Clinical trials: HER2-negative Metastatic Breast Cancer
Breast Cancer
Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor
Based on the results of the phase Ib/II study, the investigators hypothesize that combining a RET inhibitor lenvatinib with endocrine therapy letrozole improves objective response and progression-free survival compared to…
- Trial name
- NCT05181033
- Testing
- Lenvatinib + Letrozole, Fulvestrant
- Where
- Singapore
- Volunteers
- 120 people
- Sponsor
- National University Hospital, Singapore
Hormonal Receptors Positive, HER2 Negative, Advanced Breast Cancer
Prediction of Treatment Efficacy of the Combination of Palbociclib/(Letrozole or Anastrozole) in First Line Metastatic Women With Luminal, HER2 Negative Advanced Breast Cancer, Using Infrared Laser Spectroscopy Analysis on Liquid Biopsies.
This study is a multicenter, international, open-label phase II study. Based on inclusion/exclusion criteria, eligible pre and postmenopausal patients with newly diagnosed metastatic luminal hormone receptor-positive and HER2…
- Trial name
- ICRG0201 (NCT05190094)
- Testing
- Combination of Palbociclib and aromatase inhibitor (Letrozole or Anastrozole)
- Where
- 7 sites in Algeria, Jordan and 1 more
- Volunteers
- 80 people
- Sponsor
- International Cancer Research Group, United Arab Emirates
HER2-negative Breast Cancer, Hormone Receptor Positive Tumor
A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer
The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients…
- Conditions
- HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT07227831
- Testing
- TheraBionic P1
- Where
- 8 sites in United States
- Volunteers
- 82 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer
This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab or pembrolizumab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer and…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, HR+ / HER2- Advanced Breast Cancer
- Trial name
- NCT05318469
- Testing
- Ivermectin, Balstilmab, Pembrolizumab
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Yuan Yuan
Breast Cancer, Estrogen Receptor-positive Breast Cancer
Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)
A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.
- Conditions
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, Metastatic Breast Cancer
- Trial name
- B-001 (NCT04571437)
- Testing
- Capecitabine, Letrozole 2.5mg
- Where
- Egypt
- Volunteers
- 204 people
- Sponsor
- Cairo University
Metastatic Breast Cancer
PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)
This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of PQR309 in combination with standard dose of…
- Trial name
- NCT02723877
- Testing
- PQR309, Eribulin
- Where
- 5 sites in Spain, United Kingdom
- Volunteers
- 41 people
- Sponsor
- PIQUR Therapeutics AG
Breast Cancer
DiEtary Mimicry by Glucocorticoid Modulation Evaluation in ER+ Metastatic Breast Cancer Treatment: Efficacy and Response (DEMETER Trial)
This is a single centre, open label, phase II clinical study consisting of two parts, each consisting of a different dose of the same intervention to investigate the efficacy of dexamethasone as an adjunct to endocrine therapy in…
- Trial name
- DEMETER (NCT07786051)
- Testing
- Dexamethasone (Oral)
- Volunteers
- 80 people
- Sponsor
- The Netherlands Cancer Institute
Breast Cancer
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative…
- Trial name
- NCT04807595
- Testing
- None (Observational study)
- Where
- 13 sites in United States, Australia and 8 more
- Volunteers
- 798 people
- Sponsor
- AstraZeneca
Breast Adenocarcinoma, Breast Cancer Stage IV
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET.
- Conditions
- Breast Adenocarcinoma, Breast Cancer Stage IV, Breast Cancer, Metastatic, Breast Carcinoma
- Trial name
- PALMARES-2 (NCT06805812)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 24 sites in Italy
- Volunteers
- 3,500 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Breast Cancer, Hormone Receptor Positive Tumor
Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line
This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, HER 2 Negative Breast Cancer
- Trial name
- RIBBIT (NCT03462251)
- Testing
- Ribociclib and aromatase inhibitor or fulvestrant, Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab
- Where
- 27 sites in Germany
- Volunteers
- 41 people
- Sponsor
- iOMEDICO AG
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
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 I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer
This phase I/II trial studies the side effects and best dose of hydroxychloroquine when given together with palbociclib and letrozole before surgery in treating patients with estrogen receptor positive, HER2 negative breast…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT03774472
- Testing
- Hydroxychloroquine, Letrozole, Palbociclib
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, Metastatic Breast Cancer
Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer
The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.
- Trial name
- NCT00148707
- Testing
- CT-2103 (Xyotax)
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Dana-Farber Cancer Institute
Estrogen Receptor Positive, HER2/Neu Negative
Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer
This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Invasive Breast Carcinoma, Multifocal Breast Carcinoma
- Trial name
- NCT03128619
- Testing
- Biopsy of Breast, Copanlisib, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Breast Cancer
Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
- Trial name
- NCT03393845
- Testing
- Pembrolizumab, Fulvestrant
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- Nancy Chan, MD
Breast Cancer
NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer
This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: Nivolumab (Opdivo ®) Ipilimumab (Yervoy ®)
- Trial name
- NCT03789110
- Testing
- Nivolumab, Ipilimumab
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination.
- Trial name
- NCT02023359
- Testing
- Everolimus and exemestane
- Where
- 3 sites in Denmark
- Volunteers
- 7 people
- Sponsor
- Novartis Healthcare A/S
Metastatic Breast Cancer
Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer
This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free survival in metastatic breast…
- Trial name
- PROCEED (NCT01501669)
- Testing
- Irinotecan, Capecitabine
- Where
- South Korea
- Volunteers
- 222 people
- Sponsor
- National Cancer Center, Korea
Triple -Negative Breast Cancer, Estrogen Receptor Negative
Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer
This pilot trial studies how well chemokine modulation therapy works when given prior to pembrolizumab in treating participants with triple-negative breast cancer that has spread to other places in the body.
- Conditions
- Triple -Negative Breast Cancer, Estrogen Receptor Negative, HER2/Neu Negative, Anatomic Stage IV Breast Cancer AJCC
- Trial name
- NCT03599453
- Testing
- Biopsy, Chemokine Modulation Therapy, Celecoxib
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Roswell Park Cancer Institute