Clinical trials: HR+/HER2- Locally Advanced, Metastatic Breast Cancer, open to volunteers
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
Advanced Solid Tumors
A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors.
- Trial name
- NCT07767474
- Testing
- ATX-898, ATX-898, fulvestrant, ribociclib
- Where
- 6 sites in United States, Australia
- Volunteers
- 343 people
- Sponsor
- Antares Therapeutics, Inc
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Metastatic Breast Cancer, Advanced Breast Cancer
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and…
- Trial name
- ICARUS BREAST (NCT04965766)
- Testing
- U3-1402
- Where
- 11 sites in France
- Volunteers
- 139 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive…
- Trial name
- NCT06439771
- Testing
- YL202 should be intravenously infused
- Where
- China
- Volunteers
- 180 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
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.
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
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
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
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.
Metastatic Breast Cancer
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
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.
- Trial name
- NCT06081959
- Testing
- SKB264, Eribulin, Capecitabine
- Where
- China
- Volunteers
- 376 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive…
- Trial name
- optINAVO (NCT07368998)
- Testing
- Inavolisib, Fulvestrant
- Where
- 34 sites in United States, Argentina and 6 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
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
Breast Cancer
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally…
- Trial name
- NCT06642545
- Testing
- Disitamab Vedotin, RC148, Albumin-bound Paclitaxone
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
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, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Advanced or Metastatic Breast Cancer
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
The study will evaluate the safety, pharmacokinetics, and preliminary activity of GDC-4198 when given in combination with endocrine therapy (ET) (letrozole, fulvestrant, or giredestrant) as first-line treatment to participants…
- Trial name
- FrontROSE (NCT07867262)
- Testing
- GDC-4198, Fulvestrant, Letrozole
- Volunteers
- 165 people
- Sponsor
- Genentech, Inc.
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.