Clinical trials: Hormone Receptor Positive, HER2 Negative Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- ELEMENT (NCT06201234)
- Testing
- Olaparib + Elacestrant, Olaparib
- Where
- 36 sites in Germany
- Volunteers
- 176 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Breast Neoplasm, Breast Cancer
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for…
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC)
- Trial name
- FASCINATE-N (NCT05582499)
- Testing
- Dalpiciclib, Pyrotinib, SHR-A1811
- Where
- China
- Volunteers
- 716 people
- Sponsor
- Fudan University
Metastatic Breast Cancer, Triple Negative Breast Cancer
Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer
This is a Phase I study to test the safety of a combination of ASTX727 with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Tumor
- Trial name
- NCT04134884
- Testing
- Talazoparib, ASTX727
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- Kathy Miller
Breast Cancer, Small Cell Lung Cancer
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity…
- Conditions
- Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT06257264
- Testing
- BG-68501, Fulvestrant, BGB-43395
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- BeiGene
Breast Cancer
A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer(Overstep)
A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
- Trial name
- NCT02597868
- Testing
- Capecitabine, endocrine therapy
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Zhejiang Cancer Hospital
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
Breast Cancer
Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC
The main hypothesis of the study is that enzalutamide induces a significant proliferative arrest in HR+/HER2-negative breast cancer falling into the PAM50 HER2-E subtype.
- Trial name
- ARIANNA (NCT04142060)
- Testing
- Enzalutamide
- Where
- 8 sites in Spain
- Volunteers
- 34 people
- Sponsor
- SOLTI Breast Cancer Research Group
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
Breast Cancer
Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score
The purpose of this study is to see whether adding everolimus to hormone treatment before breast surgery will increase the chances of shrinking the breast cancer in those patients with hormone-responsive breast cancer and a lower…
- Trial name
- NCT02236572
- Testing
- Everolimus
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Yale University
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in…
- Conditions
- Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma
- Trial name
- NCT01272037
- Testing
- Anastrozole, Exemestane, Laboratory Biomarker Analysis
- Where
- 1,568 sites in United States, Canada and 8 more
- Volunteers
- 5,018 people
- Sponsor
- National Cancer Institute (NCI)
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
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.
- Trial name
- NCT03703466
- Testing
- Abemaciclib
- Where
- 15 sites in Australia, Belgium and 3 more
- Volunteers
- 72 people
- Sponsor
- Eli Lilly and Company
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
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer.
- Trial name
- OVELIA (NCT04906395)
- Testing
- TOL2506, Tamoxifen, Letrozole Tablets
- Where
- 59 sites in United States, Argentina and 5 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
ER+ Breast Cancer
Circulating Tumor DNA
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial.
- Trial name
- NCT06923527
- Testing
- Elacestrant
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Breast Cancer
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
This is a multi-center, two-cohorts, phase IIIb study of Capivasertib+Fulvestrant in HR+/HER2-ABC who had disease recurrence/progression following 1-2L endocrine therapy.
- Trial name
- CAPItrue (NCT06635447)
- Testing
- Capivasertib, Fulvestrant
- Where
- 76 sites in China
- Volunteers
- 293 people
- Sponsor
- AstraZeneca
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Breast Cancer
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the…
- Trial name
- NCT01857193
- Testing
- ribociclib (LEE011), Exemestane, Everolimus (RAD001)
- Where
- 13 sites in United States, Belgium and 3 more
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal…
- Trial name
- SOLAR-1 (NCT02437318)
- Testing
- Fulvestrant, Alpelisib
- Where
- 197 sites in United States, Argentina and 29 more
- Volunteers
- 572 people
- Sponsor
- Novartis Pharmaceuticals