Clinical trials: HER2 Positive Metastatic Breast Cancer
Breast Neoplasms, Malignant Neoplasm of Breast
Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer
This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with…
- Trial name
- NCT03379428
- Testing
- Trastuzumab, Ibrutinib 560 mg, Ibrutinib 840 mg
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- US Oncology Research
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 Positive Metastatic Breast Cancers
A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine…
- Trial name
- NCT02025192
- Testing
- Tucatinib, Capecitabine, Trastuzumab
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Seagen Inc.
Metastatic Breast Cancer
Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies
Recent clinical studies have shown that the combination of lapatinib and trastuzumab has superior antitumor activity compared to either single drug in both neoadjuvant and metastatic setting and is well tolerated.
- Trial name
- NCT02238509
- Testing
- Lapatinib, Trastuzumab
- Where
- 36 sites in Italy
- Volunteers
- 154 people
- Sponsor
- Consorzio Oncotech
Estrogen Receptor Positive, HER2 Positive Breast Carcinoma
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone…
- Conditions
- Estrogen Receptor Positive, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Progesterone Receptor Positive
- Trial name
- NCT00390455
- Testing
- Fulvestrant, Laboratory Biomarker Analysis, Lapatinib Ditosylate
- Where
- 368 sites in United States
- Volunteers
- 295 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Breast Cancer, Metastatic Breast Cancer
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer.
- Trial name
- NCT04924699
- Testing
- MRG002, Trastuzumab Emtansine for Injection
- Where
- 19 sites in China
- Volunteers
- 350 people
- Sponsor
- Shanghai Miracogen Inc.
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative…
- Trial name
- CAPItello-292 (NCT04862663)
- Testing
- Capivasertib, Fulvestrant, Palbociclib
- Where
- 225 sites in United States, Argentina and 21 more
- Volunteers
- 893 people
- Sponsor
- AstraZeneca
HER2-positive Metastatic Breast Cancer
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.
- Trial name
- NCT06551116
- Testing
- CE-10-IVD
- Where
- 37 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
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
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- ELEMENT (NCT06201234)
- Testing
- Olaparib + Elacestrant, Olaparib
- Where
- 36 sites in Germany
- Volunteers
- 176 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer
Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status
The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB] and a non anthracycline-based regimen…
- Trial name
- NeoTOP (NCT02339532)
- Testing
- FEC100, Docetaxel, Trastuzumab
- Where
- 12 sites in France
- Volunteers
- 86 people
- Sponsor
- UNICANCER
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
Unresectable or Metastatic Breast Cancer
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion.
- Trial name
- NCT06167694
- Testing
- HRS-8080; Dalpiciclib Isethionate Tablets
- Where
- 2 sites in China
- Volunteers
- 146 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
Breast Cancer
Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00238290
- Testing
- Trastuzumab + Letrozole
- Where
- 14 sites in Switzerland
- Volunteers
- 13 people
- Sponsor
- Swiss Cancer Institute
Carcinoma, Ductal, Breast, Breast Cancer Female
G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer
This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in…
- Conditions
- Carcinoma, Ductal, Breast, Breast Cancer Female, Breast Neoplasm, Breast Cancer
- Trial name
- NCT03455270
- Testing
- G1T48, Palbociclib
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 107 people
- Sponsor
- G1 Therapeutics, Inc.
BRMS1, Performance Status Zero to Two for Beginning the Study
Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment.
Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation…
- Conditions
- BRMS1, Performance Status Zero to Two for Beginning the Study, Patient With a Maximum of One Chemotherapy, Patient With Progression After Taxanes
- Trial name
- GLICO-0801 (NCT01050322)
- Testing
- Lapatinib Vinorelbine, Lapatinib Capecitabine, Gemcitabine Lapatinib
- Where
- 18 sites in Argentina, Brazil and 1 more
- Volunteers
- 142 people
- Sponsor
- Latin American Cooperative Oncology Group
Breast Cancer, Pyrotinib
Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or…
- Conditions
- Breast Cancer, Pyrotinib, Breast Diseases, Vinorelbine
- Trial name
- NCT04605575
- Testing
- Pyrotinib 320mg + Vinorelbine, Pyrotinib 400mg + Vinorelbine, Pyrotinib plus Vinorelbine
- Where
- China
- Volunteers
- 208 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of T-DM1 in metastatic/relapsed HER2-positive breast cancer as part of the establishment of hospital medical…
- Trial name
- NCT04202328
- Where
- 60 sites in South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.