Clinical trials: HER2-negative Metastatic Breast Cancer
HER2-Negative Breast Cancer
Study of Pembrolizumab in Metastatic HER2-negative Breast Cancer Patients With APOBEC3B Mutation
This is an open label investigator initiated Phase II study of single agent pembrolizumab (Keytruda) in metastatic HER2-receptive negative breast cancer patients with germline deletion in the cytosine deaminase (APOBEC3B) gene.
- Trial name
- NCT03989089
- Testing
- Pembrolizumab
- Where
- 2 sites in Malaysia, Singapore
- Volunteers
- 44 people
- Sponsor
- University of Malaya
Breast Cancer
Study of SKB103 in HER2-negative Breast Cancer
This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer.
- Trial name
- NCT07774624
- Testing
- SKB103 monotherapy
- Volunteers
- 140 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer
This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body.
- Conditions
- Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03477396
- Testing
- Aromatase Inhibitor, Laboratory Biomarker Analysis, Pharmacokinetic Study
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- City of Hope Medical Center
Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients
In the second-line treatment setting for MBC, many agents, including antitubulin drugs (Taxanes, Vinorelbine) and antimetabolites (Capecitabine, Gemcitabine), have demonstrated activity, but no agent is clearly superior.
- Trial name
- GIM11-BERGI (NCT02175446)
- Testing
- Bevacizumab and eribulin
- Where
- 17 sites in Italy
- Volunteers
- 61 people
- Sponsor
- Consorzio Oncotech
Breast Neoplasms
Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer
This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer.
- Trial name
- NCT02776917
- Testing
- Cirmtuzumab + Paclitaxel
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Barbara Parker, MD
Metastatic Breast Cancer
Nivolumab and Eribulin in HER2 Negative Metastatic Breast Cancer
Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to…
- Trial name
- KORNELIA (NCT04061863)
- Testing
- Nivolumab
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Seoul National University Hospital
Breast Neoplasms
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced…
- Trial name
- NCT02297438
- Testing
- Palbociclib, Letrozole
- Where
- 54 sites in China, Hong Kong and 3 more
- Volunteers
- 340 people
- Sponsor
- Pfizer
Breast Cancer
Bevacizumab and Abraxane as Second-line Therapy in Triple Negative Metastatic Breast Cancer
The purpose of this study is to determine whether the addition of bevacizumab to Abraxane as second-line therapy in Her-2 negative, hormone receptor negative metastatic breast cancer.
- Trial name
- NCT00472693
- Testing
- Bevacizumab, Abraxane
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive…
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
- Trial name
- SUMIT-BC (NCT05963984)
- Testing
- Samuraciclib, Fulvestrant
- Where
- 32 sites in United States, Hungary and 3 more
- Volunteers
- 60 people
- Sponsor
- Carrick Therapeutics Limited
Triple Negative Breast Cancer, HER2-negative Breast Cancer
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
- Conditions
- Triple Negative Breast Cancer, HER2-negative Breast Cancer, Non Small Cell Lung Cancer, Cervical Cancer
- Trial name
- NCT06999187
- Testing
- DR-0202
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Dren Bio
Breast Cancer
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and…
- Trial name
- COMPASS-TNBC (NCT06508216)
- Testing
- Dato-DXd, Durvalumab
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from…
- Trial name
- NCT00095862
- Testing
- allogeneic GM-CSF-secreting breast cancer vaccine, recombinant interferon alfa, cyclophosphamide
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Wiseman Research Initiatives LLC
Triple-Negative Breast Cancer
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
This is an open-label, single-arm phase II trial of first-line treatment with trastuzumab deruxtecan (T-DXd) for patients with locally advanced or metastatic triple-negative breast cancer, luminal androgen receptor subtype…
- Trial name
- NCT05953168
- Testing
- Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 69 people
- Sponsor
- Fudan University
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
MEtronomic TrEatment Option in Advanced bReast cAncer
This is a multi-center, randomized phase II trial that will randomise women with ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally relapsed breast cancer in a ratio of 1:1 to…
- Trial name
- METEORA-II (NCT02954055)
- Testing
- Paclitaxel, Cyclophosphamide, Capecitabine
- Where
- 20 sites in Italy
- Volunteers
- 140 people
- Sponsor
- ETOP IBCSG Partners Foundation
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with…
- Trial name
- NCT04546009
- Testing
- Giredestrant, Letrozole, Palbociclib
- Where
- 255 sites in United States, Argentina and 28 more
- Volunteers
- 992 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, Locally Advanced Breast Cancer
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
- Trial name
- NCT00623233
- Testing
- Gemcitabine, Bevacizumab
- Where
- 16 sites in United States
- Volunteers
- 52 people
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumors, Hematologic Neoplasms
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with…
- Conditions
- Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer, HER2-positive Advanced Solid Tumors
- Trial name
- NCT03219268
- Testing
- tebotelimab 1 mg, tebotelimab 3 mg, tebotelimab 10 mg
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 277 people
- Sponsor
- MacroGenics