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A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC
Sponsor: Fudan University
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
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.
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.
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