Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Utidelone (30 mg/m2, days 1-5, every 3 weeks)

Utidelone

Tirelizumab（200mg, day1, every 3 weeks）

Tirelizumab

Bevacizumab(7.5mg/kg, day1, every 3 weeks)

Huihua Xiong, PI

Tengfei Chao, Sub-I

This is a multicenter, open-label, single-arm clinical study designed to evaluate the safety and efficacy of Utidelone plus Tirelizumab and Bevacizumab for advanced or metastatic triple-negative breast cancer (TNBC).

The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospective, Open Clinical Study

The proportion of patients with complete response or partial response, using RECIST v1.1.

Time from initial treatment to the first documented disease progression or death due to any cause, whichever occurs first

The proportion of patients with complete response, partial response or stable disease,using RECIST v 1.1.

The time from enrollment to death from any cause

The incidence and severity of Adverse Events (AEs)

Huihua Xiong

Professor

Antirheumatic Agents

Gemcitabine

Capecitabine

Trastuzumab

Vinorelbine

Paclitaxel

Cyclophosphamide

Carboplatin

Doxorubicin

Liposomal doxorubicin

Sacituzumab govitecan

Trastuzumab deruxtecan

Fluorouracil

Albumin-Bound Paclitaxel

Taxane

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Immunoconjugates

Immunologic Factors

Subjects randomized to the organoid-guided treatment (OGT) group will be treated with the drugs predicted to be the most sensitive through PDO drug sensitivity screening. Drugs that the subjects have progressed on before randomization will not be screened. The drugs selected for organoid screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).

Subjects randomized to the treatment of physician's choice (TPC) group will receive physician-chosen therapy from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).

The drugs predicted to be the most sensitive through organoid drug sensitivity screening. The drugs selected for sensitivity screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).

Organoid-guided treatment

Albumin-bound paclitaxel 260mg/m2, IV, q3w, or 100-125mg/m2, IV, days 1, 8, and 15, q4w OR Liposomal paclitaxel 175mg/m2, IV, q3w

Eribulin

Liposomal doxorubicin 50mg/m2, IV, q3w OR Liposomal doxorubicin 40mg/m2+Cyclophosphamide 600mg/m2, IV, q3w

Anthracycline

Carboplatin AUC 6, IV, q3w or q4w OR Carboplatin AUC 2+Gemcitabine 1000mg/m2, IV, days 1 and 8, q3w OR Carboplatin AUC 2+Albumin-bound paclitaxel 125mg/m2, IV, days 1 and 8, q3w

30mg/m2, IV, once per day on days 1-5, q3w

Kun Wang, M.D.

Hong-Fei Gao, M.D.

This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.

Treatment for advanced-stage breast cancer has long been challenging. Genomic-based precision medicine was able to facilitate treatment selection in some patients, but there were considerable instances where genomic profiling failed to assign effective interventions or patients exhibited refractoriness to the drugs nominated by genomic alterations. Patient-derived organoids (PDOs) represent a tractable tool that may compensate for the drawbacks of genomic medicine to identify therapeutic opportunities in rare or metastatic cancers. Previous research has demonstrated that PDOs displayed strong biological fidelity to their original tumors and functional precision medicine based on PDO drug screening could confer survival benefits in breast cancer patients.

This multicenter, open-label, randomized phase II trial aims to investigate the safety and efficacy of organoid-guided treatment (OGT) versus treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. Randomization will be stratified by hormone receptor status and prior chemotherapy for the advanced or metastatic disease. Subjects in the OGT group will receive treatment predicted to be the most efficacious by the PDO drug sensitivity screening, and subjects in the TPC group will receive treatment selected by the treating physician. Treatments tested in PDO drug screening or chosen by the treating physician will be guided by NCCN guidelines. Treatment that subjects have previously received before randomization is no longer subjected to PDO sensitivity screening. This study will provide valuable evidence on the real-time application of PDOs in the context of clinical care.

Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial

PFS is defined as the time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression according to RECIST version 1.1 or death due to any cause. Subjects who are alive with no objective documentation of (radiographic) disease progression by the data cutoff date for PFS analysis will be censored at the date of their last evaluable tumor assessment. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

OS is defined as the time from the date of randomization to the date of death for any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.

ORR is defined as the sum of complete response (CR) rate and partial response (PR) rate according to RECIST version 1.1. CR is defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR is defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

DCR is defined as the sum of CR rate, PR rate, and stable disease (SD) rate. SD is defined as neither sufficient shrinkage to qualify for PR (taking as reference the sum of diameters at baseline) nor sufficient increase to qualify for PD (taking as reference the smallest sum of diameters while on study).

CBR is defined as the sum of CR rate, PR rate, and more than 6 months' SD rate.

DoR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression, or death. DoR will be measured for responding subjects (PR or CR) only. Subjects who are progression-free at the time of the analyses will be censored at the date of the last evaluable tumor assessment.

TTR is defined as the time from the date of randomization to the date of the first documentation of objective response (CR or PR). TTR will be measured for responding subjects (CR or PR) only.

Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

First Affiliated Hospital, Sun Yat-Sen University

Sun Yat-sen University

Shantou Central Hospital

Guangdong Provincial People's Hospital

M.D.

Symptoms and General Pathology

Recurrence

8 patients will be assigned to utidelone plus capecitabine arm receiving utidelone plus capecitabine. Utidelone injection 30mg/m2/day, intravenously administered once a day for 5 consecutive days; capecitabine tablets, 1000mg/m2, orally, 2 times a day for 14 consecutive days. 21 days is a cycle

Utidelone Injection; capecitabine

8 patients will be assigned to utidelone arm and receive utidelone injection 30 mg/m2/day intravenously, once a day for 5 consecutive days in a 21-day cycle.

Quchang Ouyang, MD

This trial is an open, multi-center, phase Ic clinical study on the pharmacokinetics and drug interactions of utidelone injection combined with capecitabine in patients with recurrent and metastatic breast cancer.

The purpose of this trial is:

1. To evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone.
2. To evaluate the drug interaction of utidelone and capecitabine.

PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer

Open, Multicenter, Phase Ic Clinical Study on the Pharmacokinetics and Drug Interactions of Utidelone Plus Capecitabine in Patients With Recurrent and Metastatic Breast Cancer

To measure the maximal plasma concentration of the study drugs and evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone, measure PK parameters such as Maximum Plasma Concentration \[Cmax\]

To evaluate the pharmacokinetic interaction of utidelone and capecitabine in patients when administered in combination.

To get area under the plasma concentration versus time curve

Chengdu Biostar Pharmaceuticals

Beijing Biostar Pharmaceuticals Co., Ltd.

Docetaxel

Eligible patients will receive treatment with utidelone(40 mg/ m2 /day, D1-5,Q3W) , treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.

utidelone

Eligible patients will receive treatment with docetaxel (75mg/ m2/day, D1, Q3W) , treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.

docetaxel

shusen wang, MD

Quchang OuYang, MD

It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.

Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer

Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial

Time from randomization to progression or death (whichever occurred first)

The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria

the time from randomization to the first documentation of disease response (CR or PR)

the time from the first evaluation that criteria for CR or PR are met until PD or death is observed, whichever occurs first, calculated only for patients whose best response is evaluated as CR or PR.

Time from randomization to death Time from randomization to death Time from randomization to death Time from randomization to death

Change from baseline in the FACT-B total score for all questionnaire timepoints. To calculate FACT-B total score patient ratings from 0 (not at all) - 4 (very much) to each of the 37 questionnaire statement are summed up. Total score range: 0 - 148. Higher values indicate better quality of life.

Hunan Cancer Hospital

Chief Physician

Anti-Infective Agents

Hormones

Epirubicin

Mitogens

Pertuzumab

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Hormone Receptor(HR) negative, Human Epidermal Growth Factor Receptor 2(HER2 )negative breast cancer Drug: Utidelone in combination with carboplatin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin ,Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total.

HR positive, HER2 negative, Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH)non-amplification breast cancer Drug: Utidelone in combination with Epirubicin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Epirubicin 75mg/m2 was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total.

Drug: Utidelone in combination with carboplatin, trastuzumab and pertuzumab Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. Trastuzumab 8mg/kg iv in first cycle on day 1, then 8mg/kg in the rest cycles; pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles.

One treatment cycle is 21 days, and there are 6 cycles in total.

Utidelone injection 30mg/m2, on days 1-5 of each cycle

Carboplatin Area under curve(AUC)6, iv, was administered on day 1

Epirubicin 75mg/m2 was administered on day 1

Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles

Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles

The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone based regimen as neoadjuvant treatment With High-risk Early-stage or Locally Advanced Breast Cancer.

This is a single arm, multi-center study,three-cohort, prospective phase II study which will enroll 181 high-risk early-stage or locally advanced breast cancer patients.

Study of Utidelone based neoadjuvant treatment on early high-risk or locally advanced breast cancer

Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer

Percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and breast

Percentage of patients whose pathological evaluation of hematoxylin and eosin-stained breast samples do not show any residual invasive carcinoma

Time from the first dose of study intervention administration to any of the following events: progression of disease that precludes surgery, local or distant recurrence after surgery, second primary malignancy (breast or other invasive cancers), or death due to any cause.

Graded according to the Common Terminology Criteria for Adverse Event (CTCAE) grade and changes in CTCAE grade

National Cancer Center of China-Breast Cancer-A 1.0 (NCC-BC-A 1.0) during the study was used to assess the quality of life；The minimum to maximum values: 0 , 100 Meaning: the higher scores mean a better outcome.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-chemotherapy-induced peripheral neuropathy(CIPN) twenty-item scale (QLQ-CIPN20) was used to assess the quality of life.

Chinese Academy of Medical Sciences Cancer Hospital，Shanxi Center

Chinese Academy of Medical Sciences Cancer Hospital，Shenzhen Center

First Affiliated Hospital of China Medical University

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Deputy Director of the Department of Medical Oncology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

HER2-negative advanced breast cancer with brain metastases who have received at least one prior anthracycline and one prior taxane

HER2-positive advanced breast cancer with brain metastases who have failed trastuzumab and pyrotinib

30mg/m2 (±10%), day 1-5 every 3-week cycle

Min Yan

Huimin Lv

Min Yan, Professor

This study aims to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases, and thus provides a new systemic treatment strategy for those patients.

This is a multicenter,open label, phase 2 trial to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases. Patients with HER2-negative advanced breast cancer who have received at least one prior anthracycline and one prior taxane or HER2-positive advanced breast cancer who have failed trastuzumab and pyrotinib, and with at least one measurable CNS lesion are eligible for the study.

This study includes 2 cohorts, and the Simon two-stage design are applied, respectively. A total of 48 patients with HER2-negative advanced breast cancer are included in cohort 1, and 52 patients with HER-2 positive patients are enrolled in cohort 2. Patients in both cohorts receive bevacizumab, 15mg/kg, day 1, and utidelone, 30mg/m2 (±10%), day 1-5 every 3-week cycle until disease progression or unmanageable toxicity. The primary endpoint is CNS-ORR according to the RECIST 1.1. The secondary endpoints include CNS-ORR according to RANO criteria, CNS-PFS assessed by investigator, extracranial ORR, extracranial PFS, OS, time to WBRT, quality of life and safety profile according to NCI-CTCAE 5.0.

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases: A Multicenter, Single Arm, Open Label, Phase II Trial

Individual participant data that underlie the results reported in this article, after de-identification are available following article publication.

the proportion of patients with the best intracranial response of confirmed complete or partial response according to RECIST 1·1, as assessed by the investigator

the proportion of patients with the best intracranial response of confirmed complete or partial response according to RANO criteria, as assessed by the investigator

time from the first dose to disease progression or any-cause death

proportion of patients with confirmed extracranial complete or partial response per RECIST 1·1

time from the first dose of study drug to any-cause death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospective, Open Clinical Study	NCT06125080	TNBC - Triple-N...	Utidelone Tirelizumab Bevacizumab	18 Years - 70 Years	Tongji Hospital
The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ：Single-arm, Prospective, Open Clinical Study	NCT06125080	TNBC - Triple-N...	Utidelone Tirelizumab Bevacizumab	18 Years - 70 Years	Tongji Hospital
Organoid-based Functional Precision Therapy for Advanced Breast Cancer	NCT06102824	HER2-negative B... Advanced Breast...	Organoid-guided... Taxane Capecitabine Gemcitabine Vinorelbine Eribulin Anthracycline Carboplatin Utidelone Trastuzumab der... Sacituzumab gov...	18 Years - 80 Years	Guangdong Provincial People's Hospital
PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer	NCT05052437	Advanced and Me...	Utidelone Injec... Utidelone	18 Years - 75 Years	Beijing Biostar Pharmaceuticals Co., Ltd.
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer	NCT05430399	Breast Neoplasm... Locally Advance...	utidelone docetaxel	18 Years -	Sun Yat-sen University
Organoid-based Functional Precision Therapy for Advanced Breast Cancer	NCT06102824	HER2-negative B... Advanced Breast...	Organoid-guided... Taxane Capecitabine Gemcitabine Vinorelbine Eribulin Anthracycline Carboplatin Utidelone Trastuzumab der... Sacituzumab gov...	18 Years - 80 Years	Guangdong Provincial People's Hospital
Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer	NCT05983094	Breast Cancer Neoadjuvant The...	Utidelone Carboplatin Epirubicin Trastuzumab Pertuzumab	18 Years - 70 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organoid-based Functional Precision Therapy for Advanced Breast Cancer	NCT06102824	HER2-negative B... Advanced Breast...	Organoid-guided... Taxane Capecitabine Gemcitabine Vinorelbine Eribulin Anthracycline Carboplatin Utidelone Trastuzumab der... Sacituzumab gov...	18 Years - 80 Years	Guangdong Provincial People's Hospital
Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases	NCT05357417	Breast Cancer	utidelone Bevacizumab	18 Years -	Henan Cancer Hospital

Spots Global Cancer Trial Database for utidelone

Every month we try and update this database with for utidelone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for utidelone

Every month we try and update this database with for utidelone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for utidelone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.