Neoadjuvant Radiotherapy for Breast Cancer

Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Breast Cancer: A Phase II Exploratory Randomized Controlled Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Neoadjuvant Radiotherapy
• Intervention / Treatment: Radiation: Neoadjuvant radiotherapy; Radiation: adjuvant radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Huojun Zhang, M.D.; Phone Number: +8613311732399; Email: chyyzhj@163.com
      • Principal Investigator: Huojun Zhang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant radiotherapy; The patient received synchronous radiotherapy and chemotherapy before surgery. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.	Radiation: Neoadjuvant radiotherapy; 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.
Active Comparator: Adjuvant radiotherapy; The patient underwent postoperative adjuvant radiotherapy. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.	Radiation: adjuvant radiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	pathological complete remission	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RCB	residual cancer burden	up to 3 weeks

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; neoadjuvant radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CHFL-BC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No