Clinical trials: Advanced HR+/HER2- Breast Cancer
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.
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, 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
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.
Untreated Early-stage or Locally Advanced Breast Cancer
Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally…
- Trial name
- NCT06592625
- Testing
- SHR-A1811, Adebrelimab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
HR-positive, HER2-negative Advanced Breast Cancer
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.
- Trial name
- NCT06950086
- Testing
- TYK-00540
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- TYK Medicines, Inc
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 (Inoperable) or Metastatic Breast Cancer
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer…
- Trial name
- CAPItello-291 (NCT04305496)
- Testing
- Fulvestrant, Capivasertib
- Where
- 215 sites in United States, Argentina and 17 more
- Volunteers
- 818 people
- Sponsor
- AstraZeneca
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
A Study of PF-06873600 in People With Cancer
The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer.
- Trial name
- NCT03519178
- Testing
- PF-06873600, Endocrine Therapy 1, Endocrine Therapy 2
- Where
- 54 sites in United States, Bulgaria and 4 more
- Volunteers
- 155 people
- Sponsor
- Pfizer
Breast Cancer
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
- Trial name
- NCT02679755
- Testing
- Palbociclib, Letrozole
- Where
- 34 sites in Australia, India
- Volunteers
- 252 people
- Sponsor
- Pfizer
Advanced Solid Tumors, HR+ Breast Cancer
(VELA) Study of BLU-222 in Advanced Solid Tumors
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.
- Conditions
- Advanced Solid Tumors, HR+ Breast Cancer, CCNE1 Amplification, HER2-negative Breast Cancer
- Trial name
- NCT05252416
- Testing
- BLU-222, Carboplatin, Ribociclib
- Where
- 23 sites in United States, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Blueprint Medicines Corporation
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
- 11 sites in United States, Canada and 6 more
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across ~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients.
- Trial name
- SPEAR (NCT05022342)
- Testing
- alpelisib plus fulvestrant
- Where
- 28 sites in India
- Volunteers
- 595 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.
- Trial name
- NCT07071337
- Testing
- SKB264, Nab-paclitaxel, Paclitaxel
- Where
- 2 sites in China
- Volunteers
- 430 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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
Ovarian Neoplasms, Peritoneal Neoplasms
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine.
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms
- Trial name
- NCT05194072
- Testing
- Felmetatug Vedotin, Pembrolizumab
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 250 people
- Sponsor
- Seagen, a wholly owned subsidiary of 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
Advanced, Metastatic Breast Cancer
A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Letrozole SIE (injectable) compared to Femara® (oral tablet), both given together with ribociclib, for the first-line treatment of postmenopausal women with…
- Trial name
- SIE-3 (NCT07340658)
- Volunteers
- 300 people
- Sponsor
- Rovi Pharmaceuticals Laboratories