Clinical trials: HER2-positive Recurrent / Metastatic Breast Cancer
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma
Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer
This phase II trial studies capecitabine and lapatinib ditosylate to see how well they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating patients with previously treated HER2-positive stage…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
- Trial name
- NCT00684983
- Testing
- Capecitabine, Cixutumumab, Lapatinib Ditosylate
- Where
- 390 sites in United States
- Volunteers
- 64 people
- Sponsor
- National Cancer Institute (NCI)
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Brain and Central Nervous System Tumors, Breast Cancer
BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain
RATIONALE: Osmotic blood-brain barrier disruption uses certain drugs, such as mannitol, to open the blood vessels around the brain and allow tumor-killing substances to be carried directly to the brain.
- Conditions
- Brain and Central Nervous System Tumors, Breast Cancer, Cognitive/Functional Effects, Drug/Agent Toxicity by Tissue/Organ
- Trial name
- NCT00397501
- Testing
- trastuzumab, carboplatin, methotrexate
- Sponsor
- OHSU Knight Cancer Institute
Breast Cancer
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented…
- Trial name
- NCT00667251
- Testing
- trastuzumab, docetaxel, lapatinib ditosylate
- Where
- 257 sites in United States, Argentina and 19 more
- Volunteers
- 652 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/Neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00068757
- Testing
- trastuzumab, lonafarnib, paclitaxel
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 23 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Recurrent or Metastatic Breast Cancer
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first…
- Trial name
- NCT07406542
- Testing
- SYS6010, Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Adult Solid Neoplasm, Estrogen Receptor Negative
Veliparib in Combination With Carboplatin and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors
This phase I clinical trial studies the side effects and the best dose of veliparib when given together with carboplatin and paclitaxel in treating patients with locally advanced or metastatic solid tumors.
- Conditions
- Adult Solid Neoplasm, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT01281150
- Testing
- Carboplatin, Laboratory Biomarker Analysis, Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- National Cancer Institute (NCI)
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer.
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer
- Trial name
- NCT01791478
- Testing
- PI3K inhibitor BYL719, letrozole, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic…
- Conditions
- Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01217411
- Testing
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
Triple Negative Breast Cancer, Locally Advanced Breast Cancer
PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.
- Conditions
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer, Metastatic Breast Cancer
- Trial name
- PAveMenT (NCT04360941)
- Testing
- Palbociclib, Avelumab
- Where
- 9 sites in United Kingdom
- Volunteers
- 45 people
- Sponsor
- Royal Marsden NHS Foundation Trust
HER2-positive Breast Cancer, Breast Cancer
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Breast Cancer, Breast Cancer Stage, Recurrent Breast Cancer
- Trial name
- T-DM1 (NCT03530696)
- Testing
- Palbociclib, T-DM1
- Where
- 16 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Arizona
First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the…
- Trial name
- NCT05838066
- Testing
- Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801, Pertuzumab
- Where
- China
- Volunteers
- 880 people
- Sponsor
- Shanghai JMT-Bio Inc.
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Clinical Stage III Gastric Cancer AJCC v8
- Trial name
- NCT04550494
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior…
- Trial name
- NCT00391092
- Testing
- bevacizumab [Avastin], Docetaxel, Herceptin
- Where
- 89 sites in Argentina, Australia and 14 more
- Volunteers
- 424 people
- Sponsor
- Hoffmann-La Roche
Immunotherapy, Chemotherapy
Clinical Study of Chemotherapy and Immunotherapy Combined With Lactobacillus Johnsonii in Patients With Multiple Irresectable Solid Tumors
This study plans to enroll 156 patients aged 18-75, who will be randomly divided into two groups to evaluate the clinical efficacy and safety of chemotherapy and immune therapy combined with Lactobacillus johnsonii in patients…
- Trial name
- NCT07191405
- Testing
- oral Lactobacillus johnsonii (1×10¹¹ CFU, twice daily)
- Volunteers
- 156 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Metastatic Breast Cancer
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
- Trial name
- NCT04367090
- Testing
- Docetaxel, trastuzumab, Pyrotinib
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant.
- Trial name
- NCT03481998
- Testing
- SHR6390, Letrozole or anastrozole or Fulvestrant
- Where
- 4 sites in China
- Volunteers
- 104 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus…
- Trial name
- NCT01120184
- Testing
- docetaxel, paclitaxel, pertuzumab
- Where
- 257 sites in United States, Argentina and 36 more
- Volunteers
- 1,095 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, Male Breast Cancer
Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer
This randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human…
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT01355393
- Testing
- HER-2/neu peptide vaccine, sargramostim, rintatolimod
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Washington
HER2/Neu Positive, Recurrent Breast Carcinoma
Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy
This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2)…
- Conditions
- HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IV Breast Cancer
- Trial name
- NCT01922921
- Testing
- HER-2/neu Intracellular Domain Protein, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington