Clinical trials: Her2-negative Metastatic Breast Cancer
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)
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
Metastatic Triple Negative Breast Cancer
Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer
This study will evaluate the effectiveness and safety of the combination of two drugs, Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer that have undergone previous treatment.
- Trial name
- NCT02158507
- Testing
- Combination of Veliparib + Lapatinib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Breast Neoplasm, Brain Metastases
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre.
- Conditions
- Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Trial name
- SYMPToM (NCT03881605)
- Testing
- MRI screening
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Sunnybrook Health Sciences Centre
HR Positive HER2 Negative Advanced Breast Cancer
Iribrine Plus Tucidinostat in the Treatment of HR+/HER2 Advanced Breast Cancer After CDK4/6 Inhibitor Failure
To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer
- Trial name
- NCT05335473
- Testing
- Eribulin and Tucidinostat
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Henan Cancer Hospital
Metastatic Breast Cancer
Observation of Medical Treatments in MBC HER2-negative Patients
While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors.
- Trial name
- AMBRA (NCT02365831)
- Testing
- Observation of treatment management
- Where
- Italy
- Volunteers
- 1,500 people
- Sponsor
- Consorzio Oncotech
Metastatic Breast Cancer
Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial
This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast…
- Trial name
- NCT06308939
- Testing
- Eribulin, Sintilimab
- Where
- China
- Volunteers
- 81 people
- Sponsor
- Zhejiang Cancer Hospital
Metastatic Breast Cancer (MBC)
Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer
This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous…
- Trial name
- NCT06143553
- Testing
- Paclitaxel Polymeric Micelles for Injection, Eribulin Mesilate injection, Capecitabine Tablets
- Where
- 3 sites in China
- Volunteers
- 168 people
- Sponsor
- Shanghai Yizhong Pharmaceutical Co., Ltd.
Breast Cancer
Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
- Trial name
- NCT03393845
- Testing
- Pembrolizumab, Fulvestrant
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- Nancy Chan, MD
Breast Cancer
Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
This trial was designed to evaluate the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) in subjects with TQB3912 tablets combined with fulvestrant injection and TQB3616 capsules for locally advanced or…
- Trial name
- NCT06851442
- Testing
- TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules
- Where
- 17 sites in China
- Volunteers
- 8 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
Breast Cancer
Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or…
- Trial name
- NCT06344780
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Fudan University
Breast Cancer
A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)
This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer.
- Trial name
- NCT01156961
- Testing
- bevacizumab [Avastin], paclitaxel
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.
- Trial name
- NCT00517361
- Testing
- carboplatin, bevacizumab
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Chicago
Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma
Effects of Ribociclib and Palbociclib on Tumor and Blood Characteristics in Patients With Metastatic Breast Cancer
This clinical trial attempts to understand the differences between two chemotherapy drugs, ribociclib and palbociclib, and how they fight cancer.
- Conditions
- Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Trial name
- NCT05244434
- Testing
- Best Practice, Biopsy, Biospecimen Collection
- Sponsor
- City of Hope Medical Center
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 gpNMB Over-expressing Triple Negative Breast Cancer
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a…
- Trial name
- METRIC (NCT01997333)
- Testing
- CDX-011, Capecitabine
- Where
- 140 sites in United States, Australia and 7 more
- Volunteers
- 327 people
- Sponsor
- Celldex Therapeutics
Breast Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive…
- Trial name
- optINAVO (NCT07368998)
- Testing
- Inavolisib, Fulvestrant
- Where
- 34 sites in United States, Argentina and 6 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Axillary Nodal Burden in HER2+ and TNBC
This study aimed to evaluated rates of pathologic axillary nodal metastasis in patients with with early-stage HER2-positive BC or TNBC who had clinically node-negative status on preoperative ultrasonography and underwent upfront…
- Trial name
- NCT07211451
- Testing
- Breast conserving surgery with axillary surgery
- Where
- South Korea
- Volunteers
- 1,571 people
- Sponsor
- Gangnam Severance Hospital
Metastatic Breast Cancer
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase…
- Trial name
- NCT02753595
- Testing
- Eribulin mesylate, Biologic: PEGylated recombinant human hyaluronidase (PEGPH20), Biologic: PEGylated recombinant human hyaluronidase
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Eisai Inc.