Clinical trials: Breast Tumor Tissue
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Breast Cancer
Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients
The 105-15-201 study is designed to assess the effectiveness and tolerability of the combination of heat-activated target therapy (radiotherapy + hyperthermia + lyso-thermosensitive liposomal doxorubicin) of loco-regional relapse…
- Trial name
- EURO-DIGNITY (NCT02850419)
- Testing
- ThermoDox (Thermally Sensitive Liposomal Doxorubicin), Radiation Therapy, Superficial Hyperthermia
- Where
- 3 sites in Czechia, Israel and 1 more
- Sponsor
- Imunon
Metastatic Breast Cancer, Locally Recurrent Breast Cancer
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment…
- Trial name
- FORTRESS (NCT03786094)
- Testing
- Eribulin, Balixafortide
- Where
- 88 sites in United States, Argentina and 11 more
- Volunteers
- 432 people
- Sponsor
- Spexis AG
Metastatic Breast Cancer
Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant
The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.
- Trial name
- NCT01019577
- Testing
- Ixabepilone
- Volunteers
- 54 people
- Sponsor
- R-Pharm
Breast Cancer Female
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
- Trial name
- NCT04242277
- Testing
- Investigational WF-OCT device
- Where
- 2 sites in United States
- Volunteers
- 198 people
- Sponsor
- Perimeter Medical Imaging
Breast Cancer, Non-small Lung Cancer
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel.
- Trial name
- NCT01862081
- Testing
- Docetaxel, GDC-0032, Paclitaxel
- Where
- 14 sites in United States, Belgium and 2 more
- Volunteers
- 80 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Comparative Study of QL1209 and Perjeta® in Healthy Male Participants
The goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male…
- Trial name
- NCT07861139
- Testing
- QL1209, US-Perjeta®
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Breast Cancer
Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer
This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety…
- Trial name
- NCT00864175
- Testing
- INCB007839, trastuzumab, Docetaxel
- Where
- 12 sites in India
- Volunteers
- 68 people
- Sponsor
- Incyte Corporation
Breast Cancer
Identification and Semi-Quantification of Ki-67 Protein Expression Status
The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.
- Trial name
- NCT02654457
- Testing
- Women with Breast Cancer
- Volunteers
- 3 people
- Sponsor
- Applied Spectral Imaging Ltd.
Breast Neoplasms
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients…
- Trial name
- NCT01325428
- Testing
- Afatinib once daily (OD), Vinorelbine Weekly
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT07261631
- Testing
- 68Ga-NNS309, 177Lu-DFC413
- Where
- 9 sites in United States, Canada and 5 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Prostate Cancer
[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer…
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Non Small Cell Lung Cancer
- Trial name
- NeoFIND (NCT03724253)
- Testing
- [68Ga]-NeoBOMB1
- Where
- 3 sites in Austria, France
- Volunteers
- 19 people
- Sponsor
- Advanced Accelerator Applications
EpCam Positive Tumor (e.g.Ovarian, Gastric, Colon, Breast), Malignant Ascites
Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.
- Trial name
- NCT00836654
- Testing
- Catumaxomab (Removab), paracentesis
- Volunteers
- 258 people
- Sponsor
- Neovii Biotech
Advanced and Selected Solid Tumors
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given…
- Trial name
- NCT01155453
- Testing
- BKM120, GSK1120212
- Where
- 7 sites in United States, Belgium and 3 more
- Volunteers
- 113 people
- Sponsor
- Novartis Pharmaceuticals
Breast Tumour
Fluorescence-guided Resection in Breast Cancer
This is an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.
- Trial name
- NCT01110954
- Testing
- PD L 506
- Where
- Germany
- Volunteers
- 8 people
- Sponsor
- photonamic GmbH & Co. KG
Neoplasms, Breast Neoplasms, Head and Neck Neoplasms
A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer
Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel…
- Trial name
- NCT02051751
- Testing
- BYL719, Paclitaxel
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program
The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation…
- Trial name
- NCT02685566
- Testing
- FFDM Plus DBT, FFDM
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Radiotherapy, Immunotherapy
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.
- Conditions
- Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Liver
- Trial name
- NCT03589339
- Testing
- NBTXR3, SABR, Nivolumab
- Where
- 13 sites in United States
- Volunteers
- 145 people
- Sponsor
- Nanobiotix
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