Clinical trials: Metastatic HR+/HER2- Breast Cancer
Breast Cancer Metastatic, HR+/HER2- Advanced Breast Cancer
A Real-World Study in Patients With HR+/HER2- Advanced Breast Cancer
The goal of this observational study is to learn about the safety and effectiveness of people with advanced breast cancer that is hormone receptor-positive (HR+), HER2-negative (HER2-).
- Trial name
- NCT07076680
- Where
- China
- Sponsor
- SciClone Pharmaceuticals
Breast Cancer Metastatic
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy…
- Trial name
- ABIGAIL (NCT04603183)
- Testing
- Abemaciclib, Paclitaxel, Letrozole
- Where
- 31 sites in Italy, Portugal and 1 more
- Volunteers
- 162 people
- Sponsor
- MedSIR
Breast Cancer, Metastatic
Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients,
Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+/HER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene…
- Trial name
- L2-268 (NCT06762483)
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- European Institute of Oncology
Breast Cancer, Hormone-receptor-positive Breast Cancer
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally…
- Conditions
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer
- Trial name
- NCT07905001
- Testing
- PRT13722, Fulvestrant, Abemaciclib
- Volunteers
- 242 people
- Sponsor
- Prelude Therapeutics Incorporated
Metastatic Breast Cancer, Advanced Breast Cancer
Implementing Patients´ Competence in Oral Breast Cancer Therapy
The aim of the IMPACT - Implementing Patients' competence in oral breast cancer therapy - study is to evaluate the effectiveness of a standardized patient education and coaching and optional eMBSR for therapy management provided…
- Trial name
- IMPACT (NCT04030728)
- Volunteers
- 212 people
- Sponsor
- Onco Medical Consult GmbH
Breast Cancer, Hormone Receptor Positive Tumor
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- INGE-B (NCT02894398)
- Testing
- Palbociclib, Letrozole, Anastrozole
- Where
- 70 sites in Germany
- Volunteers
- 388 people
- Sponsor
- iOMEDICO AG
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy
BEYOND study is designed to generate the first real-world data from GCC countries on the patient characteristics, treatment patterns, survival outcomes, and safety of T-DXd in patients with HRpositive,HER2-low or HER2-ultralow…
- Trial name
- BEYOND (NCT07597993)
- Testing
- TDxd
- Where
- 9 sites in Oman, Qatar and 2 more
- Volunteers
- 109 people
- Sponsor
- AstraZeneca
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Locally Advanced or Metastatic Breast Cancer
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.
- Trial name
- NCT05860465
- Testing
- SPH4336 Tablets
- Where
- 22 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Breast Cancer Recurrent, HER2/Neu-negative Carcinoma of Breast
Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
This is a clinical trial with a crossover design to determine patients' preference for capecitabine in combination with bevacizumab or everolimus in combination with exemestane for advanced breast cancer patients and to evaluate…
- Conditions
- Breast Cancer Recurrent, HER2/Neu-negative Carcinoma of Breast, Hormone Receptor Positive Malignant Neoplasm of Breast
- Trial name
- IMPROVE (NCT02248571)
- Testing
- Bevacizumab, Capecitabine, Everolimus
- Where
- Germany
- Volunteers
- 85 people
- Sponsor
- iOMEDICO AG
Breast Cancer, Malignant Neoplasm of Breast
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor…
- Trial name
- NCT06495164
- Testing
- Palbociclib, Aromatase inhibitor, Ribociclib
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Triple-negative Breast Cancer and HR+/HER2- BC
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC…
- Trial name
- NCT05445908
- Testing
- SKB264, KL-A167
- Where
- 2 sites in China
- Volunteers
- 184 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Neoplasms
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone…
- Trial name
- NCT04895358
- Testing
- pembrolizumab, paclitaxel, nab-paclitaxel
- Where
- 256 sites in United States, Argentina and 29 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow…
- Trial name
- NCT07757230
- Testing
- SSGJ-612 (HER2-targeted antibody), HER2-targeted ADC
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Breast Cancer Stage IV
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was…
- Trial name
- SAFIR 03 (NCT05625087)
- Testing
- Alpelisib, Ribociclib
- Where
- 44 sites in France
- Volunteers
- 4 people
- Sponsor
- UNICANCER
Malignant Neoplasm of Breast
Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)
The primary objective of this Phase 2 Simon 2-Stage study is to determinate the Overall Response Rate (ORR) per RECIST v1.1 following treatment with Imprime PGG + pembrolizumab in patients with ER/PR+/ HER2(-) metastatic breast…
- Trial name
- NCT05159778
- Testing
- Imprime PGG, Pembrolizumab
- Where
- 16 sites in United States
- Volunteers
- 26 people
- Sponsor
- HiberCell, Inc.
Metastatic Breast Cancer
Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a…
- Trial name
- NCT05153135
- Testing
- Ribociclib, Palbociclib, Abemaciclib
- Where
- United States
- Volunteers
- 4,320 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer, Metastatic Breast Cancer
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma
- Trial name
- NCT05191004
- Testing
- NUV-422, Fulvestrant
- Where
- 5 sites in United States
- Sponsor
- Nuvation Bio Inc.