Clinical trials: Hormone Receptor Negative Breast Carcinoma
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
Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started…
- Trial name
- NCT06463626
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Novartis
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)
Early-stage Breast Cancer
Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients
Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in…
- Trial name
- NCT00309478
- Testing
- Cyclophosphamide, Methotrexate, Fluorouracil implant
- Volunteers
- 1,099 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
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
Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC)
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors…
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer
- Trial name
- NCT07020117
- Testing
- [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
- Where
- 14 sites in United States
- Volunteers
- 150 people
- Sponsor
- Aktis Oncology, Inc.
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
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Female Breast Carcinoma, Breast Cancer
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after…
- Trial name
- NCT02942355
- Testing
- anastrozole, Palbociclib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
PALbociclib CoLlaborative Adjuvant Study
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early…
- Trial name
- PALLAS (NCT02513394)
- Testing
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Where
- 437 sites in United States, Australia and 19 more
- Volunteers
- 5,796 people
- Sponsor
- Alliance Foundation Trials, LLC.