Clinical trials: HER2-negative Metastatic Breast Cancer
Metastatic Breast Cancer
Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients
Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some patients will present metastatic recurrence.
- Trial name
- FUMANCE (NCT02383030)
- Testing
- Fulvestrant
- Where
- 20 sites in Italy
- Volunteers
- 156 people
- Sponsor
- Consorzio Oncotech
Breast, Neoplasm Malignant
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients.
- Conditions
- Breast, Neoplasm Malignant, Female
- Trial name
- NCT04524728
- Testing
- Palbociclib, Letrozole 2.5mg, Fulvestrant
- Where
- Italy
- Volunteers
- 191 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
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.
Metastatic Breast Cancer
Maintenance Bevacizumab or Observation After Taxane Based First Line Chemotherapy In Metastatic Breast Cancer
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events)of bevacizumab (Avastin) when combined with standard chemotherapy as first line treatment of patients with metastatic…
- Trial name
- NCT01978977
- Where
- 6 sites in Greece
- Volunteers
- 400 people
- Sponsor
- Hellenic Oncology Research Group
Breast Cancer Metastatic
Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer
This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at…
- Trial name
- AMICA (NCT03555877)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- Germany
- Volunteers
- 56 people
- Sponsor
- GBG Forschungs GmbH
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
Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Adv. or Metastatic Breast Ca
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00934895
- Testing
- everolimus, abraxane
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Rutgers, The State University of New Jersey
ER-Positive, HER2-Negative Breast Cancer
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum…
- Trial name
- NCT04993430
- Testing
- HRS8807, HRS8807、SHR6390
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Immunotherapy, Chemotherapy
Clinical Study of Chemotherapy and Immunotherapy Combined With Lactobacillus Johnsonii in Patients With Multiple Irresectable Solid Tumors
This study plans to enroll 156 patients aged 18-75, who will be randomly divided into two groups to evaluate the clinical efficacy and safety of chemotherapy and immune therapy combined with Lactobacillus johnsonii in patients…
- Trial name
- NCT07191405
- Testing
- oral Lactobacillus johnsonii (1×10¹¹ CFU, twice daily)
- Volunteers
- 156 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Advanced Breast Cancer
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors.
- Trial name
- NCT05861830
- Testing
- The combination of Dalpiciclib with physician-selected endocrine therapy, Chemotherapy selected by the physician
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Peking Union Medical College Hospital
Breast Cancer, Non-small Lung Cancer
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel.
- Trial name
- NCT01862081
- Testing
- Docetaxel, GDC-0032, Paclitaxel
- Where
- 14 sites in United States, Belgium and 2 more
- Volunteers
- 80 people
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
Roll-over Study to Allow Continued Access to Ribociclib
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in…
- Trial name
- NCT05161195
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 73 sites in United States, Argentina and 20 more
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative…
- Trial name
- NCT02049957
- Testing
- Sapanisertib, Fulvestrant, Exemestane
- Where
- 40 sites in United States, Belgium and 1 more
- Volunteers
- 118 people
- Sponsor
- Calithera Biosciences, Inc
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer
8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer
An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment…
- Trial name
- Stop&Go (NCT01935492)
- Testing
- Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine
- Where
- Netherlands
- Volunteers
- 420 people
- Sponsor
- Borstkanker Onderzoek Groep
Estrogen Receptor Negative, HER2/Neu Negative
Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer
This phase I trial studies the side effects and best dose of Galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places…
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Recurrent Breast Carcinoma
- Trial name
- NCT02672475
- Testing
- Galunisertib, Laboratory Biomarker Analysis, Paclitaxel
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases
Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain…
- Trial name
- NCT07745257
- Testing
- Culmerciclib, Anlotinib, Endocrine Therapy
- Where
- 9 sites in China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Breast Cancer Stage IV
Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.
A assessment of the efficacy of first-/second-line endocrine therapies ± target therapies and chemotherapy in real-life of in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer has not yet been…
- Trial name
- NCT04852081
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- Russia
- Volunteers
- 1,000 people
- Sponsor
- Blokhin's Russian Cancer Research Center
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
Breast Cancer
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I…
- Trial name
- NCT02088684
- Testing
- LEE011, BYL719, fulvestrant
- Where
- 11 sites in United States, France and 6 more
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals