Symptoms and General Pathology

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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.

Apatinib

Fluzoparib

Protein Kinase Inhibitors

Enzyme Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Fluzoparib combined with Apatinib group: Fluzoparib capsules oral +Apatinib Mesylate oral; each treatment cycle defined as 3 weeks (21 days).

Control group: Control group: patients receive oral Capecitabine tablets, Vinorelbine Tartrate Capsules, or use intravenous Paclitaxel for Injection (Albumin Bound), Gemcitabine Hydrochloride for Injection, or other drugs selected by the investigator.

Fluzoparib capsules appropriate dose oral, each treatment cycle defined as 3 weeks (21 days).

Apatinib Mesylate oral; each treatment cycle defined as 3 weeks (21 days).

Apatinib Mesylate

Capecitabine tablets, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

For the first three courses: reasonable dosage with reference to guidelines. After 3 courses of medication, it is recommended to increase the dose of vinorelbine tartrate once a week. Each treatment cycle defined as 3 weeks (21 days).

Vinorelbine Tartrate Oral

Eribulin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

Gemcitabine, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

Gemcitabine Hydrochloride

Paclitaxel-albumin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

Paclitaxel-albumin

Zhao Jianli

Jianli Zhao

This study develops a new therapeutic approach for HER2-negative advanced breast cancer patients without precise treatment targets. The trial aims at extending the combination target therapy involving PARP inhibitors and anti-angiogenesis from only BRCA mutation carriers to all patients with homologous recombination repair defects (HRD-positive). The phase III randomized clinical study will investigate the effectiveness of the combination therapy of PARP inhibitor "fludzoparib" and anti-angiogenic "apatinib" in treating HRD-positive/HER2-negative advanced breast cancers.

Breast cancer is the most prevalent malignant tumor in the world, and 30% of breast cancer patients will enter the advanced stage due to treatment failure. 80% of these patients have HER2-negative subtype breast cancer, which has not yet been found the similar target as HER2, with the median survival time of only 6-20 months. In the past, ovarian cancer patients faced the dilemma of poor survival due to the lack of precise targeted therapy. However, through a series of clinical studies, experts in the field of ovarian cancer have successfully expanded the indications of PARP inhibitor-based combination targeted therapy from the small population of BRCA mutation(20%) to the large population of HRD-positive (Homologous recombination deficiency) (50%), which has significantly prolonged the survival time of patients. Because causes other than BRCA mutations can also cause tumor cells to be "HRD" and thus sensitive to PARP inhibitors, so that HRD-positive patients are likely to benefit. The HRD-positive profile of nearly 50% of the patients could be a potential beneficiary of PARP inhibitor-based targeted therapy. The synergistic effect of PARP inhibitor and anti-angiogenic combination therapy has already been confirmed in preliminary cellular experiments and clinical studies related to ovarian cancer. Further cell-based experiments and preclinical studies have also confirmed the feasibility of the combination targeted therapy in the HRD-positive/HER2-negative subtype of breast cancer. Therefore, we intend to further validate the efficacy and safety of the PARP inhibitor fluazoparib in combination with the antiangiogenic abatinib in a Phase III, randomized, controlled clinical study, in order to provide HRD-positive/HER2-negative breast cancer patients with a better choice of precision targeted therapy.

Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer

As personal information of patients is involved, we decided not to share individual participant data of patients.

The time from the beginning of treatment to the progression or death of the patient

the proportion of patients with a tumor volume reduction of ≥30% and a minimum timeframe according to accepted response evaluation criteria (e.g., RECIST version 1.1 in solid tumors), including cases of complete response (CR) and partial response (PR).

Proportion of confirmed complete response, partial response, or stable disease ≥ 24 weeks.

Proportion of patients with stable or shrinking tumor size，sum of the proportions of complete remission (CR), partial remission (PR) and stable disease (SD)

The time from the start of randomization to death due to any cause.

The probability and severity of adverse reactions, and the extent and incidence of AEs were assessed according to CTCAE.

The function or quality of a patient's physical, psychological, and social adaptability is also known as quality, which is assessed according to the EROTC C30 scale.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

Jiong Wu

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

Yongmei Yin

Weimin Xie

weimin Xie

Li Nong

Yanyan Xie

Wenfeng Li

Jian Zhang

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.
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer	NCT06255392	Breast Cancer	Fluzoparib Apatinib Mesyla... Capecitabine ta... Vinorelbine Tar... Eribulin mesyla... Gemcitabine Hyd... Paclitaxel-albu...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer	NCT06255392	Breast Cancer	Fluzoparib Apatinib Mesyla... Capecitabine ta... Vinorelbine Tar... Eribulin mesyla... Gemcitabine Hyd... Paclitaxel-albu...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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

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