Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Estradiol

Fluorouracil

Antibodies

Capecitabine

Vinorelbine

Fulvestrant

Estrogens

Antibodies, Bispecific

Immunoglobulins

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Mitogens

Vinca Alkaloids

Antimitotic Agents

Estrogen Antagonists

Estrogen Receptor Antagonists

Tubulin Modulators

Antimetabolites

Antineoplastic Agents, Hormonal

Hormones

Hormone Antagonists

TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle.

TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle

TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.

TQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle.

TQB2930 for injection is a HER2 bispecific antibody.

TQB2930 for injection

It is an anti-microtubule chemotherapy drug

Paclitaxel for injection (albumin-bound)

TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.

TQB3616 capsule

Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol

Fulvestrant injection

Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.

Capecitabine tablets

Vinorelbine is an anti-tumor drug of vinca alkaloids.

Vinorelbine tartrate injection

Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.

Eribulin mesylate injection

Gemcitabine is a cell cycle specific anti-metabolic anticancer agent

gemcitabine hydrochloride for injection

Qingyuan Zhang, Doctor

Xiaohua Zeng, Doctor

Xiaohua Zeng

This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).

A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer

The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects.

Optimal tolerated dose determined after the end of phase 1

The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit.

The maximum serum concentration after administration

From randomization to the time of death from any cause.

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

The time between the first medication and disease progression (PD) or death before PD.

The ratio of disease control cases (partial remission, complete response, stable disease) to total cases.

The time from the first evaluation of the tumor as a complete or partial response to the first evaluation as tumor progression or death.

The ratio of disease control cases (partial remission, complete response, stable disease ≥ 6 month) to total cases.

The maximum serum concentration after administration in arm 2

The maximum serum concentration after administration in arm 3 and 4.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

300mg/m2 of Paclitaxel Polymeric Micelles for Injection is intravenously administrated for ≥ 3 hours without special infusion device. The frequency of administration is once every 3 weeks (Q3W), and 3 weeks constitutes a treatment cycle.

Control Group：The Doctor chooses the treatment（TPC）：Eribulin Mesilate injection；Capecitabine Tablets；Gemcitabine Hydrochloride for Injection；Vinorelbine Tartrate Injection；Paclitaxel (albumin-bound).

Eribulin Mesilate injection：on days 1 and 8 of the 21-day cycle, 1.4 mg/m2 , intravenous administration; Capecitabine Tablets: On days 1 to 14 of the 21-day cycle, 1000-1250mg/m2，oral administration, twice a day (once in the morning and once in the evening; Total daily dose 2000-2500mg/m2); Gemcitabine Hydrochloride for Injection: On days 1, 8 and 15 of the 28-day cycle, 800-1200mg/m2, intravenous administration; Vinorelbine Tartrate Injection: Every first day of the week, 25mg/m2，intravenous administration; Paclitaxel (albumin-bound): On day 1 of the 21-day cycle, 260mg/m2，intravenous administration for more than 30 minutes. Three weeks constituted one course of treatment.

Subjects are given 300 mg/m2 of Paclitaxel Polymeric Micelles for Injection without special infusion device,intravenously administrated for ≥ 3 hours.Three weeks constituted one course of treatment.

Paclitaxel Polymeric Micelles for Injection

Subjects are given 1.4 mg/m2 of Eribulin Mesilate injection on days 1 and 8 of the 21-day cycle.

Eribulin Mesilate injection

Subjects are given 1000-1250mg/m2 of Capecitabine Tablets on days 1 to 14 of the 21-day cycle ,and twice a day (once in the morning and once in the evening; Total daily dose 2000-2500mg/m2).

Capecitabine Tablets

Subjects are given 800-1200mg/m2 of Gemcitabine Hydrochloride for Injection on days 1, 8 and 15 of the 28-day cycle.

Gemcitabine Hydrochloride for Injection

Subjects are given 25mg/m2 of Vinorelbine Tartrate Injection every first day of the week.

Vinorelbine Tartrate Injection

Subjects are given 260mg/m2 of Paclitaxel (albumin-bound) on day 1 of the 21-day cycle,intravenous administration for more than 30 minutes.

Paclitaxel (albumin-bound)

Xiaoya Wang

Yongmei Yin

Jiong Wu

Jian Zhang

This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens.

Treatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physician's Choice (TPC) group by the proportion of 1:1. Randomization is stratified according to three factors: number of lines of previous treatment for metastatic disease (2 or 3/4 lines), receptor status (triple-negative, non-triple-negative), and visceral metastasis (yes/no).

Progression-free survival (PFS) is the main efficacy indicator in this study. Treatment Group: Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.

Control Group: Physician's Choice Group, subjects are given Eribulin Mesilate injection; or capecitabine tablets; or gemcitabine hydrochloride for injection; or vinorelbine tartrate injection; or paclitaxel (albumin-bound). Three or four weeks constitutes one cycle of treatment.

If subject does not develop disease progression after 6 cycles of dosing, the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.

Superiority design is used in this study, progression-free survival (PFS) is the main efficacy indicator. Assuming α = 0.0249(unilateral, adjusted test level), power=80%, the median PFS of the treatment group is 6.0 months, the median PFS of the control group is 3.7 months, the enrollment period is 12 months, and the study period is 24 months. Using PASS (version 11.0) for calculation, a total of 152 subjects (76 in each group) are required to meet the statistical significance between the treatment group and the control group. In consideration of case expulsion, enlarged by 10%, a total of 168 subjects (84 in each group) are required.

Paclitaxel Polymeric Micelles for Injection Versus TPC on the Treatment of HER2-negative Metastatic Breast Cancer (MBC).

A Randomized, Controlled Phase Ⅲ Study of Paclitaxel Polymeric Micelles for Injection Versus Physician's Choice(TPC) in Human Epidermal Growth Factor Receptor 2-negative (HER2-) Metastatic Breast Cancer (MBC) Subjects Who Have Failed at Least Two Previous Chemotherapy Regimens.

PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first

Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow#up) were censored on the last date the participant was known to be alive.

Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)

Shanghai Yizhong Pharmaceutical Co., Ltd.

Docetaxel

Administered intravenously according to protocol.

The mono-chemotherapy drugs selected by the investigators included capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The option should be determined before randomization.

JSKN003

Administered according to protocol, as one option for investigator's choice (determined before randomization).

Gemcitabine hydrochloride for injection

Paclitaxel for injection (albumin-bound type)

Docetaxel injection

Erwei Song

Jing Sun

Hua Yang

Dong Yan

Weihong Zhao

Jiuwei Cui

Ying Liu

Shouman Wang

Ting Luo

Xianjun Tang

Lu Gan

man Li

Fan Wu

Ning Liao

Jieqiong Liu

Shusen Wang

Qingyuan Zhang

Xian Wang

Peifen Fu

Jian Huang

Hai Hu

yueyin Pan

Jiqing Hao

Fufan Li

Jianyun Nie

Yingxia Tian

Jingfen Wang

Guixiang Weng

Zhongmin Zhang

Weimin Xie

weimin Xie

Li Nong

Yanyan Xie

Wenfeng Li

De Zen

Guoqin Jiang

Jinnan Gao

Fuguo Tian

Feng Yao

Yanxia Zhao

Hanjun Yu

Jin Yang

Yuehua Wang

Zhengqiu Zhu

Hong Zong

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.

The study planned to enroll 400 subjects in a 1:1 ratio and stratified block randomization method assigned to:

* Experimental group: JSKN003 monotherapy
* Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.

The study planned to enroll 400 subjects in a 1:1 ratio and stratified block randomization method assigned to:

* Experimental group: JSKN003 monotherapy
* Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy.

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial

JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

PFS evaluated by BICR according to RECIST v1.1 criteria is defined as the time from randomization to the first recorded disease progression or death from any cause as a result of BICR evaluation according to RECIST v1.1 criteria.

OS, defined as the time from randomization to death from any cause;

BICR and investigators were judged according to RECIST v1.1 criteria ，objective response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria;

BICR and investigators were judged according to RECIST v1.1 criteria，Duration of response (DoR), defined as the time from the first recorded response (CR/PR) to the first documented disease progression (PD) or death from any cause;

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer	NCT06202261	Metastatic Brea... Recurrent Breas... Advanced Malign...	TQB2930 for inj... Paclitaxel for ... TQB3616 capsule Fulvestrant inj... Capecitabine ta... Vinorelbine tar... Eribulin mesyla... gemcitabine hyd...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Paclitaxel Polymeric Micelles for Injection Versus TPC on the Treatment of HER2-negative Metastatic Breast Cancer (MBC).	NCT06143553	Metastatic Brea...	Paclitaxel Poly... Eribulin Mesila... Capecitabine Ta... Gemcitabine Hyd... Vinorelbine Tar... Paclitaxel (alb...	18 Years -	Shanghai Yizhong Pharmaceutical Co., Ltd.
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer	NCT06202261	Metastatic Brea... Recurrent Breas... Advanced Malign...	TQB2930 for inj... Paclitaxel for ... TQB3616 capsule Fulvestrant inj... Capecitabine ta... Vinorelbine tar... Eribulin mesyla... gemcitabine hyd...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects	NCT06079983	Breast Cancer	JSKN003 Capecitabine ta... Gemcitabine hyd... Vinorelbine tar... Paclitaxel for ... Docetaxel injec... Eribulin mesyla...	18 Years -	Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Spots Global Cancer Trial Database for vinorelbine tartrate injection