Clinical trials: Breast Cancer Stage 0
Breast Cancer
Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure
This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.
- Trial name
- NCT00380952
- Testing
- Dune Device
- Where
- 9 sites in Israel
- Volunteers
- 300 people
- Sponsor
- Dune Medical Devices
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
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.
Breast Cancer
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor…
- Trial name
- NCT05950945
- Testing
- Trastuzumab Deruxtecan
- Where
- 88 sites in United States, Australia and 8 more
- Volunteers
- 250 people
- Sponsor
- Daiichi Sankyo
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
Breast Neoplasms
A Registry Study of Breast Microseed Treatment
For women diagnosed with early stage breast cancer, lumpectomy followed by radiation is a common treatment option. Radiation treatment is typically delivered to the whole breast, five times per week, for anywhere from 3 to 8…
- Trial name
- NCT02701244
- Testing
- Permanent Breast Seed Implant (PBSI)
- Where
- 3 sites in United States
- Volunteers
- 420 people
- Sponsor
- Concure Oncology-Breast Microseed Inc.
PDL1 Gene Mutation, Non Small Cell Lung Cancer
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to…
- Conditions
- PDL1 Gene Mutation, Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), TNBC, Triple Negative Breast Cancer
- Trial name
- NCT06305962
- Testing
- 177Lu-RAD204
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd
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.
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
Sarcoma, Melanoma
Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5
The purpose of this research study is to get information from volunteers without cancer and patients with cancer who have received a new investigational study agent called, "[F-18] RGDK5," to evaluate biodistribution and…
- Conditions
- Sarcoma, Melanoma, Lung Cancer, Breast Cancer
- Trial name
- K5 (NCT00743353)
- Testing
- F-18 RGD-K5
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Siemens Molecular Imaging
Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive…
- Trial name
- NCT06439771
- Testing
- YL202 should be intravenously infused
- Where
- China
- Volunteers
- 180 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
Ductal Carcinoma In Situ
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)
The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2…
- Trial name
- NCT00669747
- Testing
- Carboplatin i.d. Days 1 & 15, Carboplatin i.d. Day 1; Normal Saline i.d. Day 15, Normal Saline
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Windy Hill Medical, Inc.
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.
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
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
- Trial name
- Pivotal (NCT00749931)
- Testing
- MarginProbe, Lumpectomy
- Where
- 21 sites in United States, Israel
- Volunteers
- 664 people
- Sponsor
- Dune Medical Devices
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
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.
DCIS
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
- Trial name
- DCIS (NCT00586326)
- Testing
- MammoSite Radiation Therapy System
- Where
- 12 sites in United States
- Volunteers
- 133 people
- Sponsor
- Hologic, 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.