Clinical trials: HER2-negative Metastatic Breast Cancer
Metastatic Breast Cancer
Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.
- Trial name
- NCT00958971
- Testing
- TKI258
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive
- Trial name
- NCT03723928
- Testing
- Usual care disease monitoring, Serum Tumor Marker directed disease monitoring, Quality-of-Life Assessment
- Where
- 723 sites in United States, Guam and 1 more
- Volunteers
- 739 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Adult Solid Neoplasm, Estrogen Receptor Negative
Weekly Doses of Cilengitide and Paclitaxel in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery
This phase I trial studies the side effects and the best dose of cilengitide when given together with paclitaxel weekly in treating patients with solid tumors that have spread nearby or to other areas of the body and cannot be…
- Conditions
- Adult Solid Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Male Breast Carcinoma
- Trial name
- NCT01276496
- Testing
- Cilengitide, Laboratory Biomarker Analysis, Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- National Cancer Institute (NCI)
Locally Recurrent and Metastatic Breast Cancer
Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment…
- Trial name
- NCT00511459
- Testing
- AMG 386, Bevacizumab, Paclitaxel
- Where
- 77 sites in United States, Australia and 11 more
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Amgen
HER2 Negative Metastatic Breast Cancer
Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer
90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression…
- Trial name
- CONCEPT (NCT03048942)
- Testing
- Cabazitaxel, Paclitaxel
- Where
- 13 sites in United Kingdom
- Volunteers
- 158 people
- Sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
HER2-negative
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal growth factor receptor 2…
- Trial name
- iRetroBC (NCT06131424)
- Where
- 31 sites in Argentina, Brazil and 11 more
- Volunteers
- 1,151 people
- Sponsor
- AstraZeneca
Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.
- Trial name
- NCT01446159
- Testing
- MEDI-573, Aromatase Inhibitor
- Where
- 71 sites in United States, Belgium and 9 more
- Volunteers
- 188 people
- Sponsor
- MedImmune LLC
Metastatic Breast Cancer, HER2 Low Breast Carcinoma
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast…
- Conditions
- Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- ERADICATE (NCT07198724)
- Testing
- Elacestrant, Trastuzumab Deruxtecan
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Kristina A. Fanucci
Metastatic Invasive Breast Cancer, Resistant Breast Cancer
Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer
The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2/3/4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+/HER2-negative breast cancer.
- Conditions
- Metastatic Invasive Breast Cancer, Resistant Breast Cancer, ER+, HER2-, Metastatic Breast Cancer
- Trial name
- NCT07729046
- Testing
- Neratinib + endocrine therapy, Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, CDK4/6 + Endocrine therapy
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of California, San Diego
Breast Cancer
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.).
- Trial name
- NCT05266105
- Testing
- Palazestrant, Palbociclib
- Where
- 8 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Cancer
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor…
- Trial name
- NCT05950945
- Testing
- Trastuzumab Deruxtecan
- Where
- 88 sites in United States, Australia and 8 more
- Volunteers
- 250 people
- Sponsor
- Daiichi Sankyo
Invasive Breast Cancer, Metastatic Breast Cancer
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer.
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT04448886
- Testing
- Pembrolizumab, Sacituzumab Govitecan
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Ana C Garrido-Castro, MD
Breast Cancer
Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or…
- Trial name
- NCT01234337
- Testing
- Sorafenib (Nexavar, BAY43-9006), Capecitabine
- Where
- 153 sites in United States, Argentina and 21 more
- Volunteers
- 537 people
- Sponsor
- Bayer
Breast Cancer, Metastatic Cancer
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05205200
- Testing
- SHR-1316, SHR6390, Nab paclitaxel
- Where
- China
- Volunteers
- 338 people
- Sponsor
- Fudan University
Estrogen Receptor Negative Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K inhibitor GDC-0941 when given with the chemotherapy cisplatin.
- Conditions
- Estrogen Receptor Negative Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Triple Negative Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT01918306
- Testing
- cisplatin, laboratory biomarker analysis, pharmacological study
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Breast Cancer Metastatic
Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.
- Trial name
- NCT03086785
- Testing
- Apatinib
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer
Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer
Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane.
- Trial name
- NCT01662128
- Testing
- Xeloda
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Tianjin Medical University
Breast Cancer
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
- Trial name
- NCT07062965
- Testing
- PF-07248144, Fulvestrant, Everolimus
- Where
- 433 sites in United States, Argentina and 29 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics