Clinical trials: Hormone Receptor Positive Breast Carcinoma
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 Metastatic
Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer
Background: Endocrine therapy is an effective and safe treatment for hormone receptor positive breast cancer. Unfortunately , endocrine treatment resistance occurs and there is an urgent need for treatment alternative.
- Trial name
- NCT03045653
- Testing
- Tamoxifen Oral Product
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
- Trial name
- NCT03393845
- Testing
- Pembrolizumab, Fulvestrant
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- Nancy Chan, MD
Hormone Receptor Positive Early Breast Cancer
A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer
The study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole…
- Trial name
- SIE-1 (NCT07401381)
- Testing
- US-sourced oral Femara® + Letrozole SIE, EU sourced oral Femara® + Letrozole SIE
- Where
- 21 sites in United States, Serbia and 1 more
- Volunteers
- 120 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04086875
- Testing
- Focus Group, Text Message, Best Practice
- Where
- 7 sites in United States
- Volunteers
- 332 people
- Sponsor
- Thomas Jefferson University
Breast Cancer
Efficacy and Safety of 500mg of Fulvestrant
Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness.
- Trial name
- NCT00585507
- Testing
- Fulvestrant
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Beth Israel Deaconess Medical Center
Breast Cancer Metastatic
Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer
This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at…
- Trial name
- AMICA (NCT03555877)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- Germany
- Volunteers
- 56 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer
Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer
In this study we plan to study the combination of ZD6474, a dual inhibitor of EGFR and VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast cancer.
- Trial name
- NCT00481845
- Testing
- Vandetanib, Anastrozole
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stanford University
Breast Cancer, HER2-negative Breast Cancer
Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
This phase II is studying the side effects and how well carboplatin and paclitaxel albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab before surgery works in treating patients with stage…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT00618657
- Testing
- Carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, bevacizumab
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- University of California, Irvine
Breast Cancer, HER2-positive Breast Cancer
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
- Trial name
- NCT04030507
- Testing
- MRI
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- Brigham and Women's Hospital
Breast Cancer, Early-Stage Breast Carcinoma
SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers
SOLIS is a prospective, single-arm, single-institution pilot trial evaluating single-fraction stereotactic radiotherapy (24 Gy to the planning target volume with a simultaneous integrated boost of 30 Gy to the clinical target…
- Conditions
- Breast Cancer, Early-Stage Breast Carcinoma, Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- SOLIS (NCT07844759)
- Testing
- Stereotactic Radiation Therapy, Endocrine Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Renaissance Institute of Precision Oncology and Radiosurgery
Breast Cancer
Endocrine Therapy Base on 21-gene RS
Among patients aged ≤50 years with hormone receptor-positive, HER2-negative breast cancer and pathologic nodal stage pN0-1-limited to those with an Oncotype DX® Recurrence Score (RS) of 11-25 for pN0 and ≤25 for pN1-, we will…
- Trial name
- CUSTOM (NCT07311122)
- Testing
- Oncotype DX
- Volunteers
- 4,000 people
- Sponsor
- Gangnam Severance Hospital
Early Breast Cancer
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive…
- Trial name
- NCT06341894
- Testing
- Dalpiciclib, Endocrine therapy
- Where
- China
- Volunteers
- 1,163 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer, Adherence, Medication
Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
1. The primary objective is to compare rates of persistence (continuation) of any endocrine therapy (ET) between patients assigned to standard of care follow-up (control arm) versus standard of care plus a bi-directional text…
- Conditions
- Breast Cancer, Adherence, Medication, Side Effect
- Trial name
- NCT03949270
- Testing
- BETA-Text text messaging intervention
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Yale University
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
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 (MBC), HER2-Positive Breast Cancer
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
The purpose of this clinical trial is to evaluate whether, in patients with hormone receptor-positive (HR-positive) and HER2-positive advanced breast cancer whose disease has progressed after trastuzumab-based therapy, switching…
- Conditions
- Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07892274
- Testing
- Fulvestrant, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 226 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasms, Lung Neoplasms
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive ([HR+]…
- Trial name
- NCT06974604
- Testing
- Dexamethasone oral
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brown University
Breast Cancer, Locoregional Recurrence
Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)
The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone…
- Conditions
- Breast Cancer, Locoregional Recurrence, Abemaciclib, Endocrine Therapy
- Trial name
- AURA (NCT07190443)
- Testing
- Endocrine therapy + Abemaciclib, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Where
- Japan
- Volunteers
- 290 people
- Sponsor
- Japanese Foundation for Cancer Research
Breast Cancer, Cancer
A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy
Endocrine therapy is the initial treatment for most hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancers.
- Trial name
- NCT04274933
- Testing
- Venetoclax, Capecitabine
- Where
- 18 sites in United States, Germany and 2 more
- Volunteers
- 4 people
- Sponsor
- AbbVie