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

Breast Cancer Clinical Trial

Official title:

A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537286
• Other study ID #: YOUNGBC-11
• Status: Recruiting
• Phase: Phase 2
• Start date: August 25, 2020
• Est. completion date: October 15, 2024

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: Biyun Wang, Professor
• Phone: +8613701748410
• Email: pro_wangbiyun[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Female patients aged 18-70 years who had

2. 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.

3. Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.

4. Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.

5. At least one measurable lesion according to RECIST 1.1,

6. ECOG performance status = 1

7. Life expectancy of more than 12 weeks

8. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Patient of childbearing potential but unwilling to receive contraception.

2. Radiation therapy of axial bone within 4 weeks before enrollment.

3. Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.

4. Patients have active autoimmune diseases.

5. Patients who need systemic corticosteroids (> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.

6. Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)

7. Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)

8. Uncontrolled infection.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
Nab-paclitaxel 125 mg/m2,ivgtt,d1, 8 Cisplatin 75 mg/m2,ivgtt,d1 Carilizumab 200mg, ivgtt,d1,q2w

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression free survival	6 weeks
Primary	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