Clinical trials: HER2-negative Metastatic Breast Cancer
Breast Cancer
Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling
The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were…
- Trial name
- NCT04965064
- Testing
- Capecitabine and Neratinib.
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Rochester
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Metastatic Breast Carcinoma
- Trial name
- ASPIRE (NCT03691493)
- Testing
- Anastrozole, Exemestane, Fulvestrant
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Metastatic Breast Cancer
Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then…
- Trial name
- PEARL (NCT02028507)
- Testing
- Palbociclib, Capecitabine, Exemestane
- Where
- 37 sites in Austria, Hungary and 2 more
- Volunteers
- 693 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without…
- Trial name
- NCT05851014
- Testing
- GB491 combined with Letrozole
- Where
- 52 sites in China
- Volunteers
- 350 people
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with…
- Trial name
- SANDPIPER (NCT02340221)
- Testing
- Taselisib, Fulvestrant
- Where
- 157 sites in United States, Australia and 26 more
- Volunteers
- 631 people
- Sponsor
- Hoffmann-La Roche
Angiogenesis, Breast Cancer
The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative MBC Patients
The purpose of the present study was to prospectively evaluate the efficacy and safety of endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2 negative metastatic breast cancer (MBC)…
- Trial name
- NCT02865304
- Testing
- endostar
- Volunteers
- 80 people
- Sponsor
- Fujian Cancer Hospital
Breast Cancer, Hormone Receptor-positive Breast Cancer
VS-6766+Abema+Fulv in Met HR+/HER- BC
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer.
- Conditions
- Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT05608252
- Testing
- VS-6766, Abemaciclib, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Adrienne G. Waks
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
Estrogen Receptor Negative, Estrogen Receptor Positive
Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT02457910
- Testing
- Biomarker Analysis, Enzalutamide, Pharmacological Study
- Where
- 12 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Locally Recurrent or Metastatic Breast Cancer
Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or…
- Trial name
- NCT01256762
- Testing
- Imetelstat sodium, Bevacizumab, Paclitaxel
- Where
- 55 sites in United States, Canada
- Volunteers
- 166 people
- Sponsor
- Geron Corporation
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
Breast Neoplasms
Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated…
- Trial name
- NCT02258451
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Exemestane, Everolimus
- Where
- 92 sites in United States, Austria and 15 more
- Volunteers
- 283 people
- Sponsor
- Bayer
Estrogen Receptor Negative, HER2/Neu Negative
Tivantinib in Treating Patients With Recurrent or Metastatic Breast Cancer
This phase II trial studies how well tivantinib works in treating patients with recurrent or metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Recurrent Breast Carcinoma
- Trial name
- NCT01575522
- Testing
- Laboratory Biomarker Analysis, Tivantinib
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- National Cancer Institute (NCI)
Breast Neoplasms, Triple Negative Breast Cancer
Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor…
- Conditions
- Breast Neoplasms, Triple Negative Breast Cancer, HR+, HER2-, Advanced Breast Cancer, Breast Cancer
- Trial name
- NCT07018427
- Testing
- Sacituzumab Govitecan Monotherapy or Combination Therapy
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Peking University Cancer Hospital & Institute
HER2-Negative Breast Cancer, Triple Negative Breast Cancer
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese…
- Conditions
- HER2-Negative Breast Cancer, Triple Negative Breast Cancer, Breast Cancer, Cancer of Breast
- Trial name
- NCT02225470
- Testing
- E7389 (Eribulin Mesylate), Vinorelbine injection
- Where
- 35 sites in China
- Volunteers
- 530 people
- Sponsor
- Eisai Co., Ltd.
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
Metastatic Breast Cancer, Advanced Breast Cancer
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment
The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ (FISH-) expressing advanced or metastatic breast…
- Trial name
- NCT00452140
- Testing
- ertumaxomab
- Where
- 5 sites in Austria, France and 3 more
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
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 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
Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00687648
- Testing
- anastrozole, cyclophosphamide, exemestane
- Where
- Singapore
- Volunteers
- 70 people
- Sponsor
- National Cancer Centre, Singapore