Clinical trials: Hormone Receptor Positive, HER2 Negative Breast Cancer
Metastatic Breast Cancer
Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Aromatase inhibitor (AI) + CDK4/6 inhibitor is settled down as the standard first line therapy for HR+/HER2- metastatic breast cancer and all three CDk4/6 inhibitors, palbociclib, ribociclib, and abemaciclib are currently…
- Trial name
- NCT05816655
- Testing
- Fulvestrant plus AI plus ribociclib, AI plus ribociclib
- Where
- 2 sites in South Korea
- Volunteers
- 202 people
- Sponsor
- Korea University Guro Hospital
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
Breast Cancer
Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in breast cancer tumor growth, its ability to spread, and its ability to form new blood vessels.
- Trial name
- NCT01441947
- Testing
- Cabozantinib, Fulvestrant
- Where
- 4 sites in United States
- Volunteers
- 68 people
- Sponsor
- Massachusetts General Hospital
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04348747
- Testing
- Anti-HER2/HER3 Dendritic Cell Vaccine, Pembrolizumab
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Roswell Park Cancer Institute
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Locoregional Recurrence, Hormone Receptor-positive Breast Cancer
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
- Conditions
- Locoregional Recurrence, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- RaPhLRR (NCT05467891)
- Testing
- Ribociclib, Fulvestrant, Anastrozole
- Where
- 21 sites in United States
- Volunteers
- 200 people
- Sponsor
- Oana Danciu
Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by…
- Conditions
- Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Progesterone Receptor-negative Breast Cancer
- Trial name
- NCT00194779
- Testing
- doxorubicin hydrochloride, cyclophosphamide, paclitaxel
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Washington
Fasting Mimicking Diet, HER2-negative Breast Cancer
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer
In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy.
- Conditions
- Fasting Mimicking Diet, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer, Pathological Complete Response
- Trial name
- DIRECT-2 (NCT05503108)
- Testing
- Fasting Mimicking diet program
- Where
- 7 sites in Netherlands
- Volunteers
- 10 people
- Sponsor
- Leiden University Medical Center
Metastatic Breast Cancer
Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen treatment.
- Trial name
- LEO (NCT02344550)
- Testing
- Everolimus(afinitor), Letrozole, Leuprolide(Lorelin Depot)
- Where
- South Korea
- Volunteers
- 137 people
- Sponsor
- Asan Medical Center
Early Breast Cancer, Adjuvant Therapy
Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast…
- Conditions
- Early Breast Cancer, Adjuvant Therapy, Hormone Receptor Positive / HER2-negative Breast Cancer
- Trial name
- NCT07101159
- Testing
- Dalpiciclib, Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
- Volunteers
- 200 people
- Sponsor
- Fujian Cancer Hospital
Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma
Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients…
- Conditions
- Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
- Trial name
- NCT07796880
- Testing
- Culmerciclib, Aromatase Inhibitor (AI)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasms, Breast Cancer
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
- Trial name
- I-SPY (NCT01042379)
- Testing
- Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin
- Where
- 42 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA
The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms, Neoplasms, Breast, Breast Diseases
- Trial name
- MAGNETIC1 (NCT05814224)
- Testing
- Liquid biopsy and CT scan
- Where
- 7 sites in Italy
- Volunteers
- 164 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative
- Trial name
- NCT02115282
- Testing
- Biospecimen Collection, Computed Tomography, Entinostat
- Where
- 653 sites in United States, South Africa
- Volunteers
- 608 people
- Sponsor
- National Cancer Institute (NCI)
HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer, HER2-negative Circulating Tumor Cells
DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
Several studies have indicated that determining prevalence and number of circulating tumor cells (CTCs) at various time points during treatment may be an effective tool for assessing treatment efficacy in metastatic breast cancer…
- Conditions
- HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer, HER2-negative Circulating Tumor Cells, Postmenopausal Female Patients
- Trial name
- NCT02035813
- Testing
- Ribociclib, Eribulin
- Where
- Germany
- Volunteers
- 116 people
- Sponsor
- Prof. Wolfgang Janni
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
- Trial name
- NCT06797635
- Testing
- Patritumab deruxtecan, Pembrolizumab, Paclitaxel
- Where
- 17 sites in United States, South Korea and 2 more
- Volunteers
- 372 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer.
- 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
- NCT05464810
- Testing
- Letrozole, Simvastatin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Emory University
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