012
- Acronym
- RADAPT-N3
- Status last verified
- Jun 2025
- First submitted
- 31 May 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05896865
- Acronym / sponsor ID
- RADAPT-N3 / 2023-01-012
- Conditions
- Breast Cancer Stage III
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 16 Mar 2028 (estimated)
- Study completion
- 16 Mar 2030 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative radiation therapy to breast / chest wall and regional lymph node area | Experimental | Radiation: Whole breast / chest wall & regional lymph node irradiation, Radiation: Internal mammary or supraclavicular lymph node boostPatient 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Previous history of radiation therapy to the chest
- Distant metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole breast / chest wall & regional lymph node irradiationWhole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions | Radiation | Postoperative radiation therapy to breast / chest wall and regional lymph node area |
| Internal mammary or supraclavicular lymph node boostSimultaneous 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 | Radiation | Postoperative radiation therapy to breast / chest wall and regional lymph node area |
Primary outcome
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
4 secondary outcomes
5-year overall survival
Time frame: 5 years from the initiation of the radiation therapy
5-year locoregional recurrence
Time frame: 5 years from the initiation of the radiation therapy
Adverse events
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Stage III
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haeyoung Kim, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole breast / chest wall & regional lymph node irradiation and Internal mammary or supraclavicular lymph node boost in people with Breast Cancer Stage III, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haeyoung Kim, MD, PhD (82-2-3410-2612, haeyoung0131.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year disease-free survival (time frame: 5 years from the initiation of the radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.