Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hypofractionated partial breast irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, hypofractionated partial breast irradiation
Eligibility Criteria
Inclusion Criteria:
- Female
- Age≥ 50 years
- Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
- Negative surgical margins
- Pathologically confirmed invasive breast cancer
- A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
- Tumor bed is labeled with Titanium clips
- Received adjuvant hormonal treatment
- No adjuvant chemotherapy
- ECOG:0-1
- Written informed consent.
Exclusion Criteria:
- Age<50 years
- KPS<70
- Treated with neoadjuvant chemotherapy
- Treated or being treated with chemotherapy
- With severe comorbidity
- Previous breast cancer or other malignant tumor history
- Previous radiotherapy for breast or thorax
- Medical contraindication for radiotherapy
- Pregnant or nursing
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HF-PBI
Arm Description
Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.
Outcomes
Primary Outcome Measures
The change of breast cosmetic outcome
The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
Secondary Outcome Measures
Acute radiation-induced toxicity assessed by CTCAE v4.0
acute toxicity related to skin and lung
Late complications
Complications related to radiation treatment after more than 3 months.
Ipsilateral breast tumor recurrence rate
The pathological confirmed tumor recurrence in the same breast
Local-regional recurrence
Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.
Disease free survival
The interval from diagnosis to disease recurrence or death or last visit.
Overall survival
The interval from diagnosis to death or last visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03411174
Brief Title
Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
Official Title
Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
Detailed Description
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, hypofractionated partial breast irradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HF-PBI
Arm Type
Experimental
Arm Description
Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.
Intervention Type
Radiation
Intervention Name(s)
hypofractionated partial breast irradiation
Intervention Description
deliver 40Gy/15Fx to tumor bed areas
Primary Outcome Measure Information:
Title
The change of breast cosmetic outcome
Description
The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
Time Frame
Baseline, and three years after the completion of radiation therapy
Secondary Outcome Measure Information:
Title
Acute radiation-induced toxicity assessed by CTCAE v4.0
Description
acute toxicity related to skin and lung
Time Frame
3weeks, 5weeks,1 and 3 months after treatment beginning
Title
Late complications
Description
Complications related to radiation treatment after more than 3 months.
Time Frame
3 years
Title
Ipsilateral breast tumor recurrence rate
Description
The pathological confirmed tumor recurrence in the same breast
Time Frame
5 years
Title
Local-regional recurrence
Description
Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.
Time Frame
5 years
Title
Disease free survival
Description
The interval from diagnosis to disease recurrence or death or last visit.
Time Frame
5 years
Title
Overall survival
Description
The interval from diagnosis to death or last visit
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Age≥ 50 years
Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
Negative surgical margins
Pathologically confirmed invasive breast cancer
A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
Tumor bed is labeled with Titanium clips
Received adjuvant hormonal treatment
No adjuvant chemotherapy
ECOG:0-1
Written informed consent.
Exclusion Criteria:
Age<50 years
KPS<70
Treated with neoadjuvant chemotherapy
Treated or being treated with chemotherapy
With severe comorbidity
Previous breast cancer or other malignant tumor history
Previous radiotherapy for breast or thorax
Medical contraindication for radiotherapy
Pregnant or nursing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinli Ma, MD,PhD
Phone
+86 15221033376
Email
jinli.ma@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinli Ma, MD,PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinli Ma, MD,PhD
Phone
+86 15221033376
Email
jinli.ma@aliyun.com
12. IPD Sharing Statement
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Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
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