Breast NeoplasmsBIRKINNCT05603078
A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)
A study testing Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5) in people with Breast Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study explores the feasibility of preoperative single-dose tumor-bed boost followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Read more about this study
- Who is it for?
- Ages Up to 55 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2022to Jul 2028
- 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 Up to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with invasive breast cancer;
- cN0 based on clinical physical examination combined with at least two imaging tests, or axillary fine-needle biopsy proved pN0;
- Patients who plan to receive breast-conserving surgery or breast-conserving oncoplastic surgery;
- No distant metastasis;
- The primary tumour> 5mm from the skin, without invasion of the ribs or intercostal muscles;
- No neoadjuvant systemic therapy;
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- Patients who can tolerate MRI;
- Life expectancy ≥5 years;
- Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.);
- Patients are willing to cooperate to follow up;
- Patients should sign the informed consent;
- Women of childbearing age need effective contraception.
Who cannot join
- Concurrent active connective tissue disease;
- Patients who had radiotherapy to the ipsilateral breast or adjacent areas before;
- Other malignancies, which affect pateint life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1));
- Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Hao Jing, M.D., +861087788281, owletskim@163.com
Hao Dong, M.D., +861087787678, howelu1349@hotmail.com
About this study
Official title: A Prospective Study of Preoperative MRI Linac-based Tumor-bed Boost Followed by Breast-conservative Oncoplastic Surgery and Adjuvant Ultra-hypofractionated Whole Breast Radiotherapy for Early Stage Breast Cancer
This study explores the feasibility of preoperative single-dose tumor-bed boost followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Patients less than 55 years old, who are diagnosed with breast cancer and are eligible to recieve breast-conserving surgery are enrolled. Patients who are older than 55 years, with suspected regional lymph node metastasis are excluded. The primary end point are the acute toxicities within 4 weeks after adjuvant radiation. The secondary endpoints are oncologic outcomes, surgical complications within 30 days, late toxicities, patients' quality of life and cosmetic outcomes.
Read the detailed description
This is a prospective, non-controlled, feasitility study. The tumor-bed boost part of the radiotherpay is put forward, 7-14 days before the definitive surgery. A single dose of 10Gy is prescribed to the tumor bed. In order to identify the tumor accurately, MRI guided radiotherapy is applied under the MR-linac. The breast surgery is planned after recovery from radiation induced acute toxicity, within 14 days. The surgeons would undertake lumpectomy only or an additional oncoplastic surgery, with axillary nodal evaluation with sentinal nodal biopsy or dissection. After wound healing, postoperative whole breast radiotherapy is administered, within 6 weeks following surgery. The dose is 26Gy/5.2Gy/5 fractions. Adjuvant systemic therapy is held until the end of the radiotherapy, no more than 12 weeks from surgery implementation.
- Conditions
- Breast Neoplasms
- Being tested
- Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)
- Keywords
- Breast cancer, MRI guided radiotherapy, Pre-operative radiotherapy, Ultra-hypofractionation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)Radiation
Preoperative tumor-bed boost was performed under MRI Linac, and a single dose of 10Gy is prescribed. The postoperative radiotherapy of 26Gy/5.2Gy/5 fractions is within 6 weeks following surgery. Adjuvant chemotherapy, targeted therapy and endocrine therapy are initiated no more than 12 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| preoperative tumor-bed boost | Experimental | The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI. Receives: Radiation: Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
We will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin. The incidence of all the above is the primary outcome.
Measured: until 4 weeks of postoperative radiotherapy
Secondary outcomes (9)
Local recurrence rate
The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast.
Measured: Until 5 years after diagnosis.
Local regional recurrence rate
The incidence of recurrence in the ipsilateral breast or the lymphatic nodal regions.
Measured: Until 5 years after diagnosis.
Disease-free survival
The time interval from diagnosis to any event of recurrence or death.
Measured: Until 5 years after diagnosis.
Overall survival
The time interval from diagnosis to death from any reason.
Measured: Until 5 years after diagnosis.
Complications of surgery in the short term.
We will record the incidence of surgery assciated mobilidy events within 30 days, including bleeding, seroma, hematoma, wound dehiscence, flap necrosis, delayed wound healing, fat necrosis, wound infection, abscess and upper limb edema.
Measured: Until 30 days after the surgery.
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC QLQ-C30
European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life in different time points.
Measured: Until 5 years after treatment.
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC BR-23
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC BR-23 to record patients' quality of life in different time points.
Measured: Until 5 years after treatment.
Cosmetic outcome Breast Cancer Treatment Outcome Scale (BCTOS)
Measured: Until 5 years after treatment.
Cosmetic outcome Body Image Scale (BIS)
Measured: Until 5 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start21 Jun 2022
- Primary completion19 Jul 2026 (estimated)
- Study completionJul 2028 (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 Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAO JING, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jing Wang, M.D., Study chair, Cancer Institute and Hospital, Chinese Academy of Medical SciencesShu-lian Wang, M.D., Study chair, Cancer Institute and Hospital, Chinese Academy of Medical SciencesHao Jing, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesXiang-yi Kong, M.D., Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603078
- Sponsor's protocol ID
- NCC2021291
- Acronym
- BIRKIN
- Status last verified
- Oct 2022
- First submitted
- 22 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dong H, Jing H, Wang XY, Kong XY, Wang YP, Zhai YR, Che SN, Fang Y, Wang SL, Wang J. Exploring the feasibility of preoperative tumor-bed boost, oncoplastic surgery, and adjuvant radiotherapy schedule in early-stage breast cancer: a phase II clinical trial. Int J Surg. 2025 Jan 1;111(1):382-393. doi: 10.1097/JS9.0000000000002073.
PubMed 39264581
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Preoperative MRI Linac-based Tumor-bed Boost Followed by Breast-conservative Oncoplastic Surgery and Adjuvant Ultra-hypofractionated Whole Breast Radiotherapy for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05603078
- Acronym / sponsor ID
- BIRKIN / NCC2021291
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, MRI guided radiotherapy, Pre-operative radiotherapy, Ultra-hypofractionation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 19 Jul 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 2 Nov 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 explores the feasibility of preoperative single-dose tumor-bed boost followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Patients less than 55 years old, who are diagnosed with breast cancer and are eligible to recieve breast-conserving surgery are enrolled. Patients who are older than 55 years, with suspected regional lymph node metastasis are excluded. The primary end point are the acute toxicities within 4 weeks after adjuvant radiation. The secondary endpoints are oncologic outcomes, surgical complications within 30 days, late toxicities, patients' quality of life and cosmetic outcomes.
Detailed description
This is a prospective, non-controlled, feasitility study. The tumor-bed boost part of the radiotherpay is put forward, 7-14 days before the definitive surgery. A single dose of 10Gy is prescribed to the tumor bed. In order to identify the tumor accurately, MRI guided radiotherapy is applied under the MR-linac. The breast surgery is planned after recovery from radiation induced acute toxicity, within 14 days. The surgeons would undertake lumpectomy only or an additional oncoplastic surgery, with axillary nodal evaluation with sentinal nodal biopsy or dissection. After wound healing, postoperative whole breast radiotherapy is administered, within 6 weeks following surgery. The dose is 26Gy/5.2Gy/5 fractions. Adjuvant systemic therapy is held until the end of the radiotherapy, no more than 12 weeks from surgery implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative tumor-bed boost | Experimental | Radiation: Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI. |
Who may qualify
- Ages
- Up to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Patients diagnosed with invasive breast cancer;
- cN0 based on clinical physical examination combined with at least two imaging tests, or axillary fine-needle biopsy proved pN0;
- Patients who plan to receive breast-conserving surgery or breast-conserving oncoplastic surgery;
- No distant metastasis;
- The primary tumour> 5mm from the skin, without invasion of the ribs or intercostal muscles;
Key exclusion criteria (4 listed)
- Concurrent active connective tissue disease;
- Patients who had radiotherapy to the ipsilateral breast or adjacent areas before;
- Other malignancies, which affect pateint life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1));
- Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
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 MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)Preoperative tumor-bed boost was performed under MRI Linac, and a single dose of 10Gy is prescribed. The postoperative radiotherapy of 26Gy/5.2Gy/5 fractions is within 6 weeks following surgery. Adjuvant chemotherapy, targeted therapy and endocrine therapy are initiated no more than 12 weeks after surgery. | Radiation | preoperative tumor-bed boost |
Primary outcome
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
Time frame: until 4 weeks of postoperative radiotherapy
We will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin. The incidence of all the above is the primary outcome.
9 secondary outcomes
Local recurrence rate
Time frame: Until 5 years after diagnosis.
Local regional recurrence rate
Time frame: Until 5 years after diagnosis.
Disease-free survival
Time frame: Until 5 years after diagnosis.
Overall survival
Time frame: Until 5 years after diagnosis.
Complications of surgery in the short term.
Time frame: Until 30 days after the surgery.
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC QLQ-C30
Time frame: Until 5 years after treatment.
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC BR-23
Time frame: Until 5 years after treatment.
Cosmetic outcome Breast Cancer Treatment Outcome Scale (BCTOS)
Time frame: Until 5 years after treatment.
Cosmetic outcome Body Image Scale (BIS)
Time frame: Until 5 years after treatment.
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 2 Nov 2022.
- Derived from this study: PubMed 39264581Dong H, Jing H, Wang XY, Kong XY, Wang YP, Zhai YR, Che SN, Fang Y, Wang SL, Wang J. Exploring the feasibility of preoperative tumor-bed boost, oncoplastic surgery, and adjuvant radiotherapy schedule in early-stage breast cancer: a phase II clinical trial. Int J Surg. 2025 Jan 1;111(1):382-393. doi: 10.1097/JS9.0000000000002073.
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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.
Jing Wang, M.D. study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Shu-lian Wang, M.D. study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Hao Jing, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5) in people with Breast Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 12 inclusion and 4 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 2 Nov 2022. 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 China. 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 Hao Dong, M.D. (+861087787678, howelu1349@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree) (time frame: until 4 weeks of postoperative radiotherapy). 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 NCT05603078, 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 2 Nov 2022.