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RECRUITING
NCT04215003
PHASE1/PHASE2

A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.

Official title: This is a Phase Ib/II, Prospective , Open-label, Single Center, Bayesian Adaptive Design, Umbrella Study Evaluating the Efficacy and Safety of Neo-adjuvant Therapy in Patients With Breast Cancer.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2020-01-20

Completion Date

2024-12-31

Last Updated

2024-06-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

A

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles. Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles.

DRUG

B

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.

DRUG

CL4

SHR6390(CDK4/6 inhibitor)125 mg qd(three week on one week off); oral letrozole 2.5 mg daily; Adebrelimab was given intravenously, 600mg each time, once every 2 weeks; Premenopause:Goserelin 3.6mg IM IM Q4W.

Locations (2)

Shao Zhimin

Shanghai, Please Select, China

Fudan University Shanghai Cancer Center

Shanghai, China