Clinical trials: Hormone Receptor Positive HER-2 Negative Breast Cancer
Breast Cancer, Metastatic Breast Cancer
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- OASIS (NCT04720664)
- Testing
- SM-88
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Breast Cancer, Metastatic Breast Cancer
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05524584
- Testing
- Fulvestrant, Anastrozole, Abemaciclib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Irvine
Breast Cancer
Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer
This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer…
- Trial name
- PIKTAM (NCT02404844)
- Testing
- BKM120, Tamoxifen
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- University Hospital, Essen
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer.
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer
- Trial name
- NCT01791478
- Testing
- PI3K inhibitor BYL719, letrozole, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
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.
Hormone Receptor Positive HER-2 Negative Breast Cancer
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer.
- Trial name
- PALINA (NCT02692755)
- Testing
- Palbociclib + Letrozole or Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Georgetown University
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
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast…
- Trial name
- EarLEE-1 (NCT03078751)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Where
- 33 sites in United States
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Hormone Receptor Positive Tumor
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma
- Trial name
- neoMONARCH (NCT02441946)
- Testing
- Abemaciclib, Loperamide, Anastrozole
- Where
- 66 sites in United States, Austria and 8 more
- Volunteers
- 224 people
- Sponsor
- Eli Lilly and Company
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant.
- Trial name
- NCT03481998
- Testing
- SHR6390, Letrozole or anastrozole or Fulvestrant
- Where
- 4 sites in China
- Volunteers
- 104 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery.
- Trial name
- NCT02520063
- Testing
- Letrozole, Everolimus, TRC105
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Alabama at Birmingham
Estrogen Receptor Positive, HER2/Neu Negative
Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer
This randomized phase II trial studies the side effects and how well fulvestrant and palbociclib with or without copanlisib work in treating patients with hormone receptor positive, HER2 negative, stage IV breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03377101
- Testing
- Copanlisib, Fulvestrant, Laboratory Biomarker Analysis
- Sponsor
- National Cancer Institute (NCI)
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
HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer, HER2-negative Circulating Tumor Cells
DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
Several studies have indicated that determining prevalence and number of circulating tumor cells (CTCs) at various time points during treatment may be an effective tool for assessing treatment efficacy in metastatic breast cancer…
- Conditions
- HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer, HER2-negative Circulating Tumor Cells, Postmenopausal Female Patients
- Trial name
- NCT02035813
- Testing
- Ribociclib, Eribulin
- Where
- Germany
- Volunteers
- 116 people
- Sponsor
- Prof. Wolfgang Janni
Advanced Breast Cancer
Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor…
- Trial name
- ITHRAN (NCT07180160)
- Testing
- QL1706, CDK4/6 inhibitor, Fulvestrant
- Where
- China
- Volunteers
- 123 people
- Sponsor
- Wenjin Yin
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative
- Trial name
- NCT02115282
- Testing
- Biospecimen Collection, Computed Tomography, Entinostat
- Where
- 653 sites in United States, South Africa
- Volunteers
- 608 people
- Sponsor
- National Cancer Institute (NCI)
Hormone Receptor Positive HER-2 Negative Breast Cancer
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care.
- Trial name
- NCT07459738
- Testing
- HLX43
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer, Breast Neoplasms
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk…
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancers
- Trial name
- TRIM-EBC (NCT06517212)
- Testing
- Tirzepatide
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Baylor Research Institute