Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Paclitaxel

Fulvestrant

Albumin-Bound Paclitaxel

Fluzoparib

Maleic acid

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Enzyme Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

JS105 administered orally, Fulvestrant intramuscularly

JS105 administered orally, Dalpiciclib administered orally, Fulvestrant intramuscularly

JS105 administered orally, Toripalimab intravenous infusion

JS105 administered orally, Paclitaxel (Albumin Bound) intravenous infusion

JS105 administered orally, Fluzoparib administered orally

JS105 administered orally, Pyrotinib administered orally,Capecitabine administered orally

JS105 administered orally, Toripalimab intravenous infusion, Paclitaxel (Albumin Bound) intravenous infusion

JS105

Fulvestrant intramuscularly,The first cycle was injected once in D1 and D15, and then once in each cycle D1, and 28 days was 1 cycle

Fulvestrant injection

Dalpiciclib Isetionate Tablets, QD, oral, taken continuously for 21 days, then stopped for 7 days, 28 days for a cycle

Dalpiciclib Isetionate Tablets

Toripalimab Injection,Intravenous infusion, once every 3 weeks, 21 days for 1 cycle

Toripalimab Injection

Paclitaxel for Injection (Albumin Bound),Intravenous infusion, D1, 8, 15 infusion, every 28 days for a cycle

Paclitaxel for Injection (Albumin Bound)

Fluzoparib Capsules is administered once daily, orally

Fluzoparib Capsules

Pyrotinib Maleate Tablets is administered once daily, orally

Pyrotinib Maleate Tablets

Capecitabine Tablets is administered once daily, orally

Capecitabine Tablets

Jing Ding

Min Yan

This study is an open-label, multicenter, Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS105 in combination with other anti-tumor therapies in patients with advanced solid tumors. Patients will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage.

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

The proportion of patients with PIK3CA mutations in tumor remission

Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

Objective Response Rate (ORR) as Assessed by Investigator according to RECIST v1.1

Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1

Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1

Area under the curve of JS105,dalpiciclib and fluzoparib

Time to reach maximum concentration of JS105,dalpiciclib and fluzoparib

Maximum Plasma Concentration (Cmax) of JS105, dalpiciclib and fluzoparib

Apparent volume of distribution of JS105, dalpiciclib and fluzoparib

Clearance(CL) of JS105, dalpiciclib and fluzoparib

Half-life(T1/2) of JS105, dalpiciclib and fluzoparib

Risen (Suzhou) Pharma Tech Co., Ltd.

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Trastuzumab

Cyclophosphamide

Epirubicin

Progesterone

Antineoplastic Agents, Immunological

Preoperative

-Drug: Pyrotinib Maleate Tablets combined with Albumin Paclitaxel and Trastuzumab.

Surgery:Subjects should be evaluated by tumor-enhanced MRI combined with mammary gland ultrasound during the preoperative neoadjuvant administration, and evaluated every 2 cycles. The subjects who were evaluated for CR and PR for the first time should be confirmed after at least 4 weeks. The confirmed tumor assessment cannot change the previously fixed examination time point.

Postoperative

* Drug: Epirubicin hydrochloride combined with Cyclophosphamide
* At the same time, according to the recommendation of the clinician, choose whether to accept the same anti-HER2 treatment plan before surgery. For patients with tumors positive for estrogen receptor (ER) and/or progesterone receptor (PR), endocrine therapy should be given at the end of adjuvant chemotherapy, and if there is clinical indication at the end of adjuvant chemotherapy, radiotherapy should be given.

Albumin Paclitaxel

The first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles.

Ting Luo, MD

This study was designed to evaluate the efficacy and safety of pyrotinib combined with albumin paclitaxel and trastuzumab in the treatment of Her2-positive early or locally advanced breast cancer, and to explore RCB scores and TILs expression and other related molecular markers for pyrrole the efficacy of the treatment with pyrotinib.

At present, the treatment mode of breast cancer has gradually turned to the individualized comprehensive treatment mode combining systemic therapy and local therapy, and neoadjuvant therapy is widely used. Albumin-bound paclitaxel alters the excipients, reduces adverse reactions and greatly enhances efficacy, facilitating clinical applications. Studies have shown that in the use of neoadjuvant chemotherapy, drugs containing purple shirts and anthracyclines will be the drug of choice. The HER2/erbB2 molecule is an independent prognostic factor for breast cancer. About 20%-30% of adenocarcinoma patients have amplification/overexpression of HER2 gene. These patients are insensitive to conventional therapy and are more prone to recurrence and metastasis. Shorter survival and poorer prognosis. Current drugs targeting HER2 targets mainly include macromolecular monoclonal antibodies and their conjugates and small molecule tyrosine kinase inhibitors. Pyrotinib is an irreversible inhibitor of small targets (EGFR and HER2). Compared with trastuzumab, it has different sites of action, which may lead to synergy in the treatment of human Her2-positive breast cancer.

The excellent clinical efficacy of dual-targeted neoadjuvant therapy for Her2 positive breast cancer, the anti-tumor effect and good tolerance of pyrotinib, we intend to develop a pyrotinib combined with albumin paclitaxel and trastuzumab one-arm exploratory clinical study of neoadjuvant therapy for Her2-positive early or locally advanced breast cancer with the aim of assessing efficacy and safety, and exploring the efficacy of tumor-associated molecular markers such as RCB scores and TILs expression for pyrotinib treatment predicting effectiveness.

Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer

A Single-arm, Exploratory Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Early or Locally Advanced Breast Cancer and Its Biomarkers

Invasive tumor residuals in the breast and axillary lymph nodes without microscopic examination, ductal carcinoma in situ may exist.

The proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator.

The proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST1.1 by the investigator.

The RCB category (RCB-0, RCB-I, RCB-II, or RCB-III) was defined according to the M.D. Anderson Cancer Center standard, and the RCB score was associated with the patient's prognosis.

This outcome measure is designed to measure the amount of TILs in newly diagnosed luminal A and Triple Negative Breast Cancer (TNBC) tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after IORT between the two different breast cancer sub types.

Jiangsu HengRui Medicine Co., Ltd.

West China Hospital

Assisting staff

Docetaxel

Pertuzumab

Epirubicin 100 mg/m2, iv cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po 4-week treatment, sequential docetaxel 80 mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + patuximab 420 mg (first dose 840 mg), iv ,po 4 weeks of treatment

Addition of Pyrotinib in the EC phase to the standard treatment EC-THP regimen recommended by the guidelines.

Hou jinxuan

This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.

Recruiting patients with clinical stage II to III HER2-positive breast cancer for primary treatment, eligible subjects will be enrolled as follows： This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant regimen of Pyrotinib in combination with trastuzumab + pertuzumab.Eligible subjects who met the enrollment criteria and signed the informed consent form entered the trial period and received epirubicin 100 mg/m2, iv cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po for 4 weeks, sequential docetaxel 80 mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + pertuzumab 420 mg (first dose 840 mg), iv ,po 4 cycles of treatment. Surgery was performed at the end of the above treatment cycles, and adjuvant targeted therapy was continued after surgery: trastuzumab + patuximab for 1 year.

Eligible subjects (20) who met the nadir criteria and signed the informed consent form entered the trial period and received the ECPy-THP regimen: i.e., epirubicin 100 mg/m2, iv + cyclophosphamide 600 mg/m2, iv + Pyrotinib 400 mg/d, po 4 cycles, sequential docetaxel 80 mg/m2, iv + trastuzumab 6 mg/kg (first dose 8 mg/kg), iv + patuximab 420 mg (first dose 840 mg), iv, po 4 cycles of treatment. If the efficacy of 4 cycles was evaluated as PD or SD, the regimen was promptly adjusted for surgical treatment.

Surgery was performed at the end of the above treatment cycles, and adjuvant targeted therapy was continued after surgery: patients who reached pCR continued trastuzumab + pertuzumab for 1 year, and non-pCR patients were treated according to the guideline-recommended backline regimen.

All patients underwent surgery or radiotherapy continuation within 16-20 d after completion of the neoadjuvant chemotherapy cycle, and the efficacy was assessed 1 to 2 d before continuation of treatment.

Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP

Exploratory Study of Triple-targeted Neoadjuvant Treatment of HER2-positive Breast Cancer With Pyrotinib in Combination With Trastuzumab and Pertuzumab

Wuhan University

Director

Carcinoma

Pan Yueyin

To evaluate the efficacy and safety of Pyrotinib Maleate Tablets in the treatment of advanced breast cancer patients with positive her-2.

This study intends to carry out multicenter, observational cohort clinical research, using maleic acid pyrrole for his piece of HER-2 positive treatment of advanced breast cancer treatment, observation and verification maleic acid pyrrole for his piece for a line or a single drug resistance by bead in the real diagnosis and treatment in patients with advanced breast cancer environment and the efficacy and safety of new treatments. Biomarkers of breast cancer prognosis are of great significance in predicting the degree of malignancy, metastasis and recurrence of breast cancer, as well as guiding clinical treatment programs.This study will explore the prognostic factors and curative effect of breast cancer patients from multiple aspects, explore the dominant population of breast cancer patients with pyrrolidone maleate, and provide the theoretical basis for individualized treatment for clinical treatment practice.

A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2

Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual

overall survival is defined as the length of time from random assignment to death or to last contact.

adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments

Disease control rate (DCR) refers to the percentage of cases with remission and disease stability after treatment in the total number of evaluable cases

Disease-free survival (DFS) is defined as the time from the beginning of randomization to recurrence or death due to Disease progression

Disease /recurrence free survival (DDFS) refers to a period of time after treatment for a tumor patient where no metastatic lesions were found anywhere else in the body except for the accident of the primary lesion

Anhui Provincial Hospital

Rare Diseases

Myotonic Dystrophy Type 1

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Ado-Trastuzumab Emtansine

Adenosine

Maytansine

Immunotoxins

Immunoconjugates

Immunologic Factors

Trastuzumab Emtansine for Injection: 3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle; Pyrotinib Maleate Tablets: The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle; Efficacy was assessed every two cycles and treatment was continued until disease progression or intolerable toxicity or death.

3.6 mg/kg body weight (IV), administered on day 1, 21 days as a treatment cycle;

Trastuzumab Emtansine for Injection

The initial dose is 320 mg (PO), administered orally within 30 minutes after meals, at the same time every day, 21 days as a treatment cycle;

Chunfang Hao, PhD

This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.

Female patients with advanced breast cancer aged ≥18 years and ≤75 years old

Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

A Prospective, Multicenter，Phase II Clinical Study of Trastuzumab and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors	NCT06208410	Advanced Solid ...	JS105 Fulvestrant inj... Dalpiciclib Ise... Toripalimab Inj... Paclitaxel for ... Fluzoparib Caps... Pyrotinib Malea... Capecitabine Ta...	18 Years - 75 Years	Risen (Suzhou) Pharma Tech Co., Ltd.
Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer	NCT04152057	Breast Cancer HER2 Positive Combination Che...	Pyrotinib Malea... Albumin Paclita... Trastuzumab	18 Years - 70 Years	West China Hospital
Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP	NCT04929548	Breast Cancer	Pyrotinib Malea...	18 Years - 70 Years	Wuhan University
Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP	NCT04929548	Breast Cancer	Pyrotinib Malea...	18 Years - 70 Years	Wuhan University
A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2	NCT03908749	HER2 Positive B...		18 Years -	Anhui Provincial Hospital
A Real-world Clinical Study of Pyrotinib Maleate Tablets in the Treatment of Breast Cancer Patients With Positive Her-2	NCT03908749	HER2 Positive B...		18 Years -	Anhui Provincial Hospital
Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer	NCT04152057	Breast Cancer HER2 Positive Combination Che...	Pyrotinib Malea... Albumin Paclita... Trastuzumab	18 Years - 70 Years	West China Hospital
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors	NCT06208410	Advanced Solid ...	JS105 Fulvestrant inj... Dalpiciclib Ise... Toripalimab Inj... Paclitaxel for ... Fluzoparib Caps... Pyrotinib Malea... Capecitabine Ta...	18 Years - 75 Years	Risen (Suzhou) Pharma Tech Co., Ltd.
Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy	NCT05560308	HER2+ Advanced ...	Trastuzumab Emt... Pyrotinib Malea...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital

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