Back to resultsNeoadjuvant Radiation in Locally Advanced Breast Cancer
Primary Purpose
Breast Neoplasms
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring breast cancer, neoadjuvant radiotherapy, biomarkers
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced breast carcinoma
- Inoperable with with 4-6 courses of prior chemotherapy
- No contradiction of radiation or chemo-radiotherapy
- Patients should have the ability to understand and the willingness to sign a written informed consent document
- Signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria:
- Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS
- Coagulation disorders
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
- Serious underlying medical illness with life expectancy less than 2 years.
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant radiotherapy
Arm Description
Group 1:Patients undergo mastectomy or Breast conserving surgery after radiotherapy Group 2:Patients receive boost in the area of residual breast mass and regional lymph node. A total dose of 66Gy will be given.
Outcomes
Primary Outcome Measures
Pathological response rate
only for operable patients
Fbjective response rate(ORR)
for inoperable patients
Event free survival(EFS)
for all patients
Secondary Outcome Measures
Time to progression
including local-regional recurrence, disease-free survival, overall survival
Radiation Toxicity
using CTCAE 4.0 and RTOG classification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05479409
Brief Title
Neoadjuvant Radiation in Locally Advanced Breast Cancer
Official Title
Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
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
The purpose of this study is to determine whether neoadjuvant radiation therapy is effective in improving local-regional control and to explore predictors of response to treatment in inoperable breast cancer patients after 2-6 courses of neoadjuvant chemotherapy.
Detailed Description
RATIONALE: The optimal management of patients with locally advanced breast cancer(LABC) remains unknown. It is currently accepted that the administration of radiation therapy prior to surgery might result in higher surgery rate or improvement of clinical outcomes.
OUTLINE： This is a prospective phase II study. The purpose is to evaluate the effectiveness of neoadjuvant radiotherapy in combination with chemotherapy. The primary objective in this study is to assess clinical outcomes of these patients. A secondary objective in this study is to identify biomarkers and imaging parameters that can be used as early predictors of treatment response in women with locally advanced breast cancer. Fresh tumor tissue or fresh peripheral blood should be collected as the test sample and stored before treatment. Ultrasound spectroscopy including shear wave elastography parameters should be done before and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast cancer, neoadjuvant radiotherapy, biomarkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Preoperative radiotherapy and concurrent chemotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant radiotherapy
Arm Type
Experimental
Arm Description
Group 1:Patients undergo mastectomy or Breast conserving surgery after radiotherapy Group 2:Patients receive boost in the area of residual breast mass and regional lymph node. A total dose of 66Gy will be given.
Intervention Type
Radiation
Intervention Name(s)
Neoadjuvant radiotherapy
Intervention Description
radiation therapy combined with chemotherapy prior to surgery
Primary Outcome Measure Information:
Title
Pathological response rate
Description
only for operable patients
Time Frame
1 year
Title
Fbjective response rate(ORR)
Description
for inoperable patients
Time Frame
3 year
Title
Event free survival(EFS)
Description
for all patients
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Time to progression
Description
including local-regional recurrence, disease-free survival, overall survival
Time Frame
3 year
Title
Radiation Toxicity
Description
using CTCAE 4.0 and RTOG classification
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Biologic predictor for treatment response
Description
biopsies of the original tumor before treatment for future molecular biology studies in LABC
Time Frame
before treatment
Title
The role of ultrasound in predicting treatment response
Description
shear wave elastography(SWE) technology
Time Frame
before and 1 month after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced breast carcinoma
Inoperable with with 4-6 courses of prior chemotherapy
No contradiction of radiation or chemo-radiotherapy
Patients should have the ability to understand and the willingness to sign a written informed consent document
Signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria:
Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS
Coagulation disorders
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
Serious underlying medical illness with life expectancy less than 2 years.
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Yu
Phone
+86-021-64175590
Email
stephanieyxl@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Meng
Phone
+86 18121299532
Email
jademj@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoli Yu
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
Xiaoli Yu
Email
stephanieyxl@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Radiation in Locally Advanced Breast Cancer
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