Clinical trials: HR+ HER2- Breast Cancer
ctDNA Monitoring, Breast Cancer
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
The goal of this clinical study is to determine whether monitoring ctDNA and treating patients who become ctDNA-positive with abemaciclib can help prevent the recurrence of hormone receptor-positive, HER2-negative breast cancer…
- Trial name
- ARCHE (NCT07292207)
- Testing
- Abemaciclib 150 MG Oral Tablet
- Where
- Japan
- Volunteers
- 30 people
- Sponsor
- Nagoya City University
Breast Cancer
JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer
This is a Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone…
- Trial name
- NCT07784036
- Testing
- JYP0035 plus Fulvestrant
- Volunteers
- 171 people
- Sponsor
- Chengdu JOYO pharma Co., Ltd.
Breast Cancer Metastatic
HR+/HER2- Advanced Breast Cancer and Endocrine Resistance
This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included. The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth…
- Trial name
- PASIPHAE (NCT03322215)
- Testing
- Palbociclib, Fulvestrant, Capecitabine
- Where
- 9 sites in Sweden, United Kingdom
- Volunteers
- 42 people
- Sponsor
- Theodoros Foukakis
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
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Cancer
CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial.
- Trial name
- CIMER (NCT04220476)
- Testing
- Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg
- Sponsor
- Weill Medical College of Cornell University
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 Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative)
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
"This is a randomized phase II, two-arm, open label, clinical trial to identify LP-WGS ctDNA biomarker to predict T-DXd response in low-HER2 expressing advanced breast cancer patients compared with endocrine therapy.
- Trial name
- NCT06837792
- Testing
- Experimental treatment arm, Control treatment arm
- Where
- South Korea
- Volunteers
- 141 people
- Sponsor
- Yonsei University
Metastatic Breast Cancer
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2…
- Trial name
- NCT01288092
- Testing
- BEZ235
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
- Trial name
- BC-MRS-01 (NCT07052734)
- Where
- China
- Volunteers
- 2,843 people
- Sponsor
- Sun Yat-sen University
Metastatic Breast Cancer
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national…
- Trial name
- NCT05132101
- Testing
- Patients who received Palbociclib as first line therapy in MBC setting
- Where
- South Korea
- Volunteers
- 2,758 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer
The purpose of the trial is to investigate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in patients with advanced/metastatic HR+/HER2…
- Trial name
- VinoMetro (NCT03007992)
- Testing
- Vinorelbine
- Where
- 8 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Johannes Gutenberg University Mainz
Breast, Neoplasm Malignant
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients.
- Conditions
- Breast, Neoplasm Malignant, Female
- Trial name
- NCT04524728
- Testing
- Palbociclib, Letrozole 2.5mg, Fulvestrant
- Where
- Italy
- Volunteers
- 191 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Breast Neoplasm, Breast Cancer
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had…
- Conditions
- Breast Neoplasm, Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- NCT05594095
- Testing
- PIK3CA inhibitor, AKT inhibitor, Carrelizumab
- Where
- China
- Volunteers
- 620 people
- Sponsor
- Fudan University
Advanced Breast Cancer
Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)
The HERMIONE-7 trial is a phase II, single-arm, open-label, multicenter study in HR+, HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease.
- Trial name
- HERMIONE-7 (NCT04227327)
- Testing
- Abemaciclib, Aromatase Inhibitors
- Where
- 39 sites in Italy
- Volunteers
- 31 people
- Sponsor
- University of Milano Bicocca
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
Breast Cancer, Endocrine Therapy
Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.
Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4/6i Progression in the Real World has significant implications. This study is an observational, real-world study.
- Conditions
- Breast Cancer, Endocrine Therapy, CDK4/6 Inhibitors, Subsequent Treatment
- Trial name
- NCT06033287
- Testing
- Different treatment regimens following progression on CDK4/6 inhibitors.
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Hunan Cancer Hospital
Breast Cancer
A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.
Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone receptors(ER and/or PR) breast cancer (HEr2+/HR+).
- Trial name
- ADAPT; T-DM1 (NCT01745965)
- Testing
- T-DM1, Trastuzumab
- Where
- 2 sites in Germany
- Volunteers
- 380 people
- Sponsor
- Women's Cancer Study Group GmbH