Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Vinorelbine

Paclitaxel

Apatinib

Albumin-Bound Paclitaxel

Fluzoparib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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).

Capecitabine tablets

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).

Eribulin mesylate injection

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

Symptoms and General Pathology

Neoplasm Metastasis

Neoplasm, Residual

Neoplastic Processes

Capecitabine, Oral, 500 Mg

Zhiyong Yu, PhD

Leilei Wang, MD

This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.

Capecitabine Versus Vinorelbine in High Risk Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy

Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID

To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Capecitabine Versus Vinorelbine in High Risk Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy	NCT03703427	Pathologic Resi...	Capecitabine, O... Vinorelbine Tar...	20 Years - 75 Years	Shandong Cancer Hospital and Institute
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

Spots Global Cancer Trial Database for vinorelbine tartrate oral