Clinical trials: Hormone Receptor Positive, HER2 Negative Breast Cancer
Breast Cancer
Trastuzumab Deruxtecan Plus ivonescImab for Hormone Receptor-positive HER2 Negative Advanced Breast Cancer Study
The UNITY study is a prospective, single-arm, single-center, Phase II clinical trial conducted by Fudan University Shanghai Cancer Center.
- Trial name
- NCT07647016
- Testing
- Trastuzumab Deruxtecan and ivonescimab
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Fudan University
Breast Cancer
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant…
- Trial name
- NCT06106477
- Testing
- Intermittent Fasting
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Breast Cancer
Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer
To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
- Trial name
- NCT07180056
- Testing
- CDK4/6 inhibitor
- Where
- China
- Volunteers
- 229 people
- Sponsor
- Wenjin Yin
Metastatic Breast Cancer
PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer
This is an open label, randomized, multicenter, international phase II study for premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally advanced breast cancer.
- Trial name
- FATIMA (NCT02917005)
- Testing
- Palbociclib, Exemestane, Goserelin
- Where
- South Africa
- Volunteers
- 160 people
- Sponsor
- Hamdy A. Azim
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
- Trial name
- NCT00721409
- Testing
- PD 0332991, letrozole
- Where
- 104 sites in United States, Canada and 10 more
- Volunteers
- 177 people
- Sponsor
- Pfizer
Breast Cancer
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy…
- Trial name
- NCT06086340
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 779 people
- Sponsor
- Pfizer
Breast Cancer
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor.
- Trial name
- NCT07258108
- Testing
- Lucanisatuzumab plus tagolimumab
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Sun Yat-sen University
Breast Cancer, Breast Neoplasms
Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Neoplasm Female, Breast Cancer Female
- Trial name
- CAPTOR-BC (NCT05452213)
- Testing
- Ribociclib
- Where
- 52 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut fuer Frauengesundheit
Breast Cancer
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Early Breast Cancer
This Clinical Trial is a Retrospective, Multicenter Cohort Study Evaluating the Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer.
Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy.
- Trial name
- PRIORITY (NCT07309887)
- Where
- South Korea
- Volunteers
- 100,000 people
- Sponsor
- Samsung Medical Center
HER2-positive Breast Cancer, Invasive Carcinoma of the Breast
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Invasive Carcinoma of the Breast, Breast Cancer, Node Negative Breast Cancer
- Trial name
- ADEPT (NCT04569747)
- Testing
- Pertuzumab+TRASTUZUMAB, ADJUVANT ENDOCRINE THERAPY
- Where
- 32 sites in United States
- Volunteers
- 393 people
- Sponsor
- Dana-Farber Cancer Institute
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
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
Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma
Effects of Ribociclib and Palbociclib on Tumor and Blood Characteristics in Patients With Metastatic Breast Cancer
This clinical trial attempts to understand the differences between two chemotherapy drugs, ribociclib and palbociclib, and how they fight cancer.
- Conditions
- Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Trial name
- NCT05244434
- Testing
- Best Practice, Biopsy, Biospecimen Collection
- Sponsor
- City of Hope Medical Center
Metastatic Breast Cancer
Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer.
- Trial name
- NCT00597597
- Testing
- Erlotinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Rush University Medical Center
Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Adenocarcinoma
Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial
This phase I trial is to find out the best dose, possible benefits and/or side effects of NHS-IL12 given together with bintrafusp alfa and radiation therapy in treating patients with hormone receptor positive, HER2 negative…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic HER2 Negative Breast Adenocarcinoma
- Trial name
- NCT04756505
- Testing
- Bintrafusp Alfa, Immunocytokine NHS-IL12, Radiation Therapy
- Sponsor
- M.D. Anderson Cancer Center
Breast
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2
- Trial name
- NCT06791161
- Testing
- Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
- Conditions
- Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer, Early-Stage Breast Cancer, HER2-negative Breast Cancer
- Trial name
- DNADalHR (NCT06970912)
- Testing
- Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy, Taxane-Based Neoadjuvant Chemotherapy
- Where
- China
- Volunteers
- 393 people
- Sponsor
- Peking University People's Hospital