MedDataX Logo

Neoadjuvant Radiation in Locally Advanced Breast Cancer

NCT ID: NCT05479409

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

OUTLINEļ¼š 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

breast cancer neoadjuvant radiotherapy biomarkers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Preoperative radiotherapy and concurrent chemotherapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neoadjuvant radiotherapy

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.

Group Type EXPERIMENTAL

Neoadjuvant radiotherapy

Intervention Type RADIATION

radiation therapy combined with chemotherapy prior to surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neoadjuvant radiotherapy

radiation therapy combined with chemotherapy prior to surgery

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiaoli Yu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiaoli Yu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaoli Yu

Role: CONTACT

Phone: +86-021-64175590

Email: [email protected]

Jin Meng

Role: CONTACT

Phone: +86 18121299532

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaoli Yu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FDRT-BC016

Identifier Type: -

Identifier Source: org_study_id