Clinical trials: HR+, HER2-, Advanced Breast Cancer
Breast Cancer Metastatic
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy [paclitaxel] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human…
- Trial name
- NCT04215146
- Testing
- Paclitaxel, Pelareorep, Avelumab
- Where
- 18 sites in United States
- Volunteers
- 48 people
- Sponsor
- Oncolytics Biotech
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
Advanced Breast Cancer, Metastatic Breast Cancer
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive
- Trial name
- DB-Guide (NCT07683754)
- Testing
- Trastuzumab deruxtecan, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasms
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region
retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2…
- Trial name
- NCT04916509
- Testing
- Palbociclib plus an aromatase inhibitor, Palbociclib plus fulvestrant
- Where
- 7 sites in Qatar, Saudi Arabia and 1 more
- Volunteers
- 258 people
- Sponsor
- Pfizer
Locally Advanced or Metastatic Breast Cancer
YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer
The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally…
- Trial name
- NCT07461454
- Testing
- YL202, Eribulin, Capecitabine
- Where
- China
- Volunteers
- 376 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
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.
Breast Cancer, Small Cell Lung Cancer
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity…
- Conditions
- Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT06257264
- Testing
- BG-68501, Fulvestrant, BGB-43395
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- BeiGene
Triple Negative Breast Cancer, Endometrial Cancer
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.
- Conditions
- Triple Negative Breast Cancer, Endometrial Cancer, Solid Tumor, Unspecified, Adult, Colorectal Cancer
- Trial name
- NCT04577963
- Testing
- Fruquintinib, Tislelizumab
- Where
- 16 sites in United States
- Volunteers
- 52 people
- Sponsor
- Hutchmed
Breast Cancer
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus…
- Trial name
- NCT05504213
- Testing
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.
- Conditions
- High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- RAINFOL-01 (NCT05579366)
- Testing
- Rina-S, Carboplatin, Bevacizumab
- Where
- 67 sites in United States, China and 2 more
- Volunteers
- 952 people
- Sponsor
- Genmab
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor…
- Trial name
- INAVO121 (NCT05646862)
- Testing
- Inavolisib, Fulvestrant, Alpelisib
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal…
- Trial name
- proMONARCH (NCT03988114)
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI)
- Where
- 119 sites in United States, Argentina and 7 more
- Sponsor
- Eli Lilly and Company
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
ESR1 Gene Mutation, Advanced Breast Cancer
Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy.
- Trial name
- NCT06548919
- Testing
- Endocrine therapy, Chemotherapy Prednisone
- Where
- China
- Volunteers
- 450 people
- Sponsor
- SciClone Pharmaceuticals
Breast Cancer, Breast Carcinoma
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors
- Trial name
- NCT05584644
- Testing
- Palbociclib plus hormonal treatment - first line treatment, Palbociclib plus hormonal treatment - second line treatment
- Where
- 6 sites in India
- Volunteers
- 150 people
- Sponsor
- Pfizer
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.
- Trial name
- NCT06929325
- Testing
- Sirolimus for Injection (Albumin-bound), Fulvestrant Injection
- Where
- China
- Volunteers
- 312 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Cancer
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer…
- Trial name
- NCT07648914
- Testing
- BL-B01D1, Albumin-Bound Paclitaxel, Paclitaxel
- Where
- China
- Volunteers
- 446 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally…
- Trial name
- NCT05433480
- Testing
- BPI-16350, Fulvestrant
- Where
- 64 sites in China
- Volunteers
- 274 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.