Clinical trials: Disorders of Breast
Breast Cancer
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with…
- Trial name
- EMILIA (NCT00829166)
- Testing
- Trastuzumab emtansine, Lapatinib, Capecitabine
- Where
- 323 sites in United States, Bosnia and Herzegovina and 25 more
- Volunteers
- 991 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Ultrasonography
Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Mammography, Including Cost Comparisons
The purpose of this study is to determine whether addition of automated whole breast ultrasound to the usual screening mammography in a population of asymptomatic women with mammographically dense breasts will result in a…
- Trial name
- NCT00649337
- Testing
- Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography
- Where
- United States
- Volunteers
- 4,650 people, healthy volunteers welcome
- Sponsor
- SonoCine, Inc.
Breast Neoplasms
Study Evaluating HKI-272 in Tumors
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272.
- Trial name
- NCT00146172
- Testing
- neratinib
- Where
- 5 sites in United States
- Volunteers
- 73 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer, Metastasis
Study of GPX-100 in the Treatment of Metastatic Breast Cancer
The purpose of this early Phase II multicenter trial is to determine the objective clinical response to GPX-100, an anthracycline similar to doxorubicin, in up to 40 patients with newly diagnosed metastatic breast cancer.
- Trial name
- NCT00123877
- Testing
- GPX-100 (13-deoxydoxorubicin)
- Where
- 3 sites in United States, Bulgaria
- Volunteers
- 40 people
- Sponsor
- Gem Pharmaceuticals
Breast Cancer
Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging.
- Trial name
- NCT02155075
- Testing
- MIRA device imaging
- Where
- Israel
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Real Imaging Ltd.
Metastatic Breast Cancer
Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens
The purpose of this study is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), in HER2-overexpressed recurrent stage IV breast cancer patients who received at least 2 prior HER2-directed…
- Trial name
- NCT02418689
- Testing
- NOV120101 (Poziotinib)
- Where
- 7 sites in South Korea
- Volunteers
- 106 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Breast Cancer
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer.
- Trial name
- NCT02005549
- Testing
- bevacizumab [Avastin], docetaxel, capecitabine [Xeloda]
- Where
- Austria
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Computed Tomography Laser Mammography Breast Imaging Device
The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.
- Trial name
- CTLM (NCT00589043)
- Volunteers
- 600 people
- Sponsor
- Imaging Diagnostic Systems
Triple-negative Breast Cancer
A Study of KN046 in Subjects With Locally Advanced or Metastatic Triple-negative Breast Cancer
This is an open-label, phase Ib/II, multi-center study to evaluate efficacy and safety of KN046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic triple negative breast…
- Trial name
- NCT03872791
- Testing
- KN046, Nab-paclitaxel
- Where
- 12 sites in China
- Volunteers
- 52 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Breast Cancer
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy…
- Trial name
- NCT06086340
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 779 people
- Sponsor
- Pfizer
Breast Cancer
Study of SKB103 in HER2-negative Breast Cancer
This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer.
- Trial name
- NCT07774624
- Testing
- SKB103 monotherapy
- Volunteers
- 140 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Cancer, Breast Cancer Metastatic
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers.
- Conditions
- Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- INX-315-01 (NCT05735080)
- Testing
- INX-315, Fulvestrant, Abemaciclib
- Where
- 18 sites in United States, Australia
- Volunteers
- 150 people
- Sponsor
- Incyclix Bio
Breast Neoplasms
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
The primary objective is to evaluate whether treatment with alpelisib in combination with fulvestrant prolongs Progression Free Survival (PFS) compared to treatment with placebo in combination with fulvestrant.
- Trial name
- NCT04544189
- Testing
- Alpelisib, Fulvestrant
- Where
- 24 sites in China
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Invasive Breast Cancer
Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients
This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.
- Conditions
- Breast Cancer, Invasive Breast Cancer, Metastatic Breast Cancer, Breast Carcinoma
- Trial name
- FIONA (NCT04262518)
- Testing
- Outcomes4Me Mobile App
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Outcomes4Me
Gynecomastia
Gynecomastia Extension Study
The purpose of this study is to look at the effect of anastrozole (ZD1033, Arimidex™) in reducing gynecomastia in pubertal boys treated with placebo in Trial 1033US/0006 (another anastrozole study).
- Trial name
- NCT00637182
- Testing
- Anastrozole
- Sponsor
- AstraZeneca
Neoplasms
A Study Of PF-06664178 In Patients With Advanced Solid Tumors
To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
- Trial name
- NCT02122146
- Testing
- PF-06664178
- Where
- 10 sites in United States
- Volunteers
- 31 people
- Sponsor
- Pfizer
Breast Cancer
CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs.
- Trial name
- CARIATIDE (NCT00681122)
- Where
- 164 sites in Australia, Austria and 16 more
- Volunteers
- 2,600 people
- Sponsor
- AstraZeneca
Breast Cancer
MarginProbe 2.0 Data Collection Protocol
Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen.
- Trial name
- NCT05377229
- Testing
- MarginProbe2.0
- Where
- 9 sites in United States, Israel
- Volunteers
- 398 people
- Sponsor
- Dilon Medical Technologies Ltd.
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
HER-2 Positive Breast Cancer, Metastatic Breast Cancer
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel.
- Trial name
- NCT00788931
- Testing
- IV LBH589, Oral LBH589, trastuzumab
- Where
- 7 sites in United States, Australia and 3 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
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