Clinical trials: Stage 0 Breast Cancer
Locally Advanced Breast Cancer, Unresectable Breast Carcinoma
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination…
- Conditions
- Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06827236
- Testing
- BNT323, BNT327
- Where
- 81 sites in United States, Australia and 9 more
- Volunteers
- 380 people
- Sponsor
- BioNTech SE
Invasive Ductal Carcinoma, Ductal Carcinoma in Situ
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer.
- Trial name
- NCT01644669
- Testing
- Intra-operative Radiation Therapy - IORT
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Xoft, Inc.
Recurrent or Metastatic Solid Tumors
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma…
- Trial name
- NCT06330064
- Testing
- Ifinatamab deruxtecan
- Where
- 120 sites in United States, Argentina and 16 more
- Volunteers
- 680 people
- Sponsor
- Daiichi Sankyo
Primary Invasive Malignant Neoplasm of Female Breast, Carcinoma Breast
Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
- Conditions
- Primary Invasive Malignant Neoplasm of Female Breast, Carcinoma Breast, Breast Cancer Female, Carcinoma, Ductal, Breast
- Trial name
- NCT03113825
- Testing
- Investigational Imaging device, AVB-620
- Where
- 13 sites in United States
- Volunteers
- 92 people
- Sponsor
- Avelas Biosciences, Inc.
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult
A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Trial name
- NCT06273852
- Testing
- PBA-0405
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pure Biologics S.A.
Invasive Ductal Carcinoma, Ductal Carcinoma In Situ
An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"
The purpose of this trial is to assess the efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer.
- Trial name
- NCT04349111
- Testing
- Intra-operative Radiation Therapy - IORT
- Sponsor
- Xoft, Inc.
Breast Cancer, Breast Cancer Invasive
Specimen PET-CT Imaging for Intraoperative Margin Assessment in Breast Cancer
Breast-conserving surgery (BCS) has become the standard-of-care for surgical management of the majority of women with early-stage breast cancer.
- Conditions
- Breast Cancer, Breast Cancer Invasive, Breast Cancer in Situ
- Trial name
- BrIMA (NCT04999917)
- Testing
- high-resolution PET-CT specimen imaging.
- Where
- Belgium
- Volunteers
- 206 people
- Sponsor
- XEOS Medical
Breast Cancer, DCIS
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by…
- Conditions
- Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
- Trial name
- NCT05900986
- Testing
- LS301-IT 0.025 mg/kg, LS301-IT 0.05 mg/kg, LS301-IT 0.075 mg/kg
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Integro Theranostics
Breast Cancer, Preneoplastic Conditions
The Breast Duct: Pilot Study of Genomic Sequencing of Exfoliated Ductal Cells Obtained Through Endoscopy and Lavage
The objective of this study is to determine whether we can use minimally invasive techniques to gain access to exfoliated ductal epithelial cells for whole genome sequencing. 1.
- Conditions
- Breast Cancer, Preneoplastic Conditions, Ductal Carcinoma in Situ
- Trial name
- NCT02121873
- Testing
- Nipple aspirator, Ductal lavage microcatheter, Blood draw
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Atossa Therapeutics, Inc.
Breast Cancer
Changes in Biomarkers of Cancer in Women With Breast Cancer and Without Evidence of Disease Who Were Given PhytoMed™
The purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and…
- Trial name
- NCT01819948
- Testing
- PhytoMed™
- Where
- 5 sites in Spain
- Volunteers
- 46 people
- Sponsor
- Phytogen Medical Foods S.L.
Solid Tumor
Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose…
- Trial name
- NCT04541108
- Testing
- Rilvegostomig, Volrustomig, Sabestomig
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Presage Biosciences
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0111 when administered intratumorally in…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Trial name
- NCT06700070
- Testing
- PBA-0111
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Pure Biologics S.A.
Solid Tumor, Colon Carcinoma
PET-imaging of Two Vartumabs in Patients With Solid Tumors
VARTUTRACE is a first-in-human PET/CT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS).
- Conditions
- Solid Tumor, Colon Carcinoma, Rectal Carcinoma, Osteosarcoma
- Trial name
- VARTUTRACE (NCT06645808)
- Testing
- 89Zr-DFO-N-Suc-F8scFv, 89Zr-DFO-N-Suc-C9scFv, PET/CT scan
- Where
- Netherlands
- Volunteers
- 32 people
- Sponsor
- Var2 Pharmaceuticals
Solid Tumour
CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia
This is a multi-center, open-label Phase 0 Master Protocol in Australia designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumour microenvironment (TME) when administered intratumourally in…
- Trial name
- NCT04891718
- Testing
- MVC-101, Nivolumab, MVC-101 + Nivolumab
- Where
- 3 sites in Australia
- Sponsor
- Presage Biosciences
Invasive Breast Cancer Early Stages, Ductal Carcinoma In Situ, DCIS
Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy
The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on…
- Trial name
- SHIELD (NCT07711847)
- Testing
- VENUS SHELL™ immobilization device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HeroSupport SA
Breast Cancer
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
- Trial name
- NCT02391194
- Testing
- AVB-620
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Avelas Biosciences, Inc.
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
Hot Flashes
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but…
- Trial name
- NCT06440967
- Testing
- Fezolinetant, Tamoxifen, Aromatase inhibitor
- Where
- 110 sites in Canada, Czechia and 9 more
- Volunteers
- 982 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
DCIS, Stage 0 Breast Cancer
The PREDICT Registry:
This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions.
- Conditions
- DCIS, Stage 0 Breast Cancer, Ductal Breast Carcinoma In Situ
- Trial name
- NCT03448926
- Testing
- Treatment recommendation surveys, 7-gene biosignature
- Where
- 30 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- PreludeDx