RecruitingNot ApplicableNCT06313073

Neoadjuvant Radiotherapy for Breast Cancer

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


Sponsor

Changhai Hospital

Enrollment

60 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how radiation therapy given before surgery (neoadjuvant radiotherapy) works for breast cancer patients who also need chemotherapy or targeted therapy before their operation. Researchers want to understand the best timing and approach for combining radiation with other treatments. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with invasive breast cancer confirmed by biopsy - Your breast cancer is early to locally advanced stage (T1–T3, N0–N3, no distant spread) - You need pre-surgery therapy because: your tumor is large (over 5 cm), cancer has spread to lymph nodes, your cancer is HER2-positive or triple-negative, or you want breast-conserving surgery but the tumor is too large - Your treatment plan already includes radiation after surgery **You may NOT be eligible if...** - Your BRCA gene mutation status is unknown - Your tumor type or hormone receptor status (ER, PR, HER2, Ki67) has not been confirmed by pathology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONNeoadjuvant 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.

RADIATIONadjuvant 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.


Locations(1)

Changhai hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06313073


Related Trials