Clinical trials: Metastatic Breast Cancer (HR+/ HER2-)
Breast Cancer
Fulvestrant or Capecitabine Combined With Pyrotinib in HR+/HER2+ Metastatic Breast Cancer
Capecitabine combined with pyrotinib is the standard protocol for HR+/HER2+ advanced breast cancer after trastuzumab failure, but the incidence of grade 3 hand-foot-syndrome was 16.4%.
- Trial name
- NCT04646759
- Testing
- Fulvestrant combined with Pyrotinib, Capecitabine combined with Pyrotinib
- Where
- China
- Volunteers
- 516 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Advanced Breast Cancer
A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic…
- Trial name
- NCT03927456
- Testing
- SHR6390, Fulvestrant
- Where
- China
- Volunteers
- 357 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth…
- Trial name
- NCT05452798
- Where
- Denmark
- Volunteers
- 1,054 people
- Sponsor
- Pfizer
Breast Cancer
Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer.
- Trial name
- NCT06344793
- Where
- China
- Volunteers
- 608 people
- Sponsor
- Fudan University
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
Breast Cancer
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
- Trial name
- TB06 (NCT07205822)
- Testing
- Dato-DXd
- Where
- 40 sites in United States, China and 4 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal…
- Trial name
- TROPiCS-02 (NCT03901339)
- Testing
- Sacituzumab Govitecan-hziy, Eribulin, Capecitabine
- Where
- 113 sites in United States, Belgium and 7 more
- Volunteers
- 543 people
- Sponsor
- Gilead Sciences
Metastatic Breast Cancer
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after…
- Trial name
- NCT01528345
- Testing
- Dovitinib, Fulvestrant
- Where
- 67 sites in United States, Argentina and 13 more
- Volunteers
- 97 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Advanced and/or Metastatic Breast Cancer
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.
- Trial name
- NCT05044988
- Testing
- HS-10342
- Volunteers
- 20 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
HR+/HER2-negative Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria.
- Trial name
- NCT05683418
- Testing
- TOS-358, Fulvestrant, Palbociclib
- Where
- 18 sites in United States, Spain
- Volunteers
- 241 people
- Sponsor
- Totus Medicines
Breast Cancer
Study of the Impact of Everolimus Treatment on Lymphocytes NK (Natural Killer) Development and Functions for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)
NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of…
- Trial name
- RAPANK (NCT02536625)
- Testing
- prospective study
- Where
- 2 sites in France
- Volunteers
- 62 people
- Sponsor
- Centre Leon Berard
Breast Cancer
Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation
Previous studies have shown that the FGF signaling pathway is closely related to endocrine therapy resistance in breast cancer, but there is not sufficient evidence for the combination of endocrine therapy and FGFR inhibitors.
- Trial name
- NCT04936295
- Testing
- Fulvestrant plus Anlotinib
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Sun Yat-sen University
Breast Cancer, Metastatic Breast Cancer
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- OASIS (NCT04720664)
- Testing
- SM-88
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Breast Cancer
Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment
This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases.
- Trial name
- NCT07467330
- Testing
- dalpiciclib + capecitabine + endocrine therapy, dalpiciclib + endocrine therapy
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Fujian Cancer Hospital
Breast Neoplasms, Breast Diseases
Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast
This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive, HER2-positive breast cancer patients.
- Trial name
- NCT03304080
- Testing
- Anastrozole, Palbociclib, Trastuzumab
- Where
- 5 sites in United States
- Volunteers
- 44 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Breast Cancer Metastatic, Breast Cancer Stage IV
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the…
- Trial name
- SAFIR3LibHERty (NCT06680596)
- Testing
- trastuzumab derxutecan
- Where
- 40 sites in France
- Volunteers
- 80 people
- Sponsor
- UNICANCER
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Metastatic Breast Cancer
Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane
Everolimus will be given to patients with metastatic breast cancer who already has a progress taking Everolimus but with a change in the endocrine treatment.
- Trial name
- Evelyn (NCT01773460)
- Testing
- Everolimus
- Where
- Germany
- Volunteers
- 3 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer
CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial.
- Trial name
- CIMER (NCT04220476)
- Testing
- Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg
- Sponsor
- Weill Medical College of Cornell University