An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

July 28, 2020

Primary Completion Date

May 31, 2023

Study Completion Date

December 31, 2024

Conditions
TNBC - Triple-Negative Breast Cancer
Interventions
DRUG

A1: Pyrotinib with nab-paclitaxel

A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

DRUG

A2: nab-paclitaxel

A2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

DRUG

B1: everolimus with nab-paclitaxel

B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

DRUG

B2: nab-paclitaxel

B2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

DRUG

C1: PD-1 with nab-paclitaxel and famitinib

C1: PD-1 antibody SHR1210 200mg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt + famitinib 20mg po qd, 4 weeks as a cycle

DRUG

C2: nab-paclitaxel

C2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

DRUG

D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine

D1: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks.

DRUG

D2: nab-paclitaxel, with maintenance of capecitabine

D2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks.

DRUG

E1: everolimus with nab-paclitaxel

E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

DRUG

E2: nab-paclitaxel

E2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Trial Locations (1)

200032

Cancer Hospital Affiliated to Fudan University, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER