Clinical trials: Hormone Receptor Positive Malignant Neoplasm of Breast
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- ELEMENT (NCT06201234)
- Testing
- Olaparib + Elacestrant, Olaparib
- Where
- 36 sites in Germany
- Volunteers
- 176 people
- Sponsor
- GBG Forschungs GmbH
Hormone-receptor Positive Breast Cancer
Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer
This study is being conducted to compare the efficacy and safety of exemestane alone or in combination with pazopanib in postmenopausal women who have hormone receptor positive breast cancer and have failed therapy with…
- Trial name
- NCT00615524
- Testing
- exemestane and pazopanib
- Where
- United States
- Sponsor
- GlaxoSmithKline
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
Hormone Receptor Positive Malignant Neoplasm of Breast
The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population
The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC)…
- Trial name
- NCT02347449
- Testing
- Questionnaires, Oncotype Dx Assay
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- Sunnybrook Health Sciences Centre
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer
This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- NCT04498520
- Testing
- Abexinostat Tosylate, Fulvestrant, Palbociclib
- Sponsor
- Pamela Munster
Metastatic or Locally-advanced Unresectable Breast Cancer
BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer
The purpose of this study is to test the safety of a drug called BYL719 at different dose levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the patient and breast cancer.
- Trial name
- NCT01870505
- Testing
- BYL719, Letrozole, Exemestane
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, Hormone Receptor Positive Tumor
Dose EScalation Induction of EvERolimus
The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor; Routine use of everolimus shows an high rate of…
- Trial name
- Desiree (NCT02387099)
- Testing
- 3 weeks Dose Induction of Everolimus, 3 weeks Conventional Everolimus Dosing, Open Label Phase with conventional 10mg Everolimus Dosing week 4-24
- Where
- 14 sites in Germany
- Volunteers
- 156 people
- Sponsor
- GBG Forschungs GmbH
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive, HER2/Neu Positive, Postmenopausal
- Trial name
- NCT02152943
- Testing
- Everolimus, Laboratory Biomarker Analysis, Letrozole
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer Female, HER2-positive Breast Cancer
Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC
This study is a randomized, open-label, phase II study, comparing the efficacy and safety of trastuzumab plus aromatase inhibitors, with or without pyrotinib, in the treatment of HR (hormone receptor)+/HER2 (human epidermal…
- Conditions
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer
- Trial name
- Pyrotinib (NCT03910712)
- Testing
- Pyrotinib, Trastuzumab, Aromatase inhibitor
- Volunteers
- 250 people
- Sponsor
- Peking Union Medical College Hospital
Breast Neoplasms
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone…
- Trial name
- NCT04895358
- Testing
- pembrolizumab, paclitaxel, nab-paclitaxel
- Where
- 256 sites in United States, Argentina and 29 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.
- Trial name
- NCT00293540
- Testing
- oophorectomy, Tamoxifen
- Where
- 21 sites in United States, Bangladesh and 8 more
- Volunteers
- 249 people
- Sponsor
- International Breast Cancer Research Foundation
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer
This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Cutaneous Melanoma, Locally Advanced Mucosal Melanoma
- Trial name
- NCT05098210
- Testing
- Neoantigen Peptide Vaccine, Nivolumab, Poly ICLC
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Fred Hutchinson Cancer Center
Hormone Receptor Positive Malignant Neoplasm of Breast
Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer
The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic…
- Trial name
- NCT02025712
- Testing
- Exemestane, Everolimus
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Organisation for Oncology and Translational Research
Breast Cancer
Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer
The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in breast cancer tumor growth, its ability to spread, and its ability to form new blood vessels.
- Trial name
- NCT01441947
- Testing
- Cabozantinib, Fulvestrant
- Where
- 4 sites in United States
- Volunteers
- 68 people
- Sponsor
- Massachusetts General Hospital
Breast Neoplasm, Breast Cancer
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had…
- Conditions
- Breast Neoplasm, Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- NCT05594095
- Testing
- PIK3CA inhibitor, AKT inhibitor, Carrelizumab
- Where
- China
- Volunteers
- 620 people
- Sponsor
- Fudan University
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
Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
- Trial name
- NCT07612891
- Testing
- INV-6452
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast
Comparison of the Breast Tumor Microenvironment
The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation…
- Trial name
- NCT03165487
- Testing
- Breast tissue collection, Blood sample collection
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Columbia University