Clinical trials: Estrogen-receptor-positive Breast Cancer
Breast Cancer, Invasive Breast Cancer
Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer.
- Conditions
- Breast Cancer, Invasive Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Cancer
- Trial name
- NCT03361800
- Testing
- Entinostat
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Early Breast Cancer
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus…
- Trial name
- NCT04436744
- Testing
- Giredestrant, Anastrozole, Palbociclib
- Where
- 65 sites in United States, Australia and 9 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Breast Cancer Female
Effects of Aromatase Inhibitor Therapy on Muscle Function
This is a pilot study designed to examine changes in muscle function after Aromatase Inhibitor (AI) therapy, at both the molecular and clinical level.
- Trial name
- NCT03581552
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Tarah J Ballinger, MD
Breast Adenocarcinoma, Estrogen Receptor- Negative Breast Cancer
Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen…
- Conditions
- Breast Adenocarcinoma, Estrogen Receptor- Negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative
- Trial name
- NCT02957968
- Testing
- Doxorubicin, Cyclophosphamide, Paclitaxel
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Virginia Commonwealth University
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor (HR)-Positive Breast Cancer
Palbociclib With Everolimus + Exemestane In BC
This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and…
- Trial name
- NCT02871791
- Testing
- Palbociclib, Everolimus, Exemestane
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Dana-Farber Cancer Institute
Estrogen-receptor Positive Invasive Metastatic Breast Cancer
Ruxolitinib in Estrogen Receptor Positive Breast Cancer
This is a Phase II investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in combination with Exemestane in patients with estrogen-receptor positive advanced breast cancer.
- Trial name
- NCT01594216
- Testing
- Ruxolitinib, Exemestane
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Solid Tumors, Ovarian Cancer
Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole
An Open-label Phase 1b Study of ARQ 092 in Combination with other Antineoplastic Agents in Subjects with Selected Solid Tumors
- Conditions
- Solid Tumors, Ovarian Cancer, Endometrial Cancer
- Trial name
- NCT02476955
- Testing
- ARQ 092 + carboplatin + paclitaxel (Closed), ARQ 092 + paclitaxel (Closed), ARQ 092 + anastrozole
- Where
- 5 sites in United States
- Volunteers
- 41 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted
This phase I trial studies talimogene laherparepvec given together with ipilimumab and nivolumab before surgery in patients with triple-negative or estrogen receptor positive, HER2 negative localized breast cancer.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- Trial name
- NCT04185311
- Testing
- Ipilimumab, Nivolumab, Talimogene Laherparepvec
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Breast Cancer
A Study of Ridaforolimus (MK-8669) in Combination With Dalotuzumab (MK-0646) Compared to Standard of Care Treatment in Estrogen Receptor Positive Breast Cancer Patients (MK-8669-041 AM3)
This is a two-part study that will determine, if: 1) the combination of ridaforolimus and dalotuzumab will improve progression-free survival compared to exemestane; and 2) the combination of ridaforolimus and dalotuzumab will…
- Trial name
- NCT01234857
- Testing
- ridaforolimus + dalotuzumab, exemestane, ridaforolimus
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer, Estrogen Receptor-positive Breast Cancer
COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer
This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment…
- Trial name
- Breast 51 (NCT04038489)
- Testing
- Aspirin, Tamoxifen Pill, Doxorubicin
- Where
- United States
- Sponsor
- University of Virginia
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with…
- Trial name
- NCT05306340
- Testing
- Giredestrant, Exemestane, Fulvestrant
- Where
- 136 sites in United States, Argentina and 11 more
- Volunteers
- 373 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS)…
- Trial name
- OFSET (NCT05879926)
- Testing
- Ovarian Function Suppression + Aromatase Inhibitor, Adjuvant Chemotherapy + Ovarian Function Suppression
- Where
- 1,276 sites in United States, Canada and 7 more
- Volunteers
- 3,960 people
- Sponsor
- NRG Oncology
Breast Cancer
SMART-ER: Symptom Monitoring With Patient-reported Outcomes
The key hypothesis for this study is that collection of the PRO surveys via the Outcomes4Me app is feasible, as measured by survey completion rates.
- Trial name
- SMART-ER (NCT05560685)
- Testing
- Outcomes4Me, Semi-structured interview
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Atypical Ductal Hyperplasia, Breast Atypical Lobular Hyperplasia
Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer.
- Conditions
- Breast Atypical Ductal Hyperplasia, Breast Atypical Lobular Hyperplasia, Breast Carcinoma, Breast Ductal Carcinoma In Situ
- Trial name
- NCT06184750
- Testing
- Biopsy Procedure, Biospecimen Collection, Mammography
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast…
- Trial name
- NCT00417885
- Testing
- exemestane, sunitinib malate
- Where
- 3 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- Pfizer
Breast Cancer
Phase II Study of Single Agent Lenvatinib
The Investigators hypothesize that single agent lenvatinib has biological activity in estrogen receptor positive breast cancer, and that the effects are more pronounced in patients with positive RET expression in the tumor.
- Trial name
- NCT03168074
- Testing
- lenvatinib
- Where
- Singapore
- Volunteers
- 30 people
- Sponsor
- National University Hospital, Singapore