Clinical trials: Hormone Receptor Negative Breast Carcinoma
Breast Cancer, Cancer of the Breast
Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging.
- Trial name
- NCT04968964
- Testing
- DiviTum® TKa assay, Study Care Plans
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Washington University School of Medicine
Metastatic Breast Cancer
Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
Hormone receptor positive breast cancer is the most common type of breast cancer, comprising 70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for patients with your type of breast cancer.
- Trial name
- NCT00759642
- Testing
- lapatinib
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Kansas Medical Center
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus
This randomized phase II trial studies how well mucoadhesive oral wound rinse works in preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone receptor (PR)-positive metastatic or locally…
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Oral Complications, Progesterone Receptor-positive Breast Cancer
- Trial name
- NCT02015559
- Testing
- mucoadhesive oral wound rinse, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Breast Cancer, Invasive Breast Cancer
Onvansertib + Paclitaxel In TNBC
This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body.
- Conditions
- Breast Cancer, Invasive Breast Cancer, Unresectable Breast Carcinoma, Locally Advanced Breast Cancer
- Trial name
- NCT05383196
- Testing
- Onvansertib, Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Antonio Giordano, MD
Metastatic Breast Cancer
A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).
The goal of the study for patients with metastatic breast cancer (MBC) is to show that palbociclib + endocrine therapy shows a significant improvement in time-to-treatment failure over chemotherapy regimen (mono-chemotherapy with…
- Trial name
- PADMA (NCT03355157)
- Testing
- Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- GBG Forschungs GmbH
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05759949
- Testing
- RLY-5836, Fulvestrant, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Neoplasms
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region
retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2…
- Trial name
- NCT04916509
- Testing
- Palbociclib plus an aromatase inhibitor, Palbociclib plus fulvestrant
- Where
- 7 sites in Qatar, Saudi Arabia and 1 more
- Volunteers
- 258 people
- Sponsor
- Pfizer
Neoplasm Malignant, Epithelial Ovarian Cancer
Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101)
This is a Phase 1, open-label, dose-escalation and expansion study evaluating the safety, tolerability, PK, antitumor activity, and effect on biomarkers of XL102 administered orally alone and in multiple combination regimens to…
- Conditions
- Neoplasm Malignant, Epithelial Ovarian Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- NCT04726332
- Testing
- XL102, Fulvestrant, Abiraterone
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Exelixis
Breast Neoplasms
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast…
- Trial name
- MORPHEUS HR+BC (NCT03280563)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody, Bevacizumab, Entinostat
- Where
- 22 sites in United States, Israel and 1 more
- Volunteers
- 144 people
- Sponsor
- Hoffmann-La Roche
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
Breast Cancer, Breast Neoplasm
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when…
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Female, Breast Cancer Invasive
- Trial name
- RESPONSE (NCT05020860)
- Testing
- Paclitaxel, Carboplatin, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 185 people
- Sponsor
- Baylor Breast Care Center
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
Breast Cancer, Hormone-receptor-positive Breast Cancer
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally…
- Conditions
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer
- Trial name
- NCT07905001
- Testing
- PRT13722, Fulvestrant, Abemaciclib
- Volunteers
- 242 people
- Sponsor
- Prelude Therapeutics Incorporated
Breast Neoplasms
Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated…
- Trial name
- NCT02258451
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Exemestane, Everolimus
- Where
- 92 sites in United States, Austria and 15 more
- Volunteers
- 283 people
- Sponsor
- Bayer
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Metastatic Breast Cancer, Locally Advanced Breast Cancer
Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy
The aim of the present study is to evaluate the efficacy and safety of palbociclib plus fulvestrant after failure of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) plus a CDK4/6 inhibitor, in…
- Trial name
- NCT04318223
- Testing
- Palbociclib
- Where
- 19 sites in Italy
- Volunteers
- 168 people
- Sponsor
- Consorzio Oncotech
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR)…
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
- Trial name
- SUMIT-ELA (NCT05963997)
- Testing
- Samuraciclib, Elacestrant Dihydrochloride
- Where
- 23 sites in United States, France and 2 more
- Volunteers
- 49 people
- Sponsor
- Carrick Therapeutics Limited
HR+/HER2-negative Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria.
- Trial name
- NCT05683418
- Testing
- TOS-358, Fulvestrant, Palbociclib
- Where
- 18 sites in United States, Spain
- Volunteers
- 241 people
- Sponsor
- Totus Medicines
Breast Cancer, Invasive Breast Cancer
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer
This is an exploratory interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for four weeks.
- Trial name
- NCT03219476
- Testing
- Anastrozole, Letrozole, Exemestane
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Medical College of Wisconsin
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals