Clinical trials: HR+HER2- Advanced Breast Cancer
Breast Cancer
Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping
To explore the efficacy and safety of Everolimus (SNF1 subtype) or Fluzoparib (SNF3 subtype) combined with Fulvestrant and Abemaciclib vs.
- Trial name
- abemaSNF1/3 (NCT06561022)
- Testing
- Fluzoparib, Everolimus, Fulvestrant
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Fudan University
Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative)
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
"This is a randomized phase II, two-arm, open label, clinical trial to identify LP-WGS ctDNA biomarker to predict T-DXd response in low-HER2 expressing advanced breast cancer patients compared with endocrine therapy.
- Trial name
- NCT06837792
- Testing
- Experimental treatment arm, Control treatment arm
- Where
- South Korea
- Volunteers
- 141 people
- Sponsor
- Yonsei University
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
Advanced Breast Cancer
Dalpiciclib Plus Letrozole and Capecitabine
to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with breast cancer
- Trial name
- NCT05469750
- Testing
- Dalpiciclib+ letrozole +capecitabine
- Volunteers
- 48 people
- Sponsor
- Fujian Medical University Union Hospital
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy
This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+/HER2- locally…
- Trial name
- NCT06998108
- Testing
- BEBT-209 capsules, Fulvestrant Injection
- Where
- China
- Volunteers
- 330 people
- Sponsor
- BeBetter Med Inc
Breast Cancer Metastatic, Renal Cell Carcinoma (RCC)
Sapu003 in Advanced mTOR-sensitive Solid Tumors
This is a phase 1b, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics of Sapu003 in combination with Exemestane in in patients with advanced mTOR-sensitive solid tumors (HR+/HER2-negative…
- Conditions
- Breast Cancer Metastatic, Renal Cell Carcinoma (RCC), Neuroendocrine Tumors, Tuberous Sclerosis Complex (TSC)
- Trial name
- NCT07369505
- Testing
- Sapu003, Exemestane 25 MG
- Where
- Australia
- Volunteers
- 27 people
- Sponsor
- SAPU NANO (US) LLC
Premenopausal Breast Cancer
Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer
This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable locally advanced or metastatic hormonal receptor…
- Trial name
- PEER (NCT02990845)
- Testing
- Pembrolizumab/ Exemestane/ Leuprolide
- Where
- Taiwan
- Volunteers
- 16 people
- Sponsor
- National Taiwan University Hospital
Breast Cancer
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.).
- Trial name
- NCT05266105
- Testing
- Palazestrant, Palbociclib
- Where
- 8 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
This is an open-label, single-arm, phase I trial. It is designed with a conservative dose escalation plan to ensure patient's safety and with a strong translational component to inform if target inhibition is achieved.
- Conditions
- Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor Positive Breast Cancer
- Trial name
- NCT03854903
- Testing
- Palbociclib, Bosutinib, Fulvestrant
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Georgetown University
Breast Neoplasm Female
Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer
This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the…
- Trial name
- NCT05577442
- Testing
- Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
- Volunteers
- 52 people
- Sponsor
- Peking University Cancer Hospital & Institute
Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
The purpose of this clinical trial is to evaluate whether, in patients with hormone receptor-positive (HR-positive) and HER2-positive advanced breast cancer whose disease has progressed after trastuzumab-based therapy, switching…
- Conditions
- Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07892274
- Testing
- Fulvestrant, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 226 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HR-positive, HER2-negative Advanced Breast Cancer
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced…
- Trial name
- NCT04796623
- Testing
- TQB3616 capsules, Fulvestrant injection
- Where
- 17 sites in China
- Volunteers
- 122 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Advanced Breast Cancer, Advanced Breast Carcinoma
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50).
- Conditions
- Advanced Breast Cancer, Advanced Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma
- Trial name
- PONTIAC (NCT06486883)
- Testing
- Trastuzumab deruxtecan (T-DXd, DS-8201a), CDK4/6i plus ET
- Where
- 79 sites in Austria, Belgium and 8 more
- Volunteers
- 200 people
- Sponsor
- MedSIR
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
Breast Cancer, HER2-positive Breast Cancer
Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer
This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4/6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer, HR+/HER2+ Breast Cancer
- Trial name
- FACET (NCT07716046)
- Testing
- Fulvestaciclib, Trastuzumab, Pertuzumab
- Volunteers
- 240 people
- Sponsor
- Fudan University
Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative…
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
- Trial name
- AGATHA (NCT07619066)
- Testing
- Zongertinib (BI 1810631), Fulvestrant
- Volunteers
- 25 people
- Sponsor
- MedSIR
Breast Cancer, Solid Tumors
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2).
- Trial name
- NCT05262400
- Testing
- PF-07220060 + PF-07104091 combination dose escalation, PF-07104091 + PF-07220060 + fulvestrant dose expansion, PF-07104091 + PF-07220060 + letrozole dose expansion
- Where
- 44 sites in United States, Argentina and 7 more
- Volunteers
- 235 people
- Sponsor
- Pfizer
HR Positive/HER-2 Negative Breast Cancer
A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer
This is an open-label, single-arm phase 1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of NTQ1062 in combination with Fulvestrant in patients with locally advanced or…
- Trial name
- NCT06172322
- Testing
- NTQ1062 with Fulvestrant
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Breast Cancer, Advanced HR+/HER2- Breast Cancer
Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable…
- Conditions
- Breast Cancer, Advanced HR+/HER2- Breast Cancer, Advanced Triple-Negative Breast Cancer
- Trial name
- SATROPIN (NCT07367178)
- Testing
- Sacituzumab Govitecan (SG), Atropine, G-CSF (Granulocyte colony-stimulating factor)
- Volunteers
- 30 people
- Sponsor
- MedSIR
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.