Neoadjuvant Radiation in Locally Advanced Breast Cancer

NCT05479409 | Unknown Phase 2

• 1 other identifier: FDRT-BC016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

breast cancer; neoadjuvant radiotherapy; biomarkers

Outcome Measures

Primary Outcomes (3)

• Pathological response rate

  only for operable patients

  1 year

• Fbjective response rate(ORR)

  for inoperable patients

  3 year

• Event free survival(EFS)

  for all patients

  3 year

Secondary Outcomes (2)

• Time to progression

  3 year

• Radiation Toxicity

  6 months

Other Outcomes (2)

• Biologic predictor for treatment response

  before treatment

• The role of ultrasound in predicting treatment response

  before and 1 month after treatment

Study Arms (1)

Neoadjuvant radiotherapy

EXPERIMENTAL

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.

Radiation: Neoadjuvant radiotherapy

Interventions

Neoadjuvant radiotherapy RADIATION

radiation therapy combined with chemotherapy prior to surgery

Neoadjuvant radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Xiaoli Yu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Yu

CONTACT

+86-021-64175590; stephanieyxl@hotmail.com

Jin Meng

CONTACT

+86 18121299532; jademj@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Preoperative radiotherapy and concurrent chemotherapy

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 29, 2022
• Study Start: March 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)