Clinical trials: Advanced HR+/HER2- Breast Cancer
PIK3CA Mutations, Advanced Solid Tumors, Adult
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of…
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer
- Trial name
- NCT07383506
- Testing
- CGT6297
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cogent Biosciences, Inc.
Advanced HR+/HER2- Breast Cancer
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone…
- Trial name
- NCT07604571
- Testing
- IEV407, Fulvestrant, Letrozole
- Where
- 10 sites in United States, Canada and 5 more
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
HR Positive HER2 Negative Advanced Breast Cancer
Iribrine Plus Tucidinostat in the Treatment of HR+/HER2 Advanced Breast Cancer After CDK4/6 Inhibitor Failure
To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer
- Trial name
- NCT05335473
- Testing
- Eribulin and Tucidinostat
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Henan Cancer Hospital
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
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Advanced Solid Tumor, HR+/HER2- Breast Cancer
Study of AVZO-021 in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification
- Trial name
- NCT05867251
- Testing
- AVZO-021, Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Avenzo Therapeutics, Inc.
Advanced Breast Cancer, HR+/HER2- Breast Cancer
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer.
- Trial name
- NCT06447623
- Testing
- Apatinib, CDK4/6 Inhibitor, Aromatase inhibitor and Fulvestrant
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Fudan University
HR+ / HER2- Advanced Breast Cancer
Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast Cancer
This study is a prospective, single-arm, multicenter phase II clinical trial. The study plans to enroll 40 patients with HR+/HER2- advanced breast cancer to explore the efficacy and safety of patients receiving olmesartan…
- Trial name
- NCT07810088
- Testing
- Treatment
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 18 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Extensive-stage Small Cell Lung Cancer
- Trial name
- NCT06726148
- Testing
- ECI830, ribociclib, fulvestrant
- Where
- 33 sites in United States, Australia and 14 more
- Volunteers
- 280 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer
ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors
This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid…
- Trial name
- AVZO-023-1001 (NCT06998407)
- Testing
- AVZO-021, Fulvestrant, Letrozole
- Where
- 16 sites in United States
- Volunteers
- 380 people
- Sponsor
- Avenzo Therapeutics, Inc.
Breast Cancer, HR-positive Breast Cancer
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment. The goal of this study is 1.
- Conditions
- Breast Cancer, HR-positive Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- CAPIcorn (NCT07281833)
- Testing
- Capivasertib
- Where
- 16 sites in Belgium, Germany and 1 more
- Volunteers
- 250 people
- Sponsor
- Women's Cancer Study Group GmbH
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 13 sites in United States
- Volunteers
- 260 people
- Sponsor
- Pfizer
Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose…
- Conditions
- Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Metastatic Urothelial Cancer
- Trial name
- ASCENT-J02 (NCT05101096)
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 36 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Gilead Sciences
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Trial name
- NCT07570966
- Testing
- ERW316, Fulvestrant, Letrozole
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Advanced Breast Cancer
Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study
A phase 1B study to explore the maximum tolerated dose (MTD) of dalpiciclib + chidamide in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy
- Trial name
- NCT05586841
- Testing
- Dalpiciclib, Chidamide
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Beijing 302 Hospital
HR+ / HER2- Advanced Breast Cancer
A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer.
Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer
- Trial name
- NCT07557004
- Testing
- SH3765+Fulvestrant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
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.
HR-positive,HER2-negative in Advanced Breast Cancer
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail
This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen…
- Trial name
- NCT05375461
- Testing
- TQB3616 capsules, Fluvestrin injection
- Where
- 2 sites in China
- Volunteers
- 293 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.