Clinical trials: Hormone Receptor Positive Breast Cancer, active
Breast Cancer
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).
- Trial name
- NCT01872260
- Testing
- LEE011, Letrozole, BYL719
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 259 people
- Sponsor
- Novartis Pharmaceuticals
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
Hormone Receptor-Positive Breast Cancer
Estradiol Levels According to Body Mass Index in Premenopausal Patients With Breast Cancer
his prospective observational study will evaluate whether body mass index (BMI) is associated with serum estradiol levels in premenopausal women with hormone receptor-positive breast cancer.
- Trial name
- SIMPEC-E2 (NCT07833501)
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- D'Or Institute for Research and Education
Metastatic Urothelial Carcinoma, Breast Cancer
Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC
This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.
- Conditions
- Metastatic Urothelial Carcinoma, Breast Cancer, TNBC - Triple-Negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT07671092
- Testing
- RYZ211/212
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 40 people
- Sponsor
- RayzeBio, Inc.
Breast Cancer
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
- Trial name
- TB06 (NCT07205822)
- Testing
- Dato-DXd
- Where
- 40 sites in United States, China and 4 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer
Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.
The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in…
- Trial name
- NELOPHER (NCT07394946)
- Testing
- Letrozole
- Where
- Pakistan
- Volunteers
- 126 people
- Sponsor
- Cancer Care Hospital & Research Centre Foundation, Lahore
Lobular Breast Carcinoma
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
The NAPOLI Study is a retrospective multicenter observational study designed to characterize hormone receptor-negative/low invasive lobular carcinoma of the breast.
- Trial name
- NAPOLI (NCT07613151)
- Testing
- Upfront Breast Surgery, Adjuvant Radiotherapy, Endocrine Therapy
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Istituto Oncologico Veneto IRCCS
Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer
Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole
This is a phase II study testing the combination of Pembrolizumab with Lenvatinib, a multi-kinase inhibitor that has activity against vascular endothelial growth factor receptors 1-3 (VEGFR1-3), fibroblast growth factor receptors…
- Trial name
- LaPemERLA (NCT05286437)
- Testing
- Oral Lenvatinib + Intravenous (IV) Pembrolizumab + Oral Letrozole
- Where
- Singapore
- Volunteers
- 40 people
- Sponsor
- National Cancer Centre, Singapore
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
Breast Cancer
Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer
This study is an observational study being carried out in several hospitals. No extra tests or procedures are required beyond those already part of normal medical care.
- Trial name
- PAMBRACA (NCT07617025)
- Where
- 6 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Angela Toss
Breast Cancer
Breast Cancer Index (BCI) Registry
The purpose of the Breast Cancer Index (BCI) Registry study is to conduct a large scale, population-based prospective registry to evaluate long-term clinical outcome, clinical impact, medication adherence and quality of life in…
- Trial name
- NCT04875351
- Testing
- Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test
- Where
- 105 sites in United States
- Volunteers
- 3,465 people
- Sponsor
- Biotheranostics, Inc.
Breast Cancer, HER 2 Negative Breast Cancer
Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer
The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment.
- Conditions
- Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, Stage 1-3
- Trial name
- NCT07102940
- Testing
- Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v), Dose dense Adriamycin-cyclophosphamide (AC) i.v
- Volunteers
- 50 people
- Sponsor
- George Washington University
Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC)
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors…
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer
- Trial name
- NCT07020117
- Testing
- [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
- Where
- 14 sites in United States
- Volunteers
- 150 people
- Sponsor
- Aktis Oncology, Inc.
Breast Cancer
Long Term Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women
This study evaluates the long-term effects of adding 2 years of ovarian function suppression (OFS) to tamoxifen therapy in young premenopausal women with hormone receptor-positive breast cancer after chemotherapy.
- Trial name
- ASTRRAIV (NCT07735897)
- Where
- South Korea
- Volunteers
- 1,483 people
- Sponsor
- MedicalExcellence
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the…
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07391774
- Testing
- Anastrozole, Biospecimen Collection, Bone Scan
- Where
- 258 sites in United States, Puerto Rico
- Volunteers
- 1,978 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer Recurrent
Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer
POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer.
- Trial name
- POLAR (NCT03820830)
- Testing
- Palbociclib 125mg, Standard endocrine therapy
- Where
- 53 sites in Austria, France and 4 more
- Volunteers
- 405 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer, Advanced HR+/HER2- Breast Cancer
Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable…
- Conditions
- Breast Cancer, Advanced HR+/HER2- Breast Cancer, Advanced Triple-Negative Breast Cancer
- Trial name
- SATROPIN (NCT07367178)
- Testing
- Sacituzumab Govitecan (SG), Atropine, G-CSF (Granulocyte colony-stimulating factor)
- Volunteers
- 30 people
- Sponsor
- MedSIR
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
- Trial name
- MAPPER (NCT06361940)
- Testing
- Aromatase inhibitors or tamoxifen
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- Medical College of Wisconsin
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
This study is being done to learn more about breast cancer patients' experiences with sleep changes during cancer treatment, identify possible reasons for poor sleep quality, and to find out how stress, social support, and living…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma
- Trial name
- NCT07341503
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Ohio State University Comprehensive Cancer Center