Clinical trials: Metastatic HR+/HER2- Breast Cancer
Solid Tumor
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
This is a first in human, single arm, open label, Phase 1a/1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.
- Trial name
- NCT03970382
- Testing
- NeoTCR-P1 adoptive cell therapy, nivolumab, IL-2
- Where
- 9 sites in United States
- Volunteers
- 21 people
- Sponsor
- PACT Pharma, Inc.
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 254 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Metastatic Breast Cancer
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+…
- Trial name
- NCT06018337
- Testing
- DB-1303/BNT323, Capecitabine, Paclitaxel
- Where
- 258 sites in United States, Argentina and 15 more
- Volunteers
- 541 people
- Sponsor
- DualityBio Inc.
HR+/HER2- Advanced or Metastatic Breast Cancer
Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China
This study aims to fill the current gap in data regarding HR+/HER2- ABC 1L treatment patterns and outcomes in the real-world setting in China, especially in the context of the widespread application of CDK4/6is and the lack of…
- Trial name
- NCT07476170
- Where
- China
- Volunteers
- 14,000 people
- Sponsor
- Novartis Pharmaceuticals
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, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Breast Cancer
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine…
- Trial name
- NCT05104866
- Testing
- Dato-DXd, Capecitabine, Gemcitabine
- Where
- 167 sites in United States, Argentina and 18 more
- Volunteers
- 732 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR)…
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
- Trial name
- SUMIT-ELA (NCT05963997)
- Testing
- Samuraciclib, Elacestrant Dihydrochloride
- Where
- 23 sites in United States, France and 2 more
- Volunteers
- 49 people
- Sponsor
- Carrick Therapeutics Limited
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Metastatic Breast Cancer
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic)…
- Trial name
- NCT03096847
- Testing
- ribociclib, letrozole, goserelin
- Where
- 84 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer
The purpose of the trial is to investigate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in patients with advanced/metastatic HR+/HER2…
- Trial name
- VinoMetro (NCT03007992)
- Testing
- Vinorelbine
- Where
- 8 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Johannes Gutenberg University Mainz
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
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole 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 Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2…
- Trial name
- NCT03966898
- Testing
- SHR6390 Tablets, Letrozole or Anastrozole Tablets
- Where
- China
- Volunteers
- 426 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer, Endocrine Therapy
Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.
Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4/6i Progression in the Real World has significant implications. This study is an observational, real-world study.
- Conditions
- Breast Cancer, Endocrine Therapy, CDK4/6 Inhibitors, Subsequent Treatment
- Trial name
- NCT06033287
- Testing
- Different treatment regimens following progression on CDK4/6 inhibitors.
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Hunan Cancer Hospital
Metastatic Breast Cancer
Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer
This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative…
- Trial name
- NCT04263298
- Testing
- Fulvestrant, Capecitabine Oral Product
- Where
- 13 sites in China
- Volunteers
- 210 people
- Sponsor
- Herui Yao
Breast Cancer
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer
This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.
- Trial name
- BEST (NCT02853071)
- Testing
- Estramustine, standard practice
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Metastatic (Stage IV) Melanoma
Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.
Although treatments for breast cancer have improved, 20-30% of patients with early disease develop metastases (cancer that spreads to other parts of the body).
- Trial name
- EPIBREAST (NCT07340619)
- Testing
- prifetrastat monotherapy for 15 days then combination with fulvestrant, prifetrastat in combination with fulvestrant
- Where
- 8 sites in France
- Volunteers
- 51 people
- Sponsor
- UNICANCER
Breast Cancer Metastatic
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05759546
- Testing
- Fluzoparib, Dalpiciclib, Fulvestrant/AI
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Fudan University
Breast Cancer Metastatic
Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer
▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment
- Trial name
- NCT06849947
- Testing
- Ribociclib with fulvestrant, Physician's choice treatments group
- Volunteers
- 272 people
- Sponsor
- Yeon Hee Park
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals