Clinical trials: Hormone Receptor Negative Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases
This phase I/II trial studies the best dose and effect of pimasertib in combination with bintrafusp alfa in treating patients with cancer that has spread to the brain (brain metastases).
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Hematopoietic and Lymphoid Cell Neoplasm, Hormone Receptor Positive Breast Adenocarcinoma
- Trial name
- NCT04789668
- Testing
- Bintrafusp Alfa, Pimasertib, Quality-of-Life Assessment
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, Breast Cancer - Female
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women…
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Trial name
- NCT02586675
- Testing
- Tamoxifen, Ribociclib, Goserelin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).
- Trial name
- JBCRG-26 (NCT04736576)
- Testing
- Wearable device
- Where
- 20 sites in Japan
- Volunteers
- 99 people
- Sponsor
- Pfizer
Post Menopausal Breast Cancer
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer…
- Trial name
- EVEREXES (NCT03176238)
- Testing
- everolimus, exemestane
- Where
- 55 sites in Australia, India and 11 more
- Volunteers
- 235 people
- Sponsor
- Novartis Pharmaceuticals
Estrogen Receptor-positive Breast Cancer, Progesterone Receptor-negative Breast Cancer
F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in predicting response to first-line hormone therapy in women with hormone receptor-positive metastatic breast cancer.
- Conditions
- Estrogen Receptor-positive Breast Cancer, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT00602043
- Testing
- F-18 16 alpha-fluoroestradiol, fludeoxyglucose F 18, positron emission tomography
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal hormone receptor-positive (HR+)…
- Trial name
- TATEN (NCT04251169)
- Testing
- Pembrolizumab, Paclitaxel
- Where
- 7 sites in Spain
- Volunteers
- 20 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Cancer
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib…
- Trial name
- IPATunity150 (NCT04060862)
- Testing
- Ipatasertib, Palbociclib, Fulvestrant
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7
Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery.
- Conditions
- Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7
- Trial name
- NCT00861705
- Testing
- Bevacizumab, Carboplatin, Cyclophosphamide
- Where
- 448 sites in United States
- Volunteers
- 454 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
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
Breast Adenocarcinoma, Hormone Receptor Positive
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone…
- Conditions
- Breast Adenocarcinoma, Hormone Receptor Positive, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
- Trial name
- TAILORx (NCT00310180)
- Testing
- Anastrozole, Exemestane, Laboratory Biomarker Analysis
- Where
- 1,222 sites in United States, Australia and 6 more
- Volunteers
- 10,273 people
- Sponsor
- National Cancer Institute (NCI)
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
Invasive Breast Cancer, Metastatic Breast Cancer
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer.
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT04448886
- Testing
- Pembrolizumab, Sacituzumab Govitecan
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Ana C Garrido-Castro, MD
Breast Cancer Stage II
Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage…
- Trial name
- ACNTBC (NCT05558722)
- Testing
- Anlotinib
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Xijing Hospital
Estrogen Receptor Negative, Estrogen Receptor Positive
Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer
This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane) in treating patients with triple-negative or…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT02648477
- Testing
- Anastrozole, Doxorubicin Hydrochloride, Exemestane
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- City of Hope Medical Center
Breast Cancer
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine…
- Trial name
- NCT05104866
- Testing
- Dato-DXd, Capecitabine, Gemcitabine
- Where
- 167 sites in United States, Argentina and 18 more
- Volunteers
- 732 people
- Sponsor
- AstraZeneca
Hormone Receptor Positive Breast Cancer
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2…
- Trial name
- BOLERO-4 (NCT01698918)
- Testing
- Everolimus, Letrozole, Exemestane
- Where
- 52 sites in United States, Argentina and 11 more
- Volunteers
- 202 people
- Sponsor
- Novartis Pharmaceuticals
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer
This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer.
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage I Breast Cancer
- Trial name
- NCT00194792
- Testing
- exemestane, triptorelin pamoate, capecitabine
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Washington
Breast Cancer, Triple Negative Breast Cancer
Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.
The study consists of 2 parts: a retrospective study, and a prospective clinical study with pembrolizumab (Keytruda®) (Phase 0). 1.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Negative Neoplasm
- Trial name
- NCT03197389
- Testing
- Pembrolizumab
- Where
- Belgium
- Volunteers
- 54 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven