Clinical trials: Hormone Receptor Positive, HER2 Negative Breast Cancer
Breast Cancer, HER2-negative Breast Cancer
CLEAR-B: Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer
This is a non-interventional retrospective cohort study of premenopausal patients with HR+/HER2- breast cancer who are treated in the adjuvant setting with either Tamoxifen, Tamoxifen + Ovarial Function Suppression or Aromatase…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- CLEAR-B (NCT05870813)
- Where
- Germany
- Volunteers
- 3,000 people
- Sponsor
- Institut fuer Frauengesundheit
Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer
This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body.
- Conditions
- Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03477396
- Testing
- Aromatase Inhibitor, Laboratory Biomarker Analysis, Pharmacokinetic Study
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- City of Hope Medical Center
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06525766
- Testing
- Biospecimen Collection, Bone Scan, Capecitabine
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Breast Neoplasm Female, Therapeutics
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise…
- Conditions
- Breast Neoplasm Female, Therapeutics, Mutation
- Trial name
- NCT03786575
- Testing
- Next Generation Sequencing (NGS) detection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking Union Medical College
Breast Cancer
Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer
HR+/HER2-negative BC represent ∼70% of all newly diagnosed breast tumours and are responsible for most recurrences and deaths due to this disease, and despite available standard therapies, ∼15-20% of hormone tumours recur at…
- Trial name
- NEREA (NCT04460430)
- Testing
- Neratinib + endocrine therapy
- Where
- 15 sites in Portugal, Spain
- Volunteers
- 12 people
- Sponsor
- SOLTI Breast Cancer Research Group
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive
- Trial name
- NCT03723928
- Testing
- Usual care disease monitoring, Serum Tumor Marker directed disease monitoring, Quality-of-Life Assessment
- Where
- 723 sites in United States, Guam and 1 more
- Volunteers
- 739 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer, Cancer of Breast
MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer
In patients with locally advanced hormone receptor positive (HR+)/HER2- breast cancer, neoadjuvant chemotherapy produces a pathologic complete response rate (pCR) of only 9-15%, and late recurrences often occur despite…
- Trial name
- NCT03285607
- Testing
- MCS110, Doxorubicin, Cyclophosphamide
- Sponsor
- Washington University School of Medicine
Breast Cancer Female, Hormone Receptor Positive Malignant Neoplasm of Breast
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone…
- Trial name
- NCT03969121
- Testing
- Palbociclib, Endocrine therapy
- Where
- 25 sites in Australia, Hong Kong and 3 more
- Volunteers
- 141 people
- Sponsor
- Kyoto Breast Cancer Research Network
Breast Cancer, Cancer
A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy
Endocrine therapy is the initial treatment for most hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancers.
- Trial name
- NCT04274933
- Testing
- Venetoclax, Capecitabine
- Where
- 18 sites in United States, Germany and 2 more
- Volunteers
- 4 people
- Sponsor
- AbbVie
Breast Cancer, Hormone Receptor-positive Breast Cancer
VS-6766+Abema+Fulv in Met HR+/HER- BC
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer.
- Conditions
- Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT05608252
- Testing
- VS-6766, Abemaciclib, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Adrienne G. Waks
Breast Cancer
Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women
This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive…
- Trial name
- PEARL (NCT02028364)
- Testing
- Everolimus, Exemestane
- Where
- 5 sites in Belgium
- Volunteers
- 55 people
- Sponsor
- Jules Bordet Institute
Metastatic Breast Cancer
Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype
HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is…
- Trial name
- HARMONIA (NCT05207709)
- Testing
- Ribociclib + Letrozole OR Fulvestrant, Palbociclib + Letrozole OR Fulvestrant, Paclitaxel +/- Tislelizumab
- Where
- 71 sites in United States, Portugal and 1 more
- Volunteers
- 61 people
- Sponsor
- SOLTI Breast Cancer Research Group
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Breast Cancer Stage IV
Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.
A assessment of the efficacy of first-/second-line endocrine therapies ± target therapies and chemotherapy in real-life of in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer has not yet been…
- Trial name
- NCT04852081
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- Russia
- Volunteers
- 1,000 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Estrogen Receptor Negative, Estrogen Receptor Positive
Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer
This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane) in treating patients with triple-negative or…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT02648477
- Testing
- Anastrozole, Doxorubicin Hydrochloride, Exemestane
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- City of Hope Medical Center
HER2 Negative Breast Cancer Not Immediately Operated
Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS)
Women aged 70 years or older, newly diagnosed for locally advanced unilateral breast cancer, with a histological diagnosis of invasive mammary carcinoma, positive hormone receptors, HER2 status Negative, not immediately operable…
- Trial name
- CALHYS (NCT05664893)
- Testing
- Ribociclib Oral Tablet
- Where
- France
- Sponsor
- Centre Antoine Lacassagne
Breast Cancer, Early Stage
Ablation Compare With Surgery for Early Breast Cancer
Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance.
- Conditions
- Breast Cancer, Early Stage, Hormone Receptor Positive, Ablation
- Trial name
- NCT07484087
- Testing
- breast conserving surgery, cryo-thermal ablation
- Where
- China
- Volunteers
- 264 people
- Sponsor
- Peking University People's Hospital
Advanced Breast Cancer
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as…
- Trial name
- EvoPAR-BR01 (NCT06380751)
- Testing
- Saruparib (AZD5305), Camizestrant, Abemaciclib
- Where
- 306 sites in United States, Argentina and 27 more
- Volunteers
- 788 people
- Sponsor
- AstraZeneca
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Cancer of the Breast
Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing
Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging.
- Trial name
- NCT04968964
- Testing
- DiviTum® TKa assay, Study Care Plans
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Washington University School of Medicine