Clinical trials: Stage 0 Breast Carcinoma
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.
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.
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
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 of 177Lu-RAD204 in participants with selected solid tumors, and to determine the MTD and/or recommended dose for future exploration.
- 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
- 6 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd
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
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.
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, Carcinoma
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
PRINCIPAL INVESTIGATORS Rakesh Patel, MD- Radiation Oncologist Peter Beitsch, MD- Breast Surgeon REGISTRY DESIGN Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in…
- Conditions
- Breast Cancer, Carcinoma, Lumpectomy, Ductal Carcinoma in Situ
- Trial name
- EXIBT (NCT00742222)
- Testing
- Electronic Brachytherapy, Intracavitary accelerated partial breast irradiation
- Where
- 8 sites in United States
- Volunteers
- 63 people
- Sponsor
- Xoft, Inc.
DCIS
The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing
This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions…
- Trial name
- AUS-PREDICT (NCT04916808)
- Testing
- DCISionRT Test
- Where
- 2 sites in Australia
- Volunteers
- 1,500 people
- Sponsor
- PreludeDx
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
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, 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
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.
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.
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.
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.
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
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.