RadiotherapyPhase 3PORT-N1NCT05440149
The Postoperative Radiotherapy in N1 Breast Cancer Patients
A Phase 3 study testing No PMRT for mastectomy / No regional RT for BCS and PMRT for mastectomy / WBI + Regional RT for BCS in people with Radiotherapy and Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Radiotherapy, Breast Cancer
- What is being tested?
- No PMRT for mastectomy / No regional RT for BCS and PMRT for mastectomy / WBI + Regional RT for BCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2022to 31 Dec 2033
- Phase
- Phase 3
- 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
- Patients aged 19 years or older.
- A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
- Patient with stage pN1 after surgery on histopathologic examination.
- However, if mastectomy was performed, 5 or more nodes should be resected in the case of 1 positive node, and axillary lymph node dissection (ALND) should be performed in case of 2 or 3 positive nodes.
- Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
- Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
- Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2.
- Patients who agreed to participate in the study.
Who cannot join
- Patients who have received prior [neoadjuvant] chemotherapy.
- Patients receiving radiation therapy for salvage or palliative purposes.
- Patients with stage T4.
- Patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases.
- Male breast cancer patient.
- Patients who have previously received radiation therapy to the ipsilateral breast or supraclavicular region.
- Patients having a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer.
- Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or benign tumors based on histological diagnosis.
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
Seoul National University Hospital
Seoul, Jongro-gu, 03080
Bum-Sup Jang, MD. PhD., bigwiz83@snu.ac.kr
About this study
Official title: The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.
Read the detailed description
1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative breast cancer (TNBC) versus non-TNBC)
The control group:
- If patients received BCS, WBI+Regional RT
- If patients received mastectomy, PMRT
The experimental group:
- If patients received breast conserving surgery, WBI alone
- If patients received mastectomy, No PMRT
- Conditions
- Radiotherapy, Breast Cancer
- Being tested
- No PMRT for mastectomy / No regional RT for BCS, PMRT for mastectomy / WBI + Regional RT for BCS
- Keywords
- Breast Cancer, Radiotherapy, Omission, Breast Conserving Surgery, Mastectomy, TNM pathologic stage N1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No PMRT for mastectomy / No regional RT for BCSRadiation
- Regional RT includes high-tangent field, and can include undissected axilla.
- The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II.
- Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
PMRT for mastectomy / WBI + Regional RT for BCSRadiation
- Regional RT includes high-tangent field, and can include undissected axilla.
- The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II.
- Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
| Study group | Role | What they receive |
|---|---|---|
| The Control group | Active comparator | * If patients received mastectomy, post-mastectomy radiation therapy (PMRT) should be performed.
* If patients received breast conserving surgery (BCS), whole breast irradiation (WBI) + Regional radiotherapy (RT) should be performed. Receives: Radiation: PMRT for mastectomy / WBI + Regional RT for BCS |
| The Experimental group | Experimental | * If patients received mastectomy, No PMRT should be performed.
* If patients received BCS, WBI alone should be performed. Receives: Radiation: No PMRT for mastectomy / No regional RT for BCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.
Measured: 7-Year
Secondary outcomes (3)
Locoregional-Recurrence Free Survival
Time from randomization to recurrence of tumors in the ipsilateral chest wall, breast or regional lymph nodes (ipsilateral axillary/internal mammary/supraclavicular lymph nodes) or breast cancer-related death.
** Recurrence should be confirmed by histological diagnosis, but local recurrence can be diagnosed by clinical examination only when regional/remote or distant metastases already exist.
Measured: 7-Year
Distant Metastases Free Survival
Time from randomization to the development of distant metastases or breast cancer-related death.
Measured: 7-Year
Overall Survival
Time from randomization to the death due to any cause.
Measured: 7-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Hwan Shin, Seoul National University Hospital
- Investigators
- Kyung Hwan Shin, MD. PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440149
- Sponsor's protocol ID
- 0720222005
- Acronym
- PORT-N1
- Status last verified
- Nov 2024
- First submitted
- 27 Jun 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee TH, Chang JH, Jang BS, Kim JS, Kim TH, Park W, Kim YB, Kim SS, Han W, Lee HB, Shin KH. Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy. BMC Cancer. 2022 Nov 16;22(1):1179. doi: 10.1186/s12885-022-10285-0.
PubMed 36384573
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT05440149
- Acronym / sponsor ID
- PORT-N1 / 0720222005
- Conditions
- Radiotherapy, Breast Cancer
- Keywords
- Breast Cancer, Radiotherapy, Omission, Breast Conserving Surgery, Mastectomy, TNM pathologic stage N1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,106 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 30 Jun 2022 (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.
This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.
Detailed description
1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative breast cancer (TNBC) versus non-TNBC)
The control group:
- If patients received BCS, WBI+Regional RT
- If patients received mastectomy, PMRT
The experimental group:
- If patients received breast conserving surgery, WBI alone
- If patients received mastectomy, No PMRT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Control group | Active comparator | Radiation: PMRT for mastectomy / WBI + Regional RT for BCS* If patients received mastectomy, post-mastectomy radiation therapy (PMRT) should be performed. * If patients received breast conserving surgery (BCS), whole breast irradiation (WBI) + Regional radiotherapy (RT) should be performed. |
| The Experimental group | Experimental | Radiation: No PMRT for mastectomy / No regional RT for BCS* If patients received mastectomy, No PMRT should be performed. * If patients received BCS, WBI alone should be performed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 19 years or older.
- A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
- Patient with stage pN1 after surgery on histopathologic examination.
- Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
- Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
Key exclusion criteria (8 listed)
- Patients who have received prior [neoadjuvant] chemotherapy.
- Patients receiving radiation therapy for salvage or palliative purposes.
- Patients with stage T4.
- Patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases.
- Male breast cancer patient.
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 |
|---|---|---|
| No PMRT for mastectomy / No regional RT for BCS* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used. | Radiation | The Experimental group |
| PMRT for mastectomy / WBI + Regional RT for BCS* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used. | Radiation | The Control group |
Primary outcome
Disease-Free Survival
Time frame: 7-Year
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.
3 secondary outcomes
Locoregional-Recurrence Free Survival
Time frame: 7-Year
Distant Metastases Free Survival
Time frame: 7-Year
Overall Survival
Time frame: 7-Year
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 Nov 2024.
- Background: PubMed 36384573Lee TH, Chang JH, Jang BS, Kim JS, Kim TH, Park W, Kim YB, Kim SS, Han W, Lee HB, Shin KH. Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy. BMC Cancer. 2022 Nov 16;22(1):1179. doi: 10.1186/s12885-022-10285-0.
- Individual participant dataSharing planned: No
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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.
Kyung Hwan Shin, MD. PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing No PMRT for mastectomy / No regional RT for BCS and PMRT for mastectomy / WBI + Regional RT for BCS in people with Radiotherapy and Breast Cancer, run by Seoul National University Hospital 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 8 inclusion and 8 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 Nov 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kyung Hwan Shin, MD. PhD. (+82-2-2072-2524, radiat@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (time frame: 7-Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440149, which also lists 1 linked publication.
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 Nov 2024.