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Trial Title:
Neoadjuvant Radiotherapy for Breast Cancer
NCT ID:
NCT06313073
Condition:
Neoadjuvant Radiotherapy
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
neoadjuvant radiotherapy
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Neoadjuvant radiotherapy
Description:
The patient received synchronous radiotherapy and chemotherapy before surgery. CTV :
40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.CTV : 40Gy/15fx/3w, sequential GTV：
8.7-10Gy/3-4 Fx.
Arm group label:
Neoadjuvant radiotherapy
Intervention type:
Radiation
Intervention name:
adjuvant radiotherapy
Description:
The patient received radiotherapy after surgery. CTV : 40Gy/15fx/3w, sequential GTV：
8.7-10Gy/3-4 Fx.CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.
Arm group label:
Adjuvant radiotherapy
Summary:
The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and
adjuvant radiotherapy in patients with breast cancer.
The main questions it aims to answer are:
- The clinical effect of neoadjuvant radiotherapy for breast cancer was determined
according to the postoperative specimens.
- Evaluate the acute and late toxicity of preoperative radiotherapy Participants will
be randomly divided into two groups: the neoadjuvant radiotherapy group and the
adjuvant radiotherapy group.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female;
- Age range from 18 to 70 years old;
- The pathological diagnosis is invasive cancer, and immunohistochemical examination
has been performed to confirm the status of ER, PR, HER2, Ki67, etc;
- Clarify the BRCA gene mutation status;
- Patients who have a baseline stage of T1-3N0-3M0 and meet one of the following
conditions and require neoadjuvant therapy: ① mass>5cm; ② Axillary lymph node
metastasis; ③ HER-2 positive; ④ Three Yin type; ⑤ Those who have a desire to
preserve breast, but have a large ratio of tumor size to breast volume, making it
difficult to preserve breast;
- Baseline estimation requires adjuvant radiotherapy, which meets one of the following
conditions: ① performing breast conserving surgery; ② T3 or N positive patients
after mastectomy and axillary dissection; ③ After mastectomy, sentinel lymph nodes
were positive and axillary dissection was not performed;
- KPS score ≥ 80;
- The tumor must be visible in CT scan;
- Patients must undergo magnetic resonance imaging to help determine the contour of
the tumor and exclude other lesions. If other lesions are found, biopsy must be
performed on these lesions and the result is negative before continuing treatment;
- No history of serious internal medicine diseases or other serious comorbidities,
such as a history of mental illness, allergies, etc;
- Sign an informed consent form.
Exclusion Criteria:
- Clinical or pathological stage T4 or M1 breast cancer;
- Received preoperative neoadjuvant therapy;
- Pathological confirmation shows that there is no invasive cancer component in DCIS;
- Double breast cancer or previous contralateral breast cancer;
- Imaging examination suggests suspicious malignant lesions in the ipsilateral or
contralateral breast, which have not been pathologically confirmed to be benign;
- KPS score ≤ 70;
- There is active infection currently;
- Concomitant with severe heart, liver, kidney, hematopoietic and neurological
diseases, psychiatric patients, or estimated survival time<6 months;
- History of malignant tumors in other areas, excluding curable non melanoma skin
cancer and cervical cancer in situ;
- History of radiation therapy at the site of previous radiation therapy;
- Pregnancy and lactation period;
- Those with poor compliance or life-threatening conditions who cannot complete
treatment.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Huojun Zhang, M.D.
Phone:
+8613311732399
Email:
chyyzhj@163.com
Investigator:
Last name:
Huojun Zhang, M.D.
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
February 15, 2026
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313073
