Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer
Primary Purpose
Breast Neoplasms, Neoplasm Recurrence, Local
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Accelerated Partial Breast Irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast conserving surgery, Accelerate partial breast irradiation, intensity-modulated radiation therapy, phase II
Eligibility Criteria
Inclusion Criteria:
- Life Expectation: > 5 years
- Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
- Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
- Unifocal tumour (confirmed by diagnostic MRI)
- No lymphovascular invasion
- ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
- Negative radial resection margins of >= 2 mm
- Surgical clips placed in the tumor bed
- Written informed consent.
Exclusion Criteria:
- Stage Ⅱ-Ⅲ
- Multifocal tumors
- Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
- Paget's disease of the nipple
- Underwent oncoplastic surgery of ipsilateral breast
- Underwent neoadjuvant chemotherapy or hormonal therapy
- Previous or simultaneous contralateral breast cancer
- Undergone ipsilateral chest wall radiotherapy
- Active collagen vascular disease.
Sites / Locations
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Accelerated Partial Breast Irradiation
Arm Description
Accelerated partial breast irradiation (APBI) to the region of tumour bed
Outcomes
Primary Outcome Measures
locoregional control rate
ipsilateral breast and axilla nodal relapse rate
Secondary Outcome Measures
overall survival
any death
disease-free survival
any recurrence or death
distant-metastasis survival
distant metastasis
Full Information
NCT ID
NCT03583580
First Posted
June 19, 2018
Last Updated
January 6, 2022
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03583580
Brief Title
Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer
Official Title
A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.
Detailed Description
This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Neoplasm Recurrence, Local
Keywords
Breast conserving surgery, Accelerate partial breast irradiation, intensity-modulated radiation therapy, phase II
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
537 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Accelerated Partial Breast Irradiation
Arm Type
Experimental
Arm Description
Accelerated partial breast irradiation (APBI) to the region of tumour bed
Intervention Type
Radiation
Intervention Name(s)
Accelerated Partial Breast Irradiation
Intervention Description
Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)
Primary Outcome Measure Information:
Title
locoregional control rate
Description
ipsilateral breast and axilla nodal relapse rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Description
any death
Time Frame
5 years
Title
disease-free survival
Description
any recurrence or death
Time Frame
5 years
Title
distant-metastasis survival
Description
distant metastasis
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
acute and late adverse events assessed by CTCAE v4.0
Description
acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result
Time Frame
5 years
Title
quality of life measured with BR-23 questionnaire
Description
BR-23 questionnaire
Time Frame
2 years
Title
the incidence of second malignancy
Description
pathologically diagnosis of contralateral breast cancer and other malignant tumors after radiotherapy
Time Frame
5 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female only
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Life Expectation: > 5 years
Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
Unifocal tumour (confirmed by diagnostic MRI)
No lymphovascular invasion
ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
Negative radial resection margins of >= 2 mm
Surgical clips placed in the tumor bed
Written informed consent.
Exclusion Criteria:
Stage Ⅱ-Ⅲ
Multifocal tumors
Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
Paget's disease of the nipple
Underwent oncoplastic surgery of ipsilateral breast
Underwent neoadjuvant chemotherapy or hormonal therapy
Previous or simultaneous contralateral breast cancer
Undergone ipsilateral chest wall radiotherapy
Active collagen vascular disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangyi Sun, M.D.
Phone
08618811100731
Email
sunliving@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shulian Wang, M.D.
Phone
8610-87788803
Email
wangsl@cicams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shulian Wang, M.D.
Organizational Affiliation
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-lian Wang, M.D.
First Name & Middle Initial & Last Name & Degree
Shulian Wang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer
We'll reach out to this number within 24 hrs