Clinical trials: HR+HER2- Breast Cancer
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
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
HR+/HER2- Advanced and/or Metastatic Breast Cancer
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.
- Trial name
- NCT05044988
- Testing
- HS-10342
- Volunteers
- 20 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Breast Cancer
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination.
- Trial name
- NCT02023359
- Testing
- Everolimus and exemestane
- Where
- 3 sites in Denmark
- Volunteers
- 7 people
- Sponsor
- Novartis Healthcare A/S
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.
Advanced/Metastatic HER2-negative Breast Cancer
Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in…
- Trial name
- NCT06975371
- Testing
- No drug
- Where
- United States
- Volunteers
- 1,415 people
- Sponsor
- Daiichi Sankyo
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 Breast Cancer
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
This study adopts multicenter/randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy.
- Trial name
- NCT06941142
- Testing
- Sirolimus (albumin - bound), Palbociclib tablet, Fulvestrant injection
- Volunteers
- 382 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology 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-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast…
- Trial name
- NCT07678957
- Testing
- BL-M07D1, DS-8201
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
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.
Metastatic Breast Cancer
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+…
- Trial name
- NCT06018337
- Testing
- DB-1303/BNT323, Capecitabine, Paclitaxel
- Where
- 258 sites in United States, Argentina and 15 more
- Volunteers
- 541 people
- Sponsor
- DualityBio 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.
Breast Cancer
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer
The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system's response to cancer.
- Trial name
- AWARE-1 (NCT04102618)
- Testing
- Pelareorep, Letrozole, Atezolizumab
- Where
- 14 sites in Spain
- Volunteers
- 26 people
- Sponsor
- Oncolytics Biotech
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
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.
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
Breast Cancer
A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Trial name
- NCT07358377
- Testing
- HRS-6209 Capsules and fulvestrant injection
- Where
- 6 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Atridia Pty Ltd.
HR+HER2- Advanced Breast Cancer
A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation
This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in…
- Trial name
- PARFENOPA (NCT06625333)
- Where
- 20 sites in Russia
- Volunteers
- 329 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC)…
- Trial name
- LEEWARD (NCT07647042)
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- Novartis Pharmaceuticals