First-line Nab-paclitaxel Plus Cisplatin Plus Carilizumab in mTNBC Patients

NCT04537286 | Recruiting Phase 2

• 1 other identifier: YOUNGBC-11
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  Progression free survival

  6 weeks

• Adverse events

  Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

  6 weeks

Study Arms (1)

nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)

EXPERIMENTAL

Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q2w

Drug: nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)

Interventions

nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1) DRUG

Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q2w

nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)

Eligibility Criteria

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

You may qualify if:

• Female patients aged 18-70 years who had
• Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.
• Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
• Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
• At least one measurable lesion according to RECIST 1.1,
• ECOG performance status ≤ 1
• Life expectancy of more than 12 weeks
• Adequate organ and bone marrow function.

You may not qualify if:

• Patient of childbearing potential but unwilling to receive contraception.
• Radiation therapy of axial bone within 4 weeks before enrollment.
• Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
• Patients have active autoimmune diseases.
• Patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
• Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
• Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
• Uncontrolled infection.

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

130-nm albumin-bound paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Biyun Wang, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biyun Wang, Professor

CONTACT

+8613701748410; pro_wangbiyun@163.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

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 3, 2020
• Study Start: August 25, 2020
• Primary Completion: September 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)