Breast CancerPhase 3NCT05993559
Necessity of Post-mastectomy Radiotherapy After Neoadjuvant Chemotherapy and Mastectomy
A Phase 3 study testing Arm I (No PMRT) and Arm II (PMRT) in people with Breast Cancer, run by Gangnam Severance Hospital.
Trial summary
Postoperative radiotherapy is generally recommended for patients with breast cancer who have undergone breast-conserving surgery, regardless of prior chemotherapy. However, the criteria for postoperative radiation therapy (PMRT) in patients with breast cancer who have received upfront chemotherapy and mastectomy… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arm I (No PMRT) and Arm II (PMRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,314 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2024to 10 Jul 2031
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 20 years of age or older with histologically confirmed invasive breast cancer.
- Patients with clinical stage IIB-III at the time of diagnosis (including cases of cT1N1 with multiple masses observed during clinical stage IIA). Patients are considered node positive if they have either suspected lymph node metastasis on imaging studies (U/S, breast MRI, PET-CT) or confirmed by pathology.
- Patients who have undergone mastectomy after prior neoadjuvant chemotherapy.
- Patients with pathologic complete response (pCR) or residual cancer burden (RCB) class 0-I based on postoperative pathology.
- Complete remission is defined as ypT0/is ypN0. RCB class 0 means complete remission and RCB class 1 is defined as an RCB score ≥0-1.36 as determined by the pathology department at the site.
- Patients not previously treated for invasive breast cancer.
- Patients with a systemic performance status of 0-2 based on ECOG.
- Patients who signed the informed consent prior to study entry.
Who cannot join
- Patients with a prior history of invasive breast cancer (patients with a prior history of intraepithelial carcinoma of the breast may be enrolled)
- Patients with bilateral breast cancer
- Patients with a prior diagnosis of cancer other than breast cancer within 5 years (however, adequately treated skin cancer other than melanoma and thyroid cancer are eligible for enrollment.)
- Patients with pathologically or imaging confirmed systemic metastases
- Patients with a history of prior irradiation or isotope therapy to the rib cage and axillary region contralateral to the breast cancer lesion
- Patients with suspected supraclavicular/infraclavicular lymph node metastases and internal mammary lymph node metastases
- Pregnant or lactating patients
- Patients who have difficulty understanding the contents of the consent form and completing the survey.
About this study
Official title: Necessity of Post-mastectomy Radiotherapy in Breast Cancer Patients With an Excellent Response After Neoadjuvant Chemotherapy: A Phase 3, Multicenter, Randomized Controlled Study
Postoperative radiotherapy is generally recommended for patients with breast cancer who have undergone breast-conserving surgery, regardless of prior chemotherapy. However, the criteria for postoperative radiation therapy (PMRT) in patients with breast cancer who have received upfront chemotherapy and mastectomy remain controversial. PMRT is recommended for patients with suspected axillary lymph node metastases before chemotherapy or residual cancer in the axillary lymph nodes after surgery, but this varies by institution and physician. In particular, breast cancer patients with a very good treatment response (pCR or RCB 0-I after prior chemotherapy) have a very good prognosis, and the question of whether PMRT is necessary for these patients continues to be raised. With the addition of new targeted therapies and immuno-oncology agents to conventional chemotherapy, the number of patients with good response is increasing, but there are no prospective studies to date.
The studies that have evaluated the need for PMRT in breast cancer patients with a very good treatment response after upfront chemotherapy and mastectomy are all retrospective studies, lacking evidence to apply to standard of care, and have different definitions of a good treatment response group. Therefore, in this study, the investigators aim to reduce unnecessary overtreatment by comparing survival between PMRT and no PMRT in breast cancer patients with a good response to prior chemotherapy and mastectomy, demonstrating non-inferiority of PMRT to no PMRT. By doing so, the investigators hope to reduce patients' side effects and discomfort, improve their satisfaction and quality of life, and contribute to a new standard of care.
The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT.
- Conditions
- Breast Cancer
- Being tested
- Arm I (No PMRT), Arm II (PMRT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (No PMRT)Radiation
The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT.
Arm II (PMRT)Radiation
The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT.
| Study group | Role | What they receive |
|---|---|---|
| No PMRT | Experimental | No radiation therapy after neoadjuvant chemotherapy and surgery. Receives: Radiation: Arm I (No PMRT) |
| PMRT | Placebo comparator | Arm Description: Proceed with postoperative radiotherapy, following the guidelines of the respective institution, but advising patients to apply the following points whenever possible.
* If radiation therapy is administered, include the chest wall and regional LNs.
* If PMRT field to regional LN, include Axillary LN level III, level IV, Internal mammary LN (1-3rd ICS). Receives: Radiation: Arm II (PMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year invasive disease free survival (iDFS)
Invasive disease-free survival is defined as first invasive recurrence (local, regional, or distant), second invasive cancer (contralateral breast or other cancer), or death from any cause from the date of enrollment.
Measured: 5 year
Secondary outcomes (4)
Overall survival
5-year overall survival (OS): Overall survival is defined as the time from subject enrollment to death from any cause.
Measured: 5 year
Locoregional recurrense free survival
5-year locoregional recurrence-free interval (LRFI): LRFI is defined as the time of first local recurrence of invasive breast cancer from date of enrollment.
Measured: 5 year
Distant metastasis free surviva
5-year distant metastasis-free survival (DMFS): Distant metastasis-free survival is defined as the time from enrollment to the i) first distant metastasis of breast cancer confirmed by imaging (biopsy is performed at the discretion of the investigator). ii) death from breast cancer. iii) death from unknown or non-breast cancer causes.
Measured: 5 year
Complications of radiotherapy
Information on radiotherapy complications including but not restricted to the following items will be collected and any examinations can be ordered at the discretion of the investigator if a patient presents symptoms:
- Neutropenia
- Cardiac disease: pericarditis, sinus tachycardia, angina, pericardial effusion, tamponade, cardiac enlargement, heart failure etc.
- Pulmonary disease: dry cough, dyspnea, pneumonitis etc.
- Lymphedema of the arm
- Skin symptoms: erythema, edema, ulceration, hemorrhage, necrosis etc.
- Esophageal disease: dysphagia, odynophagia, obstruction, ulceration, perforation, fistula etc.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start11 Nov 2024 (estimated)
- Primary completion10 Apr 2031 (estimated)
- Study completion10 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 1,314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Jeong, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993559
- Sponsor's protocol ID
- 3-2023-0178
- Status last verified
- Jan 2024
- First submitted
- 20 Jul 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necessity of Post-mastectomy Radiotherapy in Breast Cancer Patients With an Excellent Response After Neoadjuvant Chemotherapy: A Phase 3, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05993559
- Acronym / sponsor ID
- 3-2023-0178
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,314 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 11 Nov 2024 (estimated)
- Primary completion
- 10 Apr 2031 (estimated)
- Study completion
- 10 Jul 2031 (estimated)
- First posted
- 15 Aug 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.
Postoperative radiotherapy is generally recommended for patients with breast cancer who have undergone breast-conserving surgery, regardless of prior chemotherapy. However, the criteria for postoperative radiation therapy (PMRT) in patients with breast cancer who have received upfront chemotherapy and mastectomy remain controversial. PMRT is recommended for patients with suspected axillary lymph node metastases before chemotherapy or residual cancer in the axillary lymph nodes after surgery, but this varies by institution and physician. In particular, breast cancer patients with a very good treatment response (pCR or RCB 0-I after prior chemotherapy) have a very good prognosis, and the question of whether PMRT is necessary for these patients continues to be raised. With the addition of new targeted therapies and immuno-oncology agents to conventional chemotherapy, the number of patients with good response is increasing, but there are no prospective studies to date.
The studies that have evaluated the need for PMRT in breast cancer patients with a very good treatment response after upfront chemotherapy and mastectomy are all retrospective studies, lacking evidence to apply to standard of care, and have different definitions of a good treatment response group. Therefore, in this study, the investigators aim to reduce unnecessary overtreatment by comparing survival between PMRT and no PMRT in breast cancer patients with a good response to prior chemotherapy and mastectomy, demonstrating non-inferiority of PMRT to no PMRT. By doing so, the investigators hope to reduce patients' side effects and discomfort, improve their satisfaction and quality of life, and contribute to a new standard of care.
The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No PMRT | Experimental | Radiation: Arm I (No PMRT)No radiation therapy after neoadjuvant chemotherapy and surgery. |
| PMRT | Placebo comparator | Radiation: Arm II (PMRT)Arm Description: Proceed with postoperative radiotherapy, following the guidelines of the respective institution, but advising patients to apply the following points whenever possible. * If radiation therapy is administered, include the chest wall and regional LNs. * If PMRT field to regional LN, include Axillary LN level III, level IV, Internal mammary LN (1-3rd ICS). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients 20 years of age or older with histologically confirmed invasive breast cancer.
- Patients with clinical stage IIB-III at the time of diagnosis (including cases of cT1N1 with multiple masses observed during clinical stage IIA). Patients are considered node positive if they have either suspected lymph node metastasis on imaging studies (U/S, breast MRI, PET-CT) or confirmed by pathology.
- Patients who have undergone mastectomy after prior neoadjuvant chemotherapy.
- Patients with pathologic complete response (pCR) or residual cancer burden (RCB) class 0-I based on postoperative pathology.
- Complete remission is defined as ypT0/is ypN0. RCB class 0 means complete remission and RCB class 1 is defined as an RCB score ≥0-1.36 as determined by the pathology department at the site.
Key exclusion criteria (8 listed)
- Patients with a prior history of invasive breast cancer (patients with a prior history of intraepithelial carcinoma of the breast may be enrolled)
- Patients with bilateral breast cancer
- Patients with a prior diagnosis of cancer other than breast cancer within 5 years (however, adequately treated skin cancer other than melanoma and thyroid cancer are eligible for enrollment.)
- Patients with pathologically or imaging confirmed systemic metastases
- Patients with a history of prior irradiation or isotope therapy to the rib cage and axillary region contralateral to the breast cancer lesion
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 |
|---|---|---|
| Arm I (No PMRT)The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT. | Radiation | No PMRT |
| Arm II (PMRT)The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT. | Radiation | PMRT |
Primary outcome
5 year invasive disease free survival (iDFS)
Time frame: 5 year
Invasive disease-free survival is defined as first invasive recurrence (local, regional, or distant), second invasive cancer (contralateral breast or other cancer), or death from any cause from the date of enrollment.
4 secondary outcomes
Overall survival
Time frame: 5 year
Locoregional recurrense free survival
Time frame: 5 year
Distant metastasis free surviva
Time frame: 5 year
Complications of radiotherapy
Time frame: 5 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 12 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arm I (No PMRT) and Arm II (PMRT) in people with Breast Cancer, run by Gangnam Severance Hospital.
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: opening soon, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year invasive disease free survival (iDFS) (time frame: 5 year). 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 12 Jan 2024.