Clinical trials: Metastatic Breast Carcinoma
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer
Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.
- Trial name
- NCT05021900
- Testing
- Tenalisib 800mg, Tenalisib 1200mg
- Where
- 3 sites in Georgia
- Volunteers
- 40 people
- Sponsor
- Rhizen Pharmaceuticals SA
Endocrine/Neuroendocrine, Non-Small Cell Lung Cancer
Non-Viral TCR Gene Therapy
Background: A person s white blood cells can be modified in a lab to recognize certain changes in their tumor. Many of these cells are collected from the person, modified, then given back to the person.
- Conditions
- Endocrine/Neuroendocrine, Non-Small Cell Lung Cancer, Breast Cancer, Gastrointestinal/Genitourinary Cancers
- Trial name
- NCT04102436
- Testing
- Fludarabine, Cyclophosphamide, Aldesleukin
- Where
- United States
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across ~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients.
- Trial name
- SPEAR (NCT05022342)
- Testing
- alpelisib plus fulvestrant
- Where
- 28 sites in India
- Volunteers
- 595 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and…
- Trial name
- ELENI (NCT07563595)
- Testing
- Elacestrant, Standard of care (Investigator Choice)
- Where
- 3 sites in Germany
- Volunteers
- 500 people
- Sponsor
- iOMEDICO AG
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Tka Assay for CDK4/6i
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize…
- Trial name
- NCT06572800
- Testing
- DiviTum-TKa
- Where
- 18 sites in United States
- Volunteers
- 34 people
- Sponsor
- Yale University
Breast Cancer
BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis.
- Trial name
- BREAST-10 (NCT00540800)
- Testing
- docetaxel, epirubicin, capecitabine
- Where
- 3 sites in Italy
- Volunteers
- 139 people
- Sponsor
- National Cancer Institute, Naples
HR+/HER2- Breast Cancer, Metastatic Disease
Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.
The ATLANT study is prospective, multicentre, non-interventional, observational study. Patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy.
- Conditions
- HR+/HER2- Breast Cancer, Metastatic Disease, Аdvanced Disease
- Trial name
- ATLANT (NCT05789771)
- Testing
- Abemaciclib
- Where
- Russia
- Volunteers
- 136 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Breast Neoplasms, Neoplasm Metastasis
Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how…
- Trial name
- NCT00067314
- Testing
- Edotecarin
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 65 people
- Sponsor
- Pfizer
Breast Cancer
Capecitabine (XELODA) With Or Without Lapatinib (GW572016) For Women With Refractory Advanced or Metastatic Breast Cancer
This study was designed to compare the efficacy and safety of an oral dual tyrosine kinase inhibitor in combination with capecitabine versus capecitabine alone in women with locally advanced or metastatic breast cancer that has…
- Trial name
- NCT00078572
- Testing
- capecitabine, lapatinib (GW572016)
- Volunteers
- 408 people
- Sponsor
- GlaxoSmithKline
Breast Cancer
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer.
- Trial name
- HERODOT (NCT01187381)
- Testing
- Trastuzumab
- Where
- Romania
- Volunteers
- 250 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Triple Negative Breast Cancer(TNBC)
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally…
- Trial name
- NCT06419621
- Testing
- PM8002, Nab-Paclitaxel
- Where
- 70 sites in China
- Volunteers
- 392 people
- Sponsor
- Biotheus Inc.
Breast Cancer, Leptomeningeal Metastasis
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.
This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis.
- Trial name
- NCT03974204
- Testing
- Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment, Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification, Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment
- Where
- 2 sites in France
- Sponsor
- Centre Oscar Lambret
Metastatic Breast Cancer
A Phase I Cancer Vaccine Study for Patients With Metastatic Breast Cancer
The study uses a molecule or particle that is found only on cancer cells and is unique to cancer cells, as it is not detected on normal tissue. The molecule is known as "oncofetal antigen" or OFA.
- Trial name
- NCT00715832
- Testing
- Dendritic Cell Vaccination
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Southern Cancer Center
Breast Cancer
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with…
- Trial name
- NCT00788333
- Testing
- BMS-754807, trastuzumab (Herceptin®)
- Where
- 9 sites in Australia, Belgium and 3 more
- Volunteers
- 40 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer
PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative…
- Trial name
- PELICAN (NCT03841747)
- Testing
- Pembrolizumab, Paclitaxel
- Sponsor
- Queen Mary University of London
Breast Cancer
Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
This is a phase l/II study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses to find out what effects, if any, it…
- Trial name
- NCT03377387
- Testing
- Capecitabine, Neratinib, EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.
The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in…
- Trial name
- REPARP (NCT05378204)
- Testing
- Main study:, Sub-study:
- Where
- 25 sites in France
- Volunteers
- 120 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer, Metastatic Breast Cancer
89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study
The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer, Gastric Cancer
- Trial name
- HER Image (NCT05955833)
- Testing
- 89Zr-DFO*-trastuzumab PET scan
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Amsterdam UMC, location VUmc
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