Clinical trials: Her2-negative Metastatic Breast Cancer
Breast Cancer
Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic…
- Trial name
- NCT03430466
- Testing
- Durvalmab&Tremelimumab&Fulvestrant
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Kyoto Breast Cancer Research Network
Breast Cancer, Metastasis
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
- Trial name
- NCT05095207
- Testing
- Abemaciclib, Bicalutamide
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Breast Neoplasms, Breast Cancer
HER2 TREAT Study: Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable and/or Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council
HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negative patients, and previous…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Carcinoma, Genes
- Trial name
- NCT06125314
- Where
- 7 sites in Kuwait, Qatar and 2 more
- Volunteers
- 517 people
- Sponsor
- AstraZeneca
HER2-negative Breast Cancer, Recurrence
Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone…
- Conditions
- HER2-negative Breast Cancer, Recurrence, Metastasis
- Trial name
- NCT06993506
- Testing
- SKB264 Monotherapy or Combination Therapy
- Where
- 19 sites in China
- Volunteers
- 500 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Metastatic Breast Cancer
Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer
In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs.
- Trial name
- NCT00825734
- Testing
- Sorafenib, Ixabepilone
- Where
- 15 sites in United States
- Volunteers
- 83 people
- Sponsor
- SCRI Development Innovations, LLC
Advanced Solid Tumor, Metastatic Cancer
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the…
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT04464967
- Testing
- SNK01, Trastuzumab, Cetuximab
- Sponsor
- NKGen Biotech, Inc.
Breast Cancer
Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in breast cancer tumor growth, its ability to spread, and its ability to form new blood vessels.
- Trial name
- NCT01441947
- Testing
- Cabozantinib, Fulvestrant
- Where
- 4 sites in United States
- Volunteers
- 68 people
- Sponsor
- Massachusetts General Hospital
Metastatic Breast Cancer, ER-positive Breast Cancer
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05508906
- Testing
- Palazestrant, Ribociclib, Alpelisib
- Where
- 16 sites in United States, Australia
- Volunteers
- 190 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Metastatic Breast Cancer in the Liver
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease
The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with breast cancer that has spread to the liver is safe and…
- Trial name
- DELUMA (NCT06875128)
- Testing
- Melphalan/HDS followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine), Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
- Where
- 8 sites in United States, Italy and 2 more
- Volunteers
- 90 people
- Sponsor
- Delcath Systems Inc.
Metastatic Breast Cancer With HER2 Positive, Triple Negative Breast Cancer
Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain…
- Trial name
- NCT03617341
- Testing
- Brain MRI
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Yonsei University
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Cancer, Triple Negative Breast Cancer
BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
Background: Breast cancer is the second most common cause of United States (U.S.) cancer deaths in women. Immunotherapy drugs use a person's immune system to fight cancer.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, HER2+ Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- NCT04296942
- Testing
- Brachyury-TRICOM, Entinostat, M7824
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Advanced/Metastatic NSCLC, Advanced/Metastatic HER2-negative Breast Cancer
A Study Assessing Risk Factors for Oral Mucositis/Stomatitis and Ocular Surface Events in NSCLC and Breast Cancer
This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor…
- Trial name
- NCT06686602
- Testing
- No drug
- Where
- United States
- Volunteers
- 13,759 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Treatment for HR+/HER2- Metastatic Breast Cancer Patients
A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.
- Trial name
- NCT06655545
- Where
- China
- Volunteers
- 473 people
- Sponsor
- Fudan University
Advanced Solid Tumours, Endometrial Cancer
A Phase 1 Study of [225Ac]-FPI-1434 Injection
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of [225Ac]-FPI-1434 (radioimmuno-therapeutic…
- Conditions
- Advanced Solid Tumours, Endometrial Cancer, Cervical Cancer, Ovarian Cancer
- Trial name
- NCT03746431
- Testing
- [111In]-FPI-1547 Injection, [225Ac]-FPI-1434 Injection multi-dose, FPI-1175 Infusion
- Where
- 13 sites in United States, Australia and 1 more
- Volunteers
- 78 people
- Sponsor
- Fusion Pharmaceuticals Inc.
Breast Neoplasms
A Study of Famitinib Malate in HER2-negative Metastatic Breast Cancer
The hypothesis of this clinical research study is to discover if the study drug Famitinib Malate can shrink or slow the growth of pretreated HER2-negative metastatic breast cancer.
- Trial name
- NCT01653574
- Testing
- Famitinib Malate
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Fudan University
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
- Trial name
- NCT07612891
- Testing
- INV-6452
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Breast Cancer
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative…
- Trial name
- NCT06702618
- Testing
- TQB3616 capsule+Fulvestrant Injection
- Where
- 13 sites in China
- Volunteers
- 33 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.