Clinical trials: Metastatic Breast Cancer (MBC)
Recurrent or Metastatic Breast Cancer
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
- Trial name
- OPTIMAL (NCT03315364)
- Testing
- Oral paclitaxel, Paclitaxel injection
- Where
- 51 sites in Bulgaria, China and 3 more
- Volunteers
- 549 people
- Sponsor
- Daehwa Pharmaceutical Co., Ltd.
Breast Cancer, Cancer of the Breast
Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging.
- Trial name
- NCT04968964
- Testing
- DiviTum® TKa assay, Study Care Plans
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Washington University School of Medicine
Breast Neoplasms
Phase II Trial of Oxaliplatin in Combination With S-1(SOX) in Patients With Recurrent or Metastatic Breast Cancer
Phase II trial of oxaliplatin in combination with S-1(SOX) in patients with recurrent or metastatic breast cancer (MBC) previously treated with or resistant to an anthracycline and taxane
- Trial name
- TORCH (NCT00527930)
- Testing
- TS-1 and Eloxatin
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- Seoul National University Hospital
Breast Cancer
Determinants of Resistance to Endocrine Therapy and a Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor for HR+ MBC
The goal of this research study is to determine if the investigators can predict which participants will respond to endocrine therapy and a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor for metastatic breast cancer and…
- Trial name
- NCT03439735
- Testing
- Endocrine Therapy and a CDK 4/6 inhibitor
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
HER2-positive Breast Cancer
Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and…
- Trial name
- NCT06833268
- Testing
- No drug
- Where
- United States
- Volunteers
- 228 people
- Sponsor
- Daiichi Sankyo
Metastatic Breast Cancer (MBC)
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).
- Trial name
- NCT00236899
- Testing
- Gemcitabine, Docetaxel, Paclitaxel
- Where
- 34 sites in Italy
- Volunteers
- 241 people
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumors, Metastatic Breast Cancer
Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Renal Cell Carcinoma
- Trial name
- NCT01482156
- Testing
- RAD001 + BEZ235
- Where
- 10 sites in United States, Belgium and 5 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Metastatic
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy…
- Trial name
- ABIGAIL (NCT04603183)
- Testing
- Abemaciclib, Paclitaxel, Letrozole
- Where
- 31 sites in Italy, Portugal and 1 more
- Volunteers
- 162 people
- Sponsor
- MedSIR
Advanced Breast Cancer, Breast Cancer
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer.
- Conditions
- Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT00387907
- Testing
- larotaxel (XRP9881), trastuzumab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sanofi
Survivorship
LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training
In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills…
- Trial name
- NCT07539649
- Testing
- LiveWell mBC: A Group-Based Adapted Dialectical Behavioral Therapy Skills Training Program
- Volunteers
- 48 people
- Sponsor
- Medical University of South Carolina
Cancer
Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
It will be conducted as an international multicenter prospective observational cohort study in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen…
- Trial name
- TYCO (NCT01160094)
- Testing
- Treatment
- Where
- 10 sites in Colombia, Saudi Arabia
- Volunteers
- 288 people
- Sponsor
- Novartis
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
The goal of this national, multicenter single arm phase II clinical trial is to study the efficacy, safety and tolerability of the administration of Trastuzumab Deruxtecan (T-DXd) in HER2-positive locally advanced or metastatic…
- Trial name
- TRANSCENDER (NCT05744375)
- Testing
- Trastuzumab deruxtecan
- Where
- 19 sites in Spain
- Volunteers
- 2 people
- Sponsor
- Spanish Breast Cancer Research Group
Everolimus, Pneumonitis
Everolimus Related Pneumonitis in MBC
To study the drug-related pneumonitis during mTOR inhibitor therapy in patients with metastatic breast cancer.
- Trial name
- NCT03730428
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Fudan University
Breast Cancer, Advanced Breast Cancer
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the use of lovastatin, a cholesterol-depleting pro-drug that may lower CAV-1 levels, in order to increase HER2 expression on the cell surface of cancer cells and enhance the uptake and…
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT07619365
- Testing
- Trastuzumab deruxtecan, Lovastatin
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Washington University School of Medicine
Estrogen Receptor Negative, Estrogen Receptor Positive
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT03213041
- Testing
- Carboplatin, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Northwestern University
Breast Cancer
Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line
The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined.
- Trial name
- NCT00191854
- Testing
- gemcitabine, paclitaxel, carboplatin
- Where
- 18 sites in Brazil, China and 4 more
- Volunteers
- 147 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous…
- Trial name
- NCT00928330
- Testing
- GDC-0941, Trastuzumab, trastuzumab-MCC-DM1
- Where
- 3 sites in United States
- Volunteers
- 57 people
- Sponsor
- Genentech, Inc.
Breast Cancer
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based…
- Trial name
- NCT04460898
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- Pfizer
Breast Cancer
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body…
- Trial name
- PETRA (NCT01805908)
- Testing
- 111In-Pertuzumab + SPECT-CT
- Where
- 2 sites in Canada
- Volunteers
- 3 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
Malignant Neoplasm of Breast
Swedish Ibrance Registries Insights (SIRI)
The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.
- Trial name
- SIRI (NCT04654208)
- Testing
- palbociclib
- Where
- Sweden
- Volunteers
- 1,500 people
- Sponsor
- Pfizer