Clinical trials: Hormone Receptor Negative Breast Carcinoma
Breast Cancer
Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy
PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after…
- Trial name
- PROMETEO II (NCT04130152)
- Testing
- Palbociclib, Letrozole
- Where
- 8 sites in Spain
- Volunteers
- 22 people
- Sponsor
- SOLTI Breast Cancer Research Group
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)
The HERMIONE-7 trial is a phase II, single-arm, open-label, multicenter study in HR+, HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease.
- Trial name
- HERMIONE-7 (NCT04227327)
- Testing
- Abemaciclib, Aromatase Inhibitors
- Where
- 39 sites in Italy
- Volunteers
- 31 people
- Sponsor
- University of Milano Bicocca
Metastatic Breast Cancer
A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer
- Trial name
- NCT02137083
- Testing
- Docetaxel, Fulvestrant
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Fudan University
Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study…
- Conditions
- Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT04683679
- Testing
- Pembrolizumab, Olaparib, Radiation
- Where
- 7 sites in United States
- Volunteers
- 34 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal…
- Trial name
- NCT05304962
- Testing
- RGT-419B, RGT-419B in combination with hormonal therapy
- Where
- 8 sites in United States
- Volunteers
- 64 people
- Sponsor
- Regor Pharmaceuticals Inc.
Breast Cancer, Locoregional Recurrence
Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)
The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone…
- Conditions
- Breast Cancer, Locoregional Recurrence, Abemaciclib, Endocrine Therapy
- Trial name
- AURA (NCT07190443)
- Testing
- Endocrine therapy + Abemaciclib, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Where
- Japan
- Volunteers
- 290 people
- Sponsor
- Japanese Foundation for Cancer Research
Sarcoma, Castrate Resistant Prostate Cancer
A Study of PRT2527 in Participants With Advanced Solid Tumors
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors.
- Conditions
- Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT05159518
- Testing
- PRT2527
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Prelude Therapeutics Incorporated
Breast Cancer
PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1 and 2 HR-positive HER2-negative breast cancer…
- Trial name
- PRIMe (NCT02269813)
- Testing
- MammaPrint, BluePrint, TargetPrint
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 452 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer, Ovarian Cancer
Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in…
- Conditions
- Breast Cancer, Ovarian Cancer, Liposarcoma, Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT05905341
- Testing
- PF-07224826, Fulvestrant
- Sponsor
- Pfizer
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
Metastatic Breast Cancer
A Study of Real-world Outcomes Among Patients Treated With Ribociclib
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative…
- Trial name
- NCT07148505
- Where
- United States
- Volunteers
- 373 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
PALbociclib CoLlaborative Adjuvant Study
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early…
- Trial name
- PALLAS (NCT02513394)
- Testing
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Where
- 437 sites in United States, Australia and 19 more
- Volunteers
- 5,796 people
- Sponsor
- Alliance Foundation Trials, LLC.
Metastatic Breast Cancer
Roll-over Study to Allow Continued Access to Ribociclib
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in…
- Trial name
- NCT05161195
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 73 sites in United States, Argentina and 20 more
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Advanced and/or Metastatic Breast Cancer
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.
- Trial name
- NCT05044988
- Testing
- HS-10342
- Volunteers
- 20 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients…
- Trial name
- NCT02333370
- Testing
- LEE011, Letrozole, Tamoxifen
- Where
- 15 sites in Hong Kong, Japan and 1 more
- Volunteers
- 88 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced Breast Cancer, Hormone Receptor Positive，HER2-negative Breast Cancer
Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy
Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early HR+/HER2-breast cancer based on molecular detection
- Trial name
- NCT05809024
- Testing
- letrozole
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Yongsheng Wang
Metastatic Breast Cancer
PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer
This is an open label, randomized, multicenter, international phase II study for premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally advanced breast cancer.
- Trial name
- FATIMA (NCT02917005)
- Testing
- Palbociclib, Exemestane, Goserelin
- Where
- South Africa
- Volunteers
- 160 people
- Sponsor
- Hamdy A. Azim
Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started…
- Trial name
- NCT06463626
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Novartis
Breast Cancer
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Primary objective: Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast…
- Trial name
- SWITCH (NCT01446185)
- Testing
- Oncotype DX breast cancer test
- Where
- 6 sites in France
- Volunteers
- 100 people
- Sponsor
- Genomic Health®, Inc.