Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Capecitabine

Letrozole

Albumin-Bound Paclitaxel

Goserelin

Pertuzumab

Androgen Receptor Antagonists

6 cycles of Paclitaxel,Carboplatin, Herceptin and Pertuzumab treatment with a good clinical benefit response depending on HR/HER-2 status.

2 cycles of Paclitaxel,Carboplatin, Herceptin treatment with a good clinical benefit response depending on HR/HER-2 status following surgery

If patients were HR+ and HER2- without PI3K-AKT pathway mutation

If patients were HR+ and HER2- with PI3K-AKT pathway mutation

If patients were HR+ and HER2+ without PI3K-AKT pathway mutation

If patients were HR+ and HER2+ with PI3K-AKT pathway mutation

If patients were HR- and HER2+ without PI3K-AKT pathway mutation

If patients were HR- and HER2+ with PI3K-AKT pathway mutation

If patients were HR- and HER2- with LAR subtype

HR+ and HER2-; No correlated pathway variation

TNBC with Homologous Recombination Repair Defect (HRD)

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.

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:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off) oral letrozole 2.5 mg daily； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); Alpelisib 300mg PO QD； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off) oral letrozole 2.5 mg daily； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

CLH1

Drug:

oral letrozole 2.5 mg daily; Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

CLH2

Drug:

pyrotinib(EGFR-TKI) 400mg qd； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； capecitabine 1000mg/m2 bid(d1-d14)

Drug:

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； Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg po.qd(three week on one week off) SHR3680（AR inhibitor）240 mg po. qd.

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.

Famitinib 20mg orally once daily; Albumin paclitaxel 100mg/ m2, i.v.; Combined carboplatin AUC=2, i.v.; d1, 8, 15,21 days a cycle, a total of 4 cycles.

Fluzoparil 150mg orally twice daily; Famitinib 20mg orally once daily;

Adebrelimab was administered intravenously, 600mg each time, once every 2 weeks; Famitinib 20mg once daily; Albumin paclitaxel 100mg/m2 qw intravenous drip (used for 3 weeks/stopped for 1 week), 28 days per treatment cycle;

Zhimin Shao, MD.PhD.

Zhimin Shao, PhD

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.

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

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.

pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.

ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC	NCT04215003	Breast Cancer	A B CL1 CL2 CLH1 CLH2 CH1 CH2 CT1 CL4 CL3 CT2 CT3 CT4	18 Years - 70 Years	Fudan University
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC	NCT04215003	Breast Cancer	A B CL1 CL2 CLH1 CLH2 CH1 CH2 CT1 CL4 CL3 CT2 CT3 CT4	18 Years - 70 Years	Fudan University

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