Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Bortezomib

Proteasome Inhibitors

Antineoplastic Agents, Immunological

Trastuzumab and velcade are used according standard procedure

Combination of trastuzumab and PS-341

Fatima Cardoso, MD

The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.

Phase 1 study to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) given either weekly or 3-weekly.

Additionally, hints about efficacy of the combination will be looked upon.

PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2

A Phase I, Open Label, Dose-escalating Study of the Proteasome Inhibitor PS-341 in Combination With Two Schedules of Herceptin, in Patients With Advanced Breast Cancer That Overexpresses HER-2

Combination of Velcade and Herceptine in breast metastatic patients

safety and tolerability of combinaison before recurrence of metastatic breast cance

Tolerability and safety of combination of velcade and Herceptine

Jules Bordet Institute

Dr Fatima Cardoso

Fulvestrant

Anastrozole

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Aromatase Inhibitors

Enzyme Inhibitors

Anastrozole 1 mg PO QD Fulvestrant 500mg IM d1,15, 29 and 4 weeks after

Adding fulvestrant to the standard endocrine therapy, anastrozole

Xichun Hu, MD.PhD.

This research is designed to investigate whether the addition of fulvestrant 500mg to anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced breast cancer.

Anastrozole is the standard first-line endocrine treatment for patients with hormonal receptor positive advanced breast cancer. It has been proven that the addition of fulvestrant 250mg can enhance PFS of anastrozole monotherapy according to SWOG0226 study. However, the optimal recommended dose of fulvestrant for patients with advanced breast cancer is 500mg worldwide according to CONFIRM study. The investigator designed this research to investigate whether high dose fulvestrant can further improve efficacy of anastrozole monotherapy.

Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC

An Open-label, Multi-center, Randomized Phase II Study of Fulvestrant Anastrozole Combination Versus Anastrozole Alone in Patients With Luminal A-like Postmenopausal Advanced Breast Cancer

Fudan University

M.D. Ph. D.

Amino Acids

Vinorelbine

Afatinib

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Patients will receive BIBW 2992 and vinorelbine chemotherapy. BIBW 2992: 40 mg oral (tablet) once daily Vinorelbine: 25 mg/m² on days 1 \& 8 in a 3-weekly course, intravenous, short infusion of about 10 minutes

BIBW 2992 in combination with vinorelbine

Joachim Bischoff, MD

This open-label, single-arm, multicentre phase II trial will be performed in patients with intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and one first-line therapy in the metastatic setting.

The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are warranted.

Patients will be followed until progression. After progression, for the purpose of analysing overall survival, information on vital status and subsequent treatment will be collected.

The primary objective is to determine the 6-month progression free survival rate of BIBW 2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast cancer.

BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.

BIBW 2992 (Afatinib) and Vinorelbine

Single-arm, Open-label, Multicentre Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) in Combination With Vinorelbine for the Treatment of Patients With Metastatic Breast Cancer With Intermediate HER2 Expression (HER2 2+ by Immunohistochemistry, Fluorescence In-situ Hybridisation (FISH) Negative) After Failure of First-line Therapy in the Metastatic Setting and Having Been Pre-treated With Anthracyclines

The primary objective is to determine the 6-month Progression free survival rate of BIBW 2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast cancer. The analysis will be based upon the evaluation of tumour imaging. Disease progression will be evaluated according to the RECIST 1.1 criteria.

Objective Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1), Time-to-Progression and Overall Survival.

Safety will be evaluated as indicated by number, intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.0.

Boehringer Ingelheim

University of Magdeburg

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Bavituximab

Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.

This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.

Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer

A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer

Peregrine Pharmaceuticals

A.J. Leyco, RN/Associate Director, Clinical Affairs

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hyperthermia

Fever

Mesothelioma

Mesothelioma, Malignant

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenoma

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mesothelioma

Cisplatin

cohorte 2: 12.5 mg/m2 of cisplatin (once)

PITHAC: Cisplatin (Cisplatine Teva®) at a dose between 7.5 and 70 mg/m2 of body surface at a temperature of 39±1°C

Cisplatine Teva®

Jean-Yannis H Perentes

Séverine Devesa-Perez

Jean-Yannis PERENTES

Jean Yannis PERENTES

Jean-Yannis Perentes

Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD).

Adverse events: the evaluation of the safety of cisplatin administered by PITHAC is the primary endpoint of both parts of the study Cisplatin administration will be performed on D0. Postoperative pain management according to the Enhanced Recovery After Surgery program following the surgical procedure.

Dyspnoea score will be scored at screening, and every day until D10 and checked one last time at D30 using the CR-10 scale.

Chest X-ray will be performed at screening, D0, 24h post intervention, D10 and D30.

Monitoring of adverse events (AEs), serious and non-serious, will be conducted throughout the study from the surgery.

Blood samples for cisplatin pharmacokinetics PK will be performed on D0 pre-intervention, 12h post intervention, 24h and 48h post intervention.

Translational blood tests for immune profiling will be performed on D0 pre-intervention, D10 and D30. Translational blood tests on inflammatory cytokine assessment will be performed on D0 pre-intervention, 12h post intervention, 24h, 48h and on D10 and D30. Tissue biopsy for free cisplatin PK and Pleural biopsy for tissue immune infiltration will be performed on D0 before and after treatment administration.

Malignant pleural effusion (MPE) assessment: Immune environment and neoantigen landscape will be collected before the PITHAC procedure and via the indwelling pleural catheter (D0, at hospital discharge and D10).

STATISTICAL METHODS:

PART A: Dose escalation and MTD determination: The sample size is set to determine the MTD by using the 3+3 design. Cohorts of 3-6 patients will be recruited sequentially at each of the cisplatin doses. The total number of patients is expected to be 12 with a maximum of 24, depending on the level of MTD. If there are patients who are not evaluable for the objectives in the study, additional patients will be enrolled. Patients not evaluable will be replaced but not withdrawal from the study.

Primary Analysis: dose limiting toxicities; To determine the maximum tolerated dose (MTD) of cisplatin administered with PITHAC, the primary study outcome is the occurrence of Dose Limiting Toxicities (DLT). The number and proportion of patients with DLTs will be presented overall and by dose and will be plotted vs dose. The MTD will be graphically displayed. Secondary Analyses: safety profile of cisplatin administered with PITHAC: The safety analysis will be performed on the safety population. -Treatment emergent AE frequencies will be summarised by system organ class and preferred term (MedDRA) overall and by dose. AEs will also be tabulated by system organ class and preferred term including maximum severity grade according to the NCI-CTCAE criteria version 5 and relationship to treatment. Incidence of treatment discontinuations due to AEs and SAEs will be summarised overall and by dose. -Safety Lab parameters and vital signs at pre-treatment and post-treatment and corresponding changes from pre-treatment will be presented by dose as descriptive statistics. Efficacy analysis will be performed on efficacy population. Dyspnoea will be scored from screening to D30. Dyspnoea score will be presented at pre- and post-treatment and change from pre- to post-treatment will be presented as descriptive statistics by dose. The pleural infusion index will be determined by comparing chest X-rays before treatment (D0) and post-treatment at D1, D10 and 30 days and pleurodesis or indwelling catheter placement. The index will be presented at pre- and post-treatment and change from pre- to post-treatment will be presented as descriptive statistics by dose. Exploratory endpoints: exploratory analyses will be performed by tissue immunostaining and image analysis will be carried out. The concentration of cisplatin in tumor tissue at the beginning and end of mild hyperthermia PITHAC will be evaluated by Laser Ablation Inductively Coupled Plasma Mass Spectrometry (LA-ICP-MS) that will allow visualization of cisplatin distribution and penetration in tumor biopsies. The correlation between cisplatin concentration and penetration into tumor tissue and clinical response will be explored. Immune infiltration in tumor tissues will be assessed by immunostainings and image analysis will be performed. Immune cells proportions in peripheral blood before and after PITHAC at D0, 10 and 30 will be explored using DURAClone Panels for flow cytometry.

PART B: Expansion: Determination of Sample Size: the sample in the expansion phase is not based on a formal hypothesis. To evaluate the safety of cisplatin administered by PITHAC at the RD and undertake an initial evaluation of efficacy, a total of 15 patients will be enrolled in this exploratory part of the study. Statistical criteria of termination of trial: there are no statistical criteria of termination of the trial in this part of the study.

Primary Analysis: dose limiting toxicities; To determine the maximum tolerated dose (MTD) of cisplatin administered with PITHAC, the primary study outcome is the occurrence of Dose Limiting Toxicities (DLT). The number and proportion of patients with DLTs will be presented overall and by dose and will be plotted vs dose. The MTD will be graphically displayed. Secondary Analyses: safety profile of cisplatin administered with PITHAC: The safety analysis will be performed on the safety population. -Treatment emergent AE frequencies will be summarised by system organ class and preferred term (MedDRA) overall and by dose. AEs will also be tabulated by system organ class and preferred term including maximum severity grade according to the NCI-CTCAE criteria version 5 and relationship to treatment. Incidence of treatment discontinuations due to AEs and SAEs will be summarised overall and by dose. -Safety Lab parameters and vital signs at pre-treatment and post-treatment and corresponding changes from pre-treatment will be presented by dose as descriptive statistics. Efficacy analysis will be performed on efficacy population. Dyspnoea will be scored from screening to D30. Dyspnoea score will be presented at pre- and post-treatment and change from pre- to post-treatment will be presented as descriptive statistics by dose. The pleural infusion index will be determined by comparing chest X-rays before treatment (D0) and post-treatment at D1, D10 and 30 days and pleurodesis or indwelling catheter placement. The index will be presented at pre- and post-treatment and change from pre- to post-treatment will be presented as descriptive statistics by dose. Exploratory endpoints: exploratory analyses will be performed by tissue immunostaining and image analysis will be carried out. The concentration of cisplatin in tumor tissue at the beginning and end of mild hyperthermia PITHAC will be evaluated by Laser Ablation Inductively Coupled Plasma Mass Spectrometry (LA-ICP-MS) that will allow visualization of cisplatin distribution and penetration in tumor biopsies. The correlation between cisplatin concentration and penetration into tumor tissue and clinical response will be explored. Immune infiltration in tumor tissues will be assessed by immunostainings and image analysis will be performed. Immune cells proportions in peripheral blood before and after PITHAC at D0, 10 and 30 will be explored using DURAClone Panels for flow cytometry.

QUALITY ASSURANCE AND CONTROL: all data collected will be coded and recorded on the RedCap search software. The conformity of eCRF with protocol specifications is checked and validated by the SI and/or qualified individuals, according to ICH GCP. Case Report Forms (eCRF): electronic data entry will be performed via a web-based application (REDCap). Security passwords will be provided to each properly trained investigator. An eCRF for data collection will be developed in Redcap. The REDCap database will record the data obtained with the coding number specific to each patient: this code will consist of PITHAC-01, PITHAC-02 etc.... A specific subject identification log will be compiled to record the identifying information of enrolled participants, providing the link to individual attributed codes. This document (word file) will be kept separately, it will be password protected and saved in a secure directory on a CHUV server. At the end of the project, the subject identification log will be kept by the principal investigator. Best practices will be adopted to ensure that data are complete, reliable, and processed correctly, thus providing high-quality data, keeping the number of errors and missing data as low as possible, and gathering a maximum amount of accurate data for analysis. The data collected through RedCap® will be automatically checked by the implementation of data validation rules (e.g., data-type, maximum/minimum range, missing data checks, and other logical tests) and automatic alerts. Specification of source documents: study monitors will perform ongoing source data verification to confirm that critical protocol data (i.e., source data) entered into the eCRFs by authorized site personnel are accurate, complete, and verifiable from source documents. Source documents (paper or electronic) are those in which patient data are recorded and documented for the first time. They include, but are not limited to, hospital records, clinical and office charts, laboratory notes, memoranda, evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies of transcriptions that are certified after verification as being accurate and complete, X-rays, patient files, and records kept at pharmacies, laboratories, and medico-technical departments involved in the clinical trial. The Investigator must keep a subject file (medical file, original medical records) electronically (SOARIAN/ARCHIMEDE) for every subject included in the trial. All documents containing source data must be filed in the electronic patient file. Electronic subject files (SOARIAN/ARCHIMEDE) will be accessible to the Monitor to perform source data verification. Record keeping / archiving: the SI will retain copies of the patient trial records (CRFs, patient informed consent statement, drug inventory logs and all other information collected during the trial) and documentation until at least 10 years after the termination of the trial.It must be available for review by the Monitor and must be ready for Sponsor audit as well as for inspection by Competent Authorities during and after the trial and must be safely archived for at least 10 years (or per local requirements or as otherwise notified by the Sponsor) after the end of the trial. The documents to be thus archived include the Subject Identification List and the signed subject ICFs.

Safety Monitoring (Dose Escalation Part): a Trial Safety Board (TSB) will be constituted for the part A of the trial, being responsible for maintaining the scientific integrity of the trial and safety of patients. This Board will review the DLTs of each cohort and decide whether to escalate or not to the next dose level (next cohort). Details on the dose escalation design, rules, and the role of the TSB are provided in the DEP. The TSB will give the green light to start part B after recommended dose confirmation, based on safety and efficacy data of all patients enrolled in part A. For Part B, the responsibility for the safety of the individual patient lies with the investigator and the SI. Clinical Trial Monitoring: clinical monitoring activities have the ultimate purpose to guarantee that the rights and well-being of human subjects are protected, that the reported study data are accurate, complete and verifiable from source documents, and that the conduct of the study complies with the latest approved version of the study protocol, with ICH-GCP guidelines and applicable regulations .

Open-label, non-randomised monocentric Phase I clinical trial study with cisplatin dose escalation administered by PITHAC.

Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration

Phase I Clinical Trial Testing the Dose Escalation and Expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration for the Management of Pleural Carcinosis

Tissue immune infiltration will be assessed by comparing penetration depth and resulting immune infiltrate in pleural biopsy specimens at the beginning and at the end of PITHAC.

The correlation between plasma concentrations of administered intrapleural cisplatin by PITHAC and acute secondary side effects will be evaluated.

Tissue distribution of free cisplatin will be compared in pleural biopsy specimens at the beginning and at the end of PITHAC by gaz phase chromatography.

Correlation between treatment outcome, percentage of cancer cell death, cisplatin concentration in pleural biopsies, release of pro-inflammatory proteins and the activation status of effector T-cell will be assessed.

Assess the immune environment and immune responses mediated by neoantigen directed cytotoxic T cells (neoantigen landscape) in patient malignant pleural effusion (MPE) before and after PITHAC ((D0, 72h post intervention, Day 10 and D30).

In order to determine the maximum tolerated dose (MTD) of cisplatin administered by PITHAC, the primary study outcome will be the occurrence of Dose Limiting Toxicities (DLT).

Safety profile of cisplatin administered by PITHAC will be assessed by the incidence of Adverse Events and Serious Adverse Events according to NCI-CTCAE criteria (v5). Incidence and severity of intraoperative and post-operative complications will be measured using the Clavien-Dindo classification up to 30 days after the intervention.

Safety profile of cisplatin administered by PITHAC will be assessed by the incidence of Adverse Events and Serious Adverse Events according to NCI-CTCAE criteria (v5). Incidence and severity of intraoperative and post-operative complications will be measured using the Clavien-Dindo classification up to 30 days after the intervention.

Safety profile of cisplatin administered with moderate hyperthermic PITHAC will be assessed by the incidence of Adverse Events and Serious Adverse Events according to NCI-CTCAE criteria (v5).

Dyspnoea will be scored every day until Day 10 and re-evaluated at Day 30 after the procedure

The pleural effusion index will be determined by comparing chest X-rays before, 24 hours (Day 0), at Day 10 and at Day 30 after PITHAC and pleurodesis or indwelling catheter placement

Dyspnoea will be scored every day until Day 10 and re-evaluated at Day 30 after the procedure.

The pleural effusion index will be determined by comparing chest X-rays before PITHAC procedure, 24 hours after, at Day 10 and Day 30 after PITHAC and pleurodesis or indwelling catheter placement.

Dr Jean Yannis PERENTES

Sponsor-Investigator

Uterine Cervical Neoplasms

Small Cell Lung Carcinoma

Adenocarcinoma

Triple Negative Breast Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Glioblastoma

Head and Neck Neoplasms

Carcinoma, Renal Cell

Carcinoma, Hepatocellular

Urinary Bladder Neoplasms

Endometrial Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Male Urogenital Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Urinary Bladder Diseases

Small Cell Lung Cancer

Pancreatic Cancer

Renal Cell Carcinoma

Neuroepithelioma

Irinotecan

Antibodies

Sacituzumab govitecan

Immunoglobulins

Immunoconjugates

Immunologic Factors

Participants will receive sacituzumab govitecan-hziy (SG) 8 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

Participants will receive SG 10 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

Participants will receive SG 12 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

Participants will receive SG 18 mg/kg of body weight via intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity.

Administered via intravenous (IV) infusion

Sacituzumab Govitecan-hziy (SG)

Gilead Study Director

The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I.

Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).

The outcome measures are planned to be assessed up to the data cutoff date. Following the data cutoff date, the participants will either stay on the study and will be followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data will be collected after the data cutoff date.

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer

A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:

* Fatal
* Life-threatening
* Disabling/incapacitating
* Results in hospitalization or prolongs a hospital stay
* A congenital abnormality
* Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above

Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population.

Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP).

ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.

ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.

Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only.

Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, duration of response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.

Time to response was defined as the time from the first dose to the first documentation of response (PR or CR). Per planned analysis, time to response by ICR was assessed for the TNBC Target Population only.

Time to response was defined as the time from the first dose to the first documentation of response (PR or CR). Per planned analysis, time to response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.

Clinical benefit rate (CR+PR+\[stable disease (SD) ≥ 6 months\]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months. SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier. Per planned analysis, CBR by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2	NCT00199212	Carcinoma Breas...	Combination of ...	18 Years -	Jules Bordet Institute
Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC	NCT02140437	Carcinoma Breas...	Fulvestrant Anastrozole	18 Years - 80 Years	Fudan University
BIBW 2992 (Afatinib) and Vinorelbine	NCT01531764	Carcinoma Breas...	BIBW 2992 in co...	18 Years -	University of Magdeburg
Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer	NCT00669565	Carcinoma Breas...	Bavituximab	18 Years -	Peregrine Pharmaceuticals
Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC	NCT02140437	Carcinoma Breas...	Fulvestrant Anastrozole	18 Years - 80 Years	Fudan University
Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration	NCT06281860	Mesothelioma, M... Carcinoma, Non-... Carcinoma Breas... Ovarian Cancer Esophageal Canc... Gastric Cancer	Cisplatine Teva...	18 Years -	Centre Hospitalier Universitaire Vaudois
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer	NCT01631552	Gastric Adenoca... Esophageal Canc... Hepatocellular ... Non-small Cell ... Small Cell Lung... Ovarian Epithel... Carcinoma Breas... Hormone-refract... Head and Neck C... Renal Cell Canc... Urinary Bladder... Cervical Cancer Endometrial Can... Glioblastoma Mu... Triple Negative... Pancreatic Canc...	Sacituzumab Gov...	18 Years -	Gilead Sciences
BIBW 2992 (Afatinib) and Vinorelbine	NCT01531764	Carcinoma Breas...	BIBW 2992 in co...	18 Years -	University of Magdeburg
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer	NCT02183805	Carcinoma Breas...	Abraxane,Cyclop...	18 Years - 65 Years	Sun Yat-sen University
Steroid Aromatase Inhibitors Versus Progestogens for nSAID-resistanced Late Stage Breast Cancer	NCT02161315	Carcinoma Breas...		-	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for carcinoma breast stage iv