Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC

NCT06165900 | Recruiting Phase 2

• 1 other identifier: MUKDEN 08
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.

Conditions

Stereotactic Radiotherapy; Immunotherapy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• tpCR

  total pathologic complete response

  6 months

Study Arms (2)

adebrelimab plus stereotactic radiotherapy and chemotherapy

EXPERIMENTAL

Drug: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

adebrelimab plus nab-paclitaxel + carboplatin

ACTIVE COMPARATOR

Drug: adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

Interventions

adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) DRUG

Adebrelimab plus radiotherapy phase: radiotherapy was started on the day of the second cycle of adebrelimab administration every other day for 3 fractions; Adebrelimab plus chemotherapy phase: starting within 3-5 weeks after completion of radiotherapy, every 3 weeks for 6 cycles.

adebrelimab plus stereotactic radiotherapy and chemotherapy

adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) DRUG

adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

adebrelimab plus nab-paclitaxel + carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
• Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC \< 1%, PR negative: IHC \< 1%, HER2 negative: IHC 0/1 + or IHC2 + but ISH negative;
• Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
• ECOG score 0-1;
• Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
• Appropriate level of organ function
• Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.

You may not qualify if:

• Patients with metastatic breast cancer or bilateral breast cancer;
• Patients with inflammatory breast cancer or occult breast cancer;
• Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization;
• Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
• Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.
• Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test)
• Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110022, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals

Central Study Contacts

Caigang Liu, Dr.

CONTACT

18940254967; liucg@sj-hospital.org

Nan Niu, Dr.

CONTACT

18940256668; niunannancy@163.com

Study Design

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

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: December 12, 2023
• Study Start: September 26, 2023
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 15, 2028
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)