Clinical trials: Hormone Receptor Negative Breast Carcinoma
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
This is a Phase 1/2a open-label, multicenter, dose escalation and dose expansion trial in which IMT-009 will be administered by the intravenous (IV) route to participants with solid tumors or lymphomas.
- Conditions
- Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Squamous Cell Carcinoma
- Trial name
- NCT05565417
- Testing
- IMT-009, Fruquintinib
- Where
- 9 sites in United States
- Volunteers
- 67 people
- Sponsor
- Immunitas Therapeutics
Solid Tumor, Solid Tumor, Adult
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of…
- Conditions
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor
- Trial name
- NCT06264921
- Testing
- NKT3447
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- NiKang Therapeutics, Inc.
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
Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Description of the choices for second line treatment, in the normal clinical practice of the centers adhering to the Hermione Network, in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in…
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
- Trial name
- HERMIONE-13 (NCT05173103)
- Where
- 29 sites in Italy
- Volunteers
- 254 people
- Sponsor
- University of Milano Bicocca
Metastatic Breast Cancer, Drug Resistance
Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd
This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including…
- Conditions
- Metastatic Breast Cancer, Drug Resistance, Hormone Receptor-Positive Breast Cancer, HER2-positive Breast Cancer
- Trial name
- NCT07073755
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hunan Cancer Hospital
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone…
- Trial name
- NCT07061717
- Testing
- Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid, Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid
- Where
- China
- Volunteers
- 474 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer
This phase I/Ib trial tests the safety, side effects, best dose, and effectiveness of ASTX660 (tolinapant) in combination with eribulin mesylate (eribulin) in treating patients with triple negative breast cancer that cannot be…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced HER2-Negative Breast Carcinoma
- Trial name
- NCT06590558
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Sponsor
- National Cancer Institute (NCI)
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer
Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer
This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic…
- Conditions
- Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer, Metastatic Epithelial Ovarian Cancer
- Trial name
- NCT03294694
- Testing
- Ribociclib, PDR001, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Dana-Farber Cancer Institute
Hormone Receptor-positive Metastatic Breast Cancer, HER2-negative Metastatic Breast Cancer
Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management
The MINERVA Trial aims to evaluate safety, efficacy and quality of life (QoL) for the combination of Abemaciclib with an Aromatase Inhibitor or Fulvestrant in pre- and postmenopausal patients with metastatic hormone receptor…
- Trial name
- MINERVA (NCT05362760)
- Testing
- Abemaciclib + Aromatase Inhibitor, Abemaciclib + Fulvestrant
- Where
- 54 sites in Germany, Switzerland
- Volunteers
- 300 people
- Sponsor
- Prof. Wolfgang Janni
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.
Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative)
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
"This is a randomized phase II, two-arm, open label, clinical trial to identify LP-WGS ctDNA biomarker to predict T-DXd response in low-HER2 expressing advanced breast cancer patients compared with endocrine therapy.
- Trial name
- NCT06837792
- Testing
- Experimental treatment arm, Control treatment arm
- Where
- South Korea
- Volunteers
- 141 people
- Sponsor
- Yonsei University
Solid Tumor, TNBC - Triple-Negative Breast Cancer
TH1902 in Patients With Advanced Solid Tumors
Open label first-in-human study of TH1902 in solid cancer, with 4 sequential parts: Part 1 (dose escalation): patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard…
- Conditions
- Solid Tumor, TNBC - Triple-Negative Breast Cancer, Hormone Receptor-positive Breast Cancer, Epithelial Ovarian Cancer
- Trial name
- NCT04706962
- Testing
- TH1902
- Where
- 6 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Theratechnologies
Non Small Cell Lung Cancer, Cervical Cancer
Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with…
- Conditions
- Non Small Cell Lung Cancer, Cervical Cancer, SCCHN, Pancreatic Cancer
- Trial name
- NCT04925284
- Testing
- XB002, Nivolumab, Bevacizumab
- Where
- 95 sites in United States, Australia and 7 more
- Volunteers
- 269 people
- Sponsor
- Exelixis
MSI-H Colorectal Cancer, Melanoma
Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors
This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors.
- Conditions
- MSI-H Colorectal Cancer, Melanoma, Anal Carcinoma, Mesothelioma
- Trial name
- ACROPOLI (NCT04802876)
- Testing
- Spartalizumab, Tislelizumab
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- SOLTI Breast Cancer Research Group
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
Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
This is an open-label, single-arm, phase I trial. It is designed with a conservative dose escalation plan to ensure patient's safety and with a strong translational component to inform if target inhibition is achieved.
- Conditions
- Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor Positive Breast Cancer
- Trial name
- NCT03854903
- Testing
- Palbociclib, Bosutinib, Fulvestrant
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Georgetown University
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
Acute Myeloid Leukemia, Brain Glioblastoma
Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer.
- Conditions
- Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative, Extensive Stage Small Cell Lung Carcinoma
- Trial name
- NCT03154190
- Testing
- Best Practice, Laboratory Biomarker Analysis, Supportive Care
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- Stanford University
Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer
Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer
Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.
- Conditions
- Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- NCT06470672
- Testing
- SHR-A1921, Adebrelimab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Fudan University
Hormone Receptor Positive HER-2 Negative Breast Cancer
A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib
This study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (aBC/mBC) treated with…
- Trial name
- NCT06705504
- Where
- United States
- Volunteers
- 435 people
- Sponsor
- Novartis