Clinical trials: Invasive Breast Carcinoma
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.
Breast Cancer
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint.
- Trial name
- NCT00127933
- Testing
- capecitabine [Xeloda], Taxotere, Herceptin (HER2-neu positive patients only)
- Where
- 38 sites in United States
- Volunteers
- 157 people
- Sponsor
- Hoffmann-La Roche
Benign Breast Conditions; Breast Fibroadenomas
American Breast Laser Ablation Therapy Evaluation
The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ device and method in real world application.
- Trial name
- ABLATE (NCT00807924)
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Novian Health Inc.
Neoplasms, Breast
Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.
This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel.
- Trial name
- NCT00524303
- Testing
- Trastuzumab, Paclitaxel, FEC75
- Where
- 23 sites in United States
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
Solid Tumors, Head and Neck Carcinoma
Milademetan in Advanced/Metastatic Solid Tumors
Phase 2, multicenter, single-arm, open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that…
- Conditions
- Solid Tumors, Head and Neck Carcinoma, Cholangiocarcinoma, Sarcoma
- Trial name
- NCT05012397
- Testing
- RAIN-32
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Rain Oncology Inc
Breast Cancer
Breast Cancer Index (BCI) Registry
The purpose of the Breast Cancer Index (BCI) Registry study is to conduct a large scale, population-based prospective registry to evaluate long-term clinical outcome, clinical impact, medication adherence and quality of life in…
- Trial name
- NCT04875351
- Testing
- Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test
- Where
- 105 sites in United States
- Volunteers
- 3,465 people
- Sponsor
- Biotheranostics, Inc.
Breast Cancer
An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants
This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.
- Trial name
- NCT02535026
- Where
- 4 sites in Peru, Uruguay
- Volunteers
- 580 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Ovarian Cancer
Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study
This Pilot Study is to investigate the tear proteins in a multitude of cancer types and indulge in biomarker discovery to manufacture simple, accurate, and novel tear-based diagnostic tests.
- Conditions
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
- Trial name
- NCT05223218
- Testing
- Schirmer strip, a Class I Medical Device typically used to test for dry eye.
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Namida Lab
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
HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy，This study will examine…
- Trial name
- NCT06126640
- Testing
- SHR-A1811, Trastuzumab Emtansine
- Where
- 2 sites in China
- Volunteers
- 1,615 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Triple Negative Breast Cancer
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC)…
- Trial name
- NCT05633654
- Testing
- Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine
- Where
- 376 sites in United States, Australia and 10 more
- Volunteers
- 1,514 people
- Sponsor
- Gilead Sciences
Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC)
A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of [68Ga]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC)…
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Urothelial Carcinoma (UC)
- Trial name
- NCT05706129
- Testing
- [68Ga]Ga-DPI-4452, [177Lu]Lu-DPI-4452
- Where
- 10 sites in Australia, France
- Volunteers
- 270 people
- Sponsor
- Lumara Bio Oncologics GmbH
Breast Cancer
Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters
RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.
- Trial name
- NCT00445562
- Testing
- biologic sample preservation procedure, informational intervention
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- GenBasix Incorporated
Neoplasms, Breast
Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer
The purpose of this study is to evaluate the safety, immunogenicity and clinical activity of a new WT1 anti-cancer immunotherapy in patients with WT1-positive Stage II or III breast cancer.
- Trial name
- INDUCT (NCT01220128)
- Testing
- GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A, Aromatase inhibitor, 5-Fluorouracil
- Where
- 36 sites in United States, Belgium and 5 more
- Volunteers
- 66 people
- Sponsor
- GlaxoSmithKline
Bladder Carcinoma, Ureter Carcinoma
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors.
- Conditions
- Bladder Carcinoma, Ureter Carcinoma, Renal Pelvis Carcinoma, Non-small Cell Lung Cancer
- Trial name
- ORACLE (NCT05059444)
- Testing
- Guardant Reveal
- Where
- 57 sites in United States, France and 3 more
- Volunteers
- 2,285 people
- Sponsor
- Guardant Health, Inc.
Colorectal Cancer, Epithelial Ovarian Cancer
[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of [68Ga]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC)…
- Conditions
- Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer (GC), Pancreatic Ductal Adenocarcinoma (PDAC)
- Trial name
- NCT07702292
- Testing
- [68Ga]BED003
- Where
- 6 sites in Italy, Netherlands
- Volunteers
- 71 people
- Sponsor
- Blue Earth Diagnostics
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.
Female Breast Carcinoma, Female Ductal Carcinoma In Situ
A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS.
- Trial name
- 007 (NCT02540330)
- Testing
- Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Atossa Therapeutics, Inc.
Colorectal Cancer, Epithelial Ovarian Cancer
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in detecting colorectal cancer (CRC), gastric cancer…
- Conditions
- Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer, Invasive Lobular Breast Carcinoma
- Trial name
- NCT07432633
- Testing
- [18F]FPyQCP
- Where
- 2 sites in United States
- Volunteers
- 71 people
- Sponsor
- Blue Earth Diagnostics
HER2-positive Breast Cancer, Breast Cancer
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
- Trial name
- EmpowHER 208 (NCT07102381)
- Testing
- Zanidatamab, Paclitaxel, Docetaxel
- Where
- 53 sites in United States, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Jazz Pharmaceuticals