Clinical trials: Breast
Breast Cancer
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male…
- Trial name
- NCT05738993
- Testing
- BCD-178, Perjeta
- Where
- 2 sites in Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants
This will be a prospective observational study aiming to investigate immune health biomarkers and fecal microbiota in 48-60 Filipino breastfed infants from birth to 12 months of age.
- Trial name
- NCT06708559
- Testing
- Breast-fed infants
- Where
- Philippines
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Breast Cancer
A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European…
- Trial name
- NCT05471648
- Testing
- 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection, Perjeta (US origin) 420 mg in 14 mL Injection
- Where
- Germany
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- EirGenix, Inc.
Breast Cancer, Early Detection of Cancer
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
- Trial name
- NCT04688086
- Testing
- Thermalytix
- Where
- India
- Volunteers
- 687 people, healthy volunteers welcome
- Sponsor
- Niramai Health Analytix Private Limited
Newborns, Breast Milk Expression
Newborns Supplemented With Gentle-UHT Donor Milk
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued…
- Trial name
- NCT04492579
- Testing
- Gentle-UHT donor human milk supplementation
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- LactaLogics, Inc
Metastatic Breast Cancer, Benign Breast Disease
China CellSearch Study
The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China.
- Trial name
- NCT01116869
- Where
- China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical, China
Neoplasms, Cancer
The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early.
- Trial name
- NCT03085888
- Where
- 35 sites in United States
- Volunteers
- 99,481 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Cancer, Lung, Cancer, Breast
Early Detection of Five Common Cancers Using the ctDNA Analysing Test
This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA).
- Conditions
- Cancer, Lung, Cancer, Breast, Cancer Liver, Cancer, Colorectal
- Trial name
- K-DETEK (NCT05227261)
- Where
- Vietnam
- Volunteers
- 9,057 people, healthy volunteers welcome
- Sponsor
- Gene Solutions
Breast Fat Grafting Retention
AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
Prospective, multi-center, non-randomized, open-label, post-market clinical study evaluating adipose graft retention over time from lipoaspirate processed using the AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System.
- Trial name
- AuraGen (NCT05258305)
- Testing
- AuraGen 1-2-3 with AuraClens
- Where
- 14 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Breast Augmentation, Mammoplasty
Evaluation of the Clinical Evolution of Breast Increase Using Prostheses
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics.
- Trial name
- NCT06079086
- Testing
- Breast Implants Lifesil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lifesil
Healthy Volunteers, Breast Cancer
Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
- Trial name
- CAM-VHH1 (NCT02683083)
- Testing
- [131I]-SGMIB Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Precirix
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
- Trial name
- NCT03491917
- Testing
- DBT plus S-View, FFDM alone
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Breast Enhancement
Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast
This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast.
- Trial name
- COBRA (NCT01299532)
- Testing
- Macrolane VRF30
- Where
- 5 sites in France, Sweden
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Breast Ptosis
A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System.
- Trial name
- NCT05665335
- Testing
- Renuvion APR System
- Where
- Greece
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Apyx Medical
Breast Cancer, Healthy Volunteers
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
Primary Objectives: To assess the excretion balance after oral and IV administration of [14C]-SAR439859 To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV administration of [14C]-SAR439859 and…
- Trial name
- NCT04940026
- Testing
- amcenestrant, [14C]-SAR439859 microtracer, [14C]-SAR439859
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Aging
The Impact of a Human Breast Milk Supplement on Epigenetic and Cellular Markers
This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers.
- Trial name
- NCT05297097
- Testing
- Trulacta breastmilk supplement
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- TruDiagnostic
Breast Cancer
A Drug-Drug Interaction Study of Rifampicin and Oral HRS-8080
A single-center, single-arm, open-label, fixed-sequence study is planned to enroll 18 healthy participants (6-9 females). The study consists of a screening period, an observation period, and a safety follow-up period.
- Trial name
- NCT07876596
- Testing
- HRS-8080, Rifampicin
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Breast Cancer, Peripheral Neuropathy
NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy
Phase 2, randomized, double-blind, Placebo-Controlled, Multiple Dose Study for the treatment of Patients with Metastatic Breast Cancer.
- Trial name
- NCT04675450
- Testing
- NBP Softgel Capsules
- Volunteers
- healthy volunteers welcome
- Sponsor
- Conjupro Biotherapeutics, Inc.
Breast Cancer
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects
- Trial name
- NCT03845907
- Testing
- Gen 1B, Gen 1
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Seno Medical Instruments Inc.