Clinical trials: Hormone Receptor Positive, HER2 Negative Breast Cancer
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
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
Neoplasms, Breast Neoplasms
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: Xentuzumab in combination with abemaciclib Xentuzumab in combination with abemaciclib and hormonal therapies…
- Trial name
- NCT03099174
- Testing
- Xentuzumab, Abemaciclib, Letrozole
- Where
- 30 sites in United States, Denmark and 5 more
- Volunteers
- 133 people
- Sponsor
- Boehringer Ingelheim
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal…
- Trial name
- proMONARCH (NCT03988114)
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI)
- Where
- 119 sites in United States, Argentina and 7 more
- Sponsor
- Eli Lilly and Company
Breast Cancer, HER2-negative Breast Cancer
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer
PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Premenopausal Breast Cancer
- Trial name
- SOLTI-2104 (NCT05982093)
- Testing
- Elacestrant, Triptorelin, Tamoxifen 20 mg
- Where
- 15 sites in Spain
- Volunteers
- 96 people
- Sponsor
- SOLTI Breast Cancer Research Group
Metastatic Breast Cancer
A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.
The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel.
- Trial name
- NCT04671615
- Testing
- palbociclib
- Where
- Israel
- Volunteers
- 559 people
- Sponsor
- Pfizer
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
- 50 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Urothelial Carcinoma, Triple Negative Breast Cancer
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4…
- Conditions
- Urothelial Carcinoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT05234606
- Testing
- SBT6290, pembrolizumab
- Sponsor
- Silverback Therapeutics
Breast Cancer, HER2-negative Breast Cancer
CLEAR-B: Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer
This is a non-interventional retrospective cohort study of premenopausal patients with HR+/HER2- breast cancer who are treated in the adjuvant setting with either Tamoxifen, Tamoxifen + Ovarial Function Suppression or Aromatase…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- CLEAR-B (NCT05870813)
- Where
- Germany
- Volunteers
- 3,000 people
- Sponsor
- Institut fuer Frauengesundheit
Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/Her2-) breast…
- Trial name
- FITWISE (NCT06518837)
- Testing
- Tirzepatide
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Rutgers, The State University of New Jersey
Metastatic Breast Cancer
Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer
This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative metastatic, unresectable breast cancer.
- Trial name
- SHERBOC (NCT03241810)
- Testing
- Seribantumab, Fulvestrant
- Where
- 59 sites in United States, Austria and 4 more
- Volunteers
- 22 people
- Sponsor
- Elevation Oncology
Breast Cancer
A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors
Ciclibiome is a prospective study including BC patients starting treatment with a CDK4/6 inhibitor (in the metastatic and in the adjuvant setting).
- Trial name
- CICLIBIOME (NCT06171360)
- Where
- 3 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy
This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Negative Breast Carcinoma
- Trial name
- NCT04379570
- Testing
- Educational Intervention, Text Message-based Navigation Intervention, Motivational Interviewing
- Where
- 526 sites in United States
- Volunteers
- 1,167 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Cancer
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus…
- Trial name
- NCT05504213
- Testing
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent…
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT06756932
- Testing
- BGB-21447, Fulvestrant, BGB-43395
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- BeOne Medicines
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 Cancer, Metastatic Breast Cancer
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- OASIS (NCT04720664)
- Testing
- SM-88
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Brest Cancer, CDK4/6 Inhibitor
Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients
This study aims to evaluate the efficacy and safety of branded palbociclib (Ibrance®) compared to available local generic formulations (Palbociclib-IPI) in Iraqi patients with hormone receptor-positive, human epidermal growth…
- Trial name
- PALLAS-IRAQ (NCT07493291)
- Testing
- Palbociclib (Brand vs Generic) compartive
- Where
- Iraq
- Volunteers
- 100 people
- Sponsor
- Al-Mustansiriyah University
Metastatic Breast Cancer, Drug Resistance
Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd
This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including…
- Conditions
- Metastatic Breast Cancer, Drug Resistance, Hormone Receptor-Positive Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT07073755
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hunan Cancer Hospital
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative