Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Carcinoma, Renal Cell

Liver Neoplasms

Head and Neck Neoplasms

Skin Neoplasms

Mouth Neoplasms

Salivary Gland Neoplasms

Laryngeal Diseases

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Rectal Neoplasms

Bile Duct Neoplasms

Tongue Neoplasms

Laryngeal Neoplasms

Urologic Neoplasms

Lip Neoplasms

Tonsillar Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Disease Attributes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Kidney Neoplasms

Kidney Diseases

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Neoplasms, Cystic, Mucinous, and Serous

Tongue Diseases

Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Pharyngeal Diseases

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Oral Cancer

Adenocarcinoma of the Appendix

Tongue Cancer

Mucoepidermoid Carcinoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

Mitogens

Six dose levels have been selected for evaluation in the Phase I part of the study: 0.3, 0.6, 1.2, 2.4, 3.6, and 4.8 mg/kg of A166

HER2 positive (Immunohistochemistry (IHC) 2+ with fluorescence in situ hybridization (FISH) confirmation and Immunohistochemistry (IHC) 3+) breast cancer. Treatment with A166 at recommended Phase II dose.

HER2 positive (Immunohistochemistry (IHC) 2+ with fluorescence in situ hybridization (FISH) confirmation and Immunohistochemistry (IHC) 3+) gastric cancer. Treatment with A166 at recommended Phase II dose.

HER2 low expressing (Immunohistochemistry (IHC) 1+ and IHC 2+ without fluorescence in situ hybridization (FISH) confirmation) breast cancer. Treatment with A166 at recommended Phase II dose.

All cancers other than breast cancer with low HER2 expression (Immunohistochemistry (IHC) 1+ and IHC 2+ without fluorescence in situ hybridization (FISH) confirmation) and HER2 positive (IHC2+ with FISH confirmation and Immunohistochemistry (IHC) 3+) cancers other than breast and gastric cancer. Treatment with A166 at recommended Phase II dose.

A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells.

A166

Jordi Rodon Ahnert, MD, PhD

Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Patients will receive study drug as a single IV infusion. Cycles will continue until disease progression or unacceptable toxicity.

This is an open-label, Phase I-II, first-in-human (FIH) study for A166 as monotherapy in HER2-expressing patients who progressed on or did not respond to available standard therapies. Patients enrolled in this Phase III study must have documented HER2 positivity defined as positive on in situ hybridization (ISH) or next-generation sequencing (NGS) or HER2 expression, defined as at least 1+ by validated immunohistochemistry (IHC) test. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease. Patients will receive study drug as a single IV infusion at the prescribed dose level in each treatment cycle. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II).

Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene

A Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies

Number of patients with dose limiting toxicities

Klus Pharma Inc.

Analgesics

Nefopam

Analgesics, Non-Narcotic

Normal Saline

Hyo-Seok Na

Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. The investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.

Effectiveness of Nefopam in Breast Cancer Surgery

Seoul National University Bundang Hospital

Clinical professor

Carcinoma, Intraductal, Noninfiltrating

breast cancer patients, intervention = patient navigation

two trained patient navigators will admit breast cancer patients to HCM, navigate them from admission to commencement of first treatment and will collect all pertinent epidemiological data and variables

patient navigation

renato cagnacci neto, MD, MSc

The objective of this observational study is to introduce a patient navigation system within the breast cancer unit at Hospital Central de Maputo (MOZ) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. The primary inquiries it seeks to address are as follows:

* Can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment?
* Does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? Participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.

-General Objective: To implement an oncological navigation platform for breast cancer patients receiving treatment at Maputo Central Hospital (HCM) over a proposed period of 12 months after project approval by the local IRB.

-Specific Objectives:

* Develop an oncological patient navigation system for breast cancer patients treated at HCM.
* Establish a prospective cohort of navigated breast cancer patients (with invasive or ductal carcinoma in situ) treated at HCM in 2024-25.
* Collect diverse epidemiological data from navigated patients during the proposed study period.
* Compare the time interval (in days) between admission to HCM and initiation of cancer treatment (surgery or systemic treatment) among patients in this cohort versus patients already treated in the service with available data in the National Cancer Registry (NCR).
* Compare overall survival between patients in this cohort and a locally published historical cohort from 2020.

A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients

The Journey of Women With Breast Cancer in Mozambique: What is the Best Path? A Prospective Cohort With Patient Navigation as an Intervention to Reduce Treatment Disparities

we will share all collected IPD with any researchers that contact the PI

time interval (in days) between admission to HCM and initiation of cancer treatment (surgery or systemic treatment)

overall survival (in months) of navigated breast cancer patients

AMERICAN SOCIETY FOR CLINICAL PATHOLOGY

Hospital Central de Maputo

Eduardo Mondlane University

M.D. Anderson Cancer Center

Renato Cagnacci Neto

Principal Investigator

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Pharmaceutical Solutions

Standard of care echocardiographic follow-up

Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer patients

Comprehensive echocardiographic follow-up

Simplified echocardiographic follow-up for identification of CRTCD in breast cancer patients

Simplified echocardiographic follow-up

Espen Holte, MD. PhD

Havard Dalen, MD, PhD

Rune Wiseth, MD, PhD

Espen Holte, MD, PhD

TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).

Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.

Cancer treatment related cardiac dysfunction (CTRCD) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart.

CTRCD, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. By precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. However, guideline advocated analyses of cardiac function (EF and GLS) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. Furthermore, test-retest variability for both EF and GLS are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity.

The study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. The study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (EF) and global longitudinal strain (GLS) can improve the diagnostic precision.

Breast cancer patients referred for follow-up at the echocardiography will be included.

Patients will be randomized 1:1 to A) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the European guidelines and as clinical practice or B) echocardiographic examinations focusing on the ventricles.

Subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.

Randomization 1:1 to two different modes of follow-up

TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

Technology Revising Ultrasound Solutions for Tomorrow - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

Risk classification for identification of CTRCD

Test-retest variability of systolic left ventricular size and function

Test-retest variability systolic left ventricular size and function

Test-retest variability of diastolic left ventricular function

Test-retest variability of diastolic left ventricular size and function

Test-retest variability of right ventricular size and function

Time used for echocardiographic examination

Cancer treatment related cardiac dysfunction

St. Olavs Hospital

Norwegian University of Science and Technology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene	NCT03602079	HER2-positive B... HER2 Gene Mutat... HER-2 Gene Ampl... HER2 Positive G... Salivary Gland ... Salivary Gland ... Salivary Gland ... Salivary Gland ... Lung Cancer Colo-rectal Can... Rare Diseases Solid Tumor Recurrent Gastr... Recurrent Colon... Recurrent Breas... Head and Neck C... Head and Neck C... Bladder Cancer Cervical Cancer Liver Cancer Bile Duct Cance... Urologic Cancer Pancreatic Canc... Prostate Cancer Recurrent Prost... Rectal Cancer Recurrent Ovari... Recurrent Renal... Rectal Cancer S... Rectal Cancer S... Rectal Cancer S... Skin Cancer Mouth Cancer Lip Cancer Stag... Tongue Cancer Breast Neoplasm... Larynx Cancer Tonsil Cancer Palate Cancer Mucoepidermoid ... Primary Periton... Mucinous Adenoc... Mucinous Breast... Cholangiocarcin...	A166	18 Years -	Klus Pharma Inc.
Effectiveness of Nefopam in Breast Cancer Surgery	NCT02949310	Breast Neoplasm...	Nefopam Normal Saline	20 Years -	Seoul National University Bundang Hospital
Effectiveness of Nefopam in Breast Cancer Surgery	NCT02949310	Breast Neoplasm...	Nefopam Normal Saline	20 Years -	Seoul National University Bundang Hospital
A Prospective Cohort With Patient Navigation as an Intervention for Breast Cancer Patients	NCT06257888	Breast Neoplasm...	patient navigat...	18 Years -	AC Camargo Cancer Center
TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography	NCT06310330	Breast Neoplasm...	Comprehensive e... Simplified echo...	18 Years -	Norwegian University of Science and Technology

Spots Global Cancer Trial Database for breast neoplasm malignant primary