Breast CancerPhase 2NCT06677944
Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer
A Phase 2 study testing Preoperative PBI in people with Breast Cancer and Ductal Carcinoma in Situ, run by Yonsei University at 1 site in South Korea.
Trial summary
In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma in Situ, Invasive Breast Cancer
- What is being tested?
- Preoperative PBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2023to 12 Oct 2026
- Phase
- Phase 2
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast cancer.
- Age ≥ 45
- cT1/cN0, tumor size ≤ 2.5cm
- ECOG 0~2 -ER+, HER2-
Who cannot join
- cN+
- Tumor located too close to the skin or chest wall (within 5 mm)
- With previous treatment history for breast cancer
- Neoadjuvant chemotherapy
- Multicentric disease
- Diffuse microcalcification
Show all 9Show fewer
- BRCA mutation
- Paget's disease
- In cases where tumor delineation is not achievable on CT/MRI images
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
Department of Radiation Oncology, Yonsei University College of Medicine
Seoul
Yong Bae Kim, ybkim3@yuhs.ac
About this study
Official title: Impact of Preoperative Stereotactic Partial Breast Irradiation on Treatment Response, Treatment-related Toxicity, and Cosmetic Outcomes in Early-stage Breast Cancer: A Prospective, Phase II Clinical Trial
In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy techniques, and delineation of the radiation field. Hypofractionated radiotherapy has been reported in numerous randomized phase 3 studies to show equivalent tumor control rates, reduced acute side effects, and similar late side effects compared to conventional fractionation. Among hypofractionated radiotherapy approaches, particularly in early-breast cancer, accelerated partial breast irradiation (APBI) may be chosen over whole breast irradiation (WBI). This approach is based on data indicating that the majority of local recurrences in breast cancer occur around the site of the primary tumor. By targeting radiation to the involved breast region, it becomes possible to increase the dose per fraction while shortening the overall treatment duration due to the smaller radiation treatment volume. While careful patient selection is crucial, multiple clinical studies have demonstrated that APBI, particularly after breast-conserving surgery, yields satisfactory local control rates comparable to WBI. This is accompanied by reduced side effects, improved convenience, enhanced quality of life, and potential cost savings.
Traditionally, APBI has been administered after surgery, but there is a recent trend to explore preoperative APBI. The rationale for performing preoperative APBI includes several considerations. Firstly, compared to postoperative APBI, the precise location of visually identifiable tumors allows for more accurate and targeted radiation therapy, minimizing the impact on adjacent normal tissues and achieving superior cosmetic results. Secondly, reducing the size of the preoperative lesion may enable more conservative surgery, decreasing the extent of the surgical procedure. Thirdly, it can serve as a preparatory treatment to assess tumor responsiveness. Fourthly, in some cases, it may be administered for definitive purposes, especially in elderly or frail women who may find it challenging to undergo standard treatment due to concurrent health issues.
Several clinical studies have reported the effectiveness and validity of preoperative PBI in a few cases of early breast cancer. These studies have shown low rates of acute and chronic toxicity, with excellent cosmetic outcomes. While accumulating evidence supports preoperative PBI, there is currently a lack of comparative studies with postoperative PBI. Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and postoperative PBI in early breast cancer patients.
Read the detailed description
This study is a phase II clinical trial consisting of a single experimental group (preoperative PBI group).
- Experimental Group: Preoperative Partial Breast Irradiation (Preoperative PBI)
The objective is to prove that preoperative partial breast irradiation (PBI) is not inferior in terms of radiotherapy-related side effects compared to postoperative PBI in early breast cancer patients.
Treatment outcomes, treatment-related complications, quality of life, degree of breast fibrosis, and breast aesthetics will be prospectively observed. Up to 47 patients will be enrolled over a period of 2 years, with a maximum follow-up observation of 1 years.
Evaluation of acute radiotherapy-related complications will be conducted at least once within 2 weeks from the start of radiotherapy. Additional assessments for acute complications and surgery-related complications will be performed at least once after 6 months of radiotherapy. Evaluation of late radiotherapy-related complications will occur 12 months after radiotherapy.
Patient's quality of life will be measured using self-reported questionnaires at (1) before radiotherapy, (2) 6 months after radiotherapy, and (3) 12 months after radiotherapy.
Breast aesthetics assessment using BCCT. Score software will be conducted at (1) before radiotherapy, (2) 6 months after radiotherapy, and (3) 12 months after radiotherapy. Evaluation of breast fibrosis will utilize the Tissue Compliance Meter device at (1) before radiotherapy, (2) 6 months after radiotherapy, and (3) 12 months after radiotherapy.
Preoperative PBI will be administered within 6 weeks of the patient's first registration, and surgery will be performed within 8 to 12 weeks after radiotherapy. Throughout radiotherapy, immediate, post-treatment, and follow-up observations at 6-month to 1-year intervals for up to 1 years will assess complications, surgical outcomes, cosmetic effects, and disease status.
- Being tested
- Preoperative PBI
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative PBIRadiation
Preoperative PBI: 21 Gy * 1 fraction Preoperative PBI is administered within 6 weeks of the patient's initial registration, and surgery is scheduled within 8 to 12 weeks after PBI.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative PBI | Experimental | PBI before surgery Receives: Radiation: Preoperative PBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of grade 2 or higher acute toxicities
The grade of toxicities should be evaluated according to CTCAE version 5.0.
Measured: Within 6 months after the start of radiotherapy
Secondary outcomes (10)
Pathologic complete response (CR) rate
Measured: At the time of surgery
Rate of any grade acute toxicities
Measured: Within 6 months after the start of radiotherapy
Rate of any gade late toxicities
Measured: 6 months after the start of radiotherapy
Rate of grade 2 or higher late toxicities
Measured: 6 months after the start of radiotherapy
BCCT.core software score
Measured: Baseline (before radiotherapy), at 6 months, 12 months after radiotherapy
Change of Quality of life score
Measured: Baseline (before radiotherapy), at 6 months, 12 months after radiotherapy
Tissue compliance meter score
Measured: Baseline (before radiotherapy), at 6 months, 12 months after radiotherapy
Disease-free survival
Measured: 12 months
overall survival
Measured: 12 months
breast cancer specific survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start13 Oct 2023
- Primary completion12 Oct 2025 (estimated)
- Study completion12 Oct 2026 (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.
- More trials run by Yonsei UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Bae Kim, Principal investigator, Department of Radiation Oncology, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677944
- Sponsor's protocol ID
- 4-2023-1112
- Status last verified
- Nov 2024
- First submitted
- 23 Jan 2024
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Stereotactic Partial Breast Irradiation on Treatment Response, Treatment-related Toxicity, and Cosmetic Outcomes in Early-stage Breast Cancer: A Prospective, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06677944
- Acronym / sponsor ID
- 4-2023-1112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 12 Oct 2025 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 7 Nov 2024 (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.
In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy techniques, and delineation of the radiation field. Hypofractionated radiotherapy has been reported in numerous randomized phase 3 studies to show equivalent tumor control rates, reduced acute side effects, and similar late side effects compared to conventional fractionation. Among hypofractionated radiotherapy approaches, particularly in early-breast cancer, accelerated partial breast irradiation (APBI) may be chosen over whole breast irradiation (WBI). This approach is based on data indicating that the majority of local recurrences in breast cancer occur around the site of the primary tumor. By targeting radiation to the involved breast region, it becomes possible to increase the dose per fraction while shortening the overall treatment duration due to the smaller radiation treatment volume. While careful patient selection is crucial, multiple clinical studies have demonstrated that APBI, particularly after breast-conserving surgery, yields satisfactory local control rates comparable to WBI. This is accompanied by reduced side effects, improved convenience, enhanced quality of life, and potential cost savings.
Traditionally, APBI has been administered after surgery, but there is a recent trend to explore preoperative APBI. The rationale for performing preoperative APBI includes several considerations. Firstly, compared to postoperative APBI, the precise location of visually identifiable tumors allows for more accurate and targeted radiation therapy, minimizing the impact on adjacent normal tissues and achieving superior cosmetic results. Secondly, reducing the size of the preoperative lesion may enable more conservative surgery, decreasing the extent of the surgical procedure. Thirdly, it can serve as a preparatory treatment to assess tumor responsiveness. Fourthly, in some cases, it may be administered for definitive purposes, especially in elderly or frail women who may find it challenging to undergo standard treatment due to concurrent health issues.
Several clinical studies have reported the effectiveness and validity of preoperative PBI in a few cases of early breast cancer. These studies have shown low rates of acute and chronic toxicity, with excellent cosmetic outcomes. While accumulating evidence supports preoperative PBI, there is currently a lack of comparative studies with postoperative PBI. Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and postoperative PBI in early breast cancer patients.
Detailed description
This study is a phase II clinical trial consisting of a single experimental group (preoperative PBI group).
- Experimental Group: Preoperative Partial Breast Irradiation (Preoperative PBI)
The objective is to prove that preoperative partial breast irradiation (PBI) is not inferior in terms of radiotherapy-related side effects compared to postoperative PBI in early breast cancer patients.
Treatment outcomes, treatment-related complications, quality of life, degree of breast fibrosis, and breast aesthetics will be prospectively observed. Up to 47 patients will be enrolled over a period of 2 years, with a maximum follow-up observation of 1 years.
Evaluation of acute radiotherapy-related complications will be conducted at least once within 2 weeks from the start of radiotherapy. Additional assessments for acute complications and surgery-related complications will be performed at least once after 6 months of radiotherapy. Evaluation of late radiotherapy-related complications will occur 12 months after radiotherapy.
Patient's quality of life will be measured using self-reported questionnaires at (1) before radiotherapy, (2) 6 months after radiotherapy, and (3) 12 months after radiotherapy.
Breast aesthetics assessment using BCCT. Score software will be conducted at (1) before radiotherapy, (2) 6 months after radiotherapy, and (3) 12 months after radiotherapy. Evaluation of breast fibrosis will utilize the Tissue Compliance Meter device at (1) before radiotherapy, (2) 6 months after radiotherapy, and (3) 12 months after radiotherapy.
Preoperative PBI will be administered within 6 weeks of the patient's first registration, and surgery will be performed within 8 to 12 weeks after radiotherapy. Throughout radiotherapy, immediate, post-treatment, and follow-up observations at 6-month to 1-year intervals for up to 1 years will assess complications, surgical outcomes, cosmetic effects, and disease status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative PBI | Experimental | Radiation: Preoperative PBIPBI before surgery |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast cancer.
- Age ≥ 45
- cT1/cN0, tumor size ≤ 2.5cm
- ECOG 0~2 -ER+, HER2-
Key exclusion criteria (9 listed)
- cN+
- Tumor located too close to the skin or chest wall (within 5 mm)
- With previous treatment history for breast cancer
- Neoadjuvant chemotherapy
- Multicentric disease
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 |
|---|---|---|
| Preoperative PBIPreoperative PBI: 21 Gy * 1 fraction Preoperative PBI is administered within 6 weeks of the patient's initial registration, and surgery is scheduled within 8 to 12 weeks after PBI. | Radiation | Preoperative PBI |
Primary outcome
Rate of grade 2 or higher acute toxicities
Time frame: Within 6 months after the start of radiotherapy
The grade of toxicities should be evaluated according to CTCAE version 5.0.
10 secondary outcomes
Pathologic complete response (CR) rate
Time frame: At the time of surgery
Rate of any grade acute toxicities
Time frame: Within 6 months after the start of radiotherapy
Rate of any gade late toxicities
Time frame: 6 months after the start of radiotherapy
Rate of grade 2 or higher late toxicities
Time frame: 6 months after the start of radiotherapy
BCCT.core software score
Time frame: Baseline (before radiotherapy), at 6 months, 12 months after radiotherapy
Change of Quality of life score
Time frame: Baseline (before radiotherapy), at 6 months, 12 months after radiotherapy
Tissue compliance meter score
Time frame: Baseline (before radiotherapy), at 6 months, 12 months after radiotherapy
Disease-free survival
Time frame: 12 months
overall survival
Time frame: 12 months
breast cancer specific survival
Time frame: 12 months
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 7 Nov 2024.
- 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.
Yong Bae Kim principal investigator
Department of Radiation Oncology, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative PBI in people with Breast Cancer and Ductal Carcinoma in Situ, run by Yonsei University 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 4 inclusion and 9 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 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yong Bae Kim (82-2-2228-8106, ybkim3@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of grade 2 or higher acute toxicities (time frame: Within 6 months after the start of radiotherapy). 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 7 Nov 2024.