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A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN) (BIRKIN)

Primary Purpose

Breast Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast cancer, MRI guided radiotherapy, Pre-operative radiotherapy, Ultra-hypofractionation

Eligibility Criteria

undefined - 55 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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; 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. Exclusion Criteria: 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).

Sites / Locations

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

preoperative tumor-bed boost

Arm Description

The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Local recurrence rate
The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast.
Local regional recurrence rate
The incidence of recurrence in the ipsilateral breast or the lymphatic nodal regions.
Disease-free survival
The time interval from diagnosis to any event of recurrence or death.
Overall survival
The time interval from diagnosis to death from any reason.
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.
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.
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.
Cosmetic outcome Breast Cancer Treatment Outcome Scale (BCTOS)
Cosmetic outcome Body Image Scale (BIS)

Full Information

First Posted
October 22, 2022
Last Updated
November 1, 2022
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05603078
Brief Title
A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)
Acronym
BIRKIN
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
July 19, 2026 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast cancer, MRI guided radiotherapy, Pre-operative radiotherapy, Ultra-hypofractionation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preoperative tumor-bed boost
Arm Type
Experimental
Arm Description
The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI.
Intervention Type
Radiation
Intervention Name(s)
Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
Description
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.
Time Frame
until 4 weeks of postoperative radiotherapy
Secondary Outcome Measure Information:
Title
Local recurrence rate
Description
The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast.
Time Frame
Until 5 years after diagnosis.
Title
Local regional recurrence rate
Description
The incidence of recurrence in the ipsilateral breast or the lymphatic nodal regions.
Time Frame
Until 5 years after diagnosis.
Title
Disease-free survival
Description
The time interval from diagnosis to any event of recurrence or death.
Time Frame
Until 5 years after diagnosis.
Title
Overall survival
Description
The time interval from diagnosis to death from any reason.
Time Frame
Until 5 years after diagnosis.
Title
Complications of surgery in the short term.
Description
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.
Time Frame
Until 30 days after the surgery.
Title
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC QLQ-C30
Description
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.
Time Frame
Until 5 years after treatment.
Title
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC BR-23
Description
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.
Time Frame
Until 5 years after treatment.
Title
Cosmetic outcome Breast Cancer Treatment Outcome Scale (BCTOS)
Time Frame
Until 5 years after treatment.
Title
Cosmetic outcome Body Image Scale (BIS)
Time Frame
Until 5 years after treatment.

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Dong, M.D.
Phone
+861087787678
Email
howelu1349@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Jing, M.D.
Phone
+861087788281
Email
owletskim@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Wang, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shu-lian Wang, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hao Jing, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiang-yi Kong, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Jing, M.D.
Phone
+861087788281
Email
owletskim@163.com
First Name & Middle Initial & Last Name & Degree
Hao Dong, M.D.
Phone
+861087787678
Email
howelu1349@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)

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