Clinical trials: Hormone Receptor Positive / HER2-negative Breast Cancer
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 Stage I, Breast Cancer Stage II
A Study of the TheraBionic P1 Device in Breast Cancer
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect…
- Conditions
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage IIIA, Hormone Receptor Positive Tumor
- Trial name
- NCT07218432
- Testing
- TheraBionic P1 Device
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Breast Cancer
Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer
RATIONALE: Sunitinib malate and exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Trial name
- NCT00931450
- Testing
- exemestane, sunitinib malate
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Institut Català d'Oncologia
Breast Cancer
A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole.
- Trial name
- VICTORIANE (NCT02730091)
- Testing
- Letrozole, Anastrozole, Vinorelbine
- Where
- France
- Volunteers
- 98 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Breast Cancer Metastatic
Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves…
- Trial name
- NCT07137871
- Testing
- Avasopasem
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal hormone receptor-positive (HR+)…
- Trial name
- TATEN (NCT04251169)
- Testing
- Pembrolizumab, Paclitaxel
- Where
- 7 sites in Spain
- Volunteers
- 20 people
- Sponsor
- SOLTI Breast Cancer Research Group
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.
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer: Arm A: concomitant cyclin-dependent Kinase 4/6…
- Conditions
- Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- KENDO (NCT03227328)
- Testing
- concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy, chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)
- Where
- 20 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
Invasive Breast Cancer, Metastatic Breast Cancer
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer.
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT04448886
- Testing
- Pembrolizumab, Sacituzumab Govitecan
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Ana C Garrido-Castro, MD
HER2-positive Breast Cancer, Male Breast Cancer
Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer
This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT01729884
- Testing
- HER-2/neu peptide vaccine
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Washington
Breast Cancer
Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer
Pfizer's innovative drug palbociclib (trade name: Ibrance®) got China National Drug Administration (CNDA) approval on July 31, 2018.
- Trial name
- NCT04047758
- Testing
- Palbociclib + Letrozole, Letrozole
- Where
- 3 sites in China
- Volunteers
- 420 people
- Sponsor
- Shengjing Hospital
Breast Cancer Stage III, Breast Cancer Stage II
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
- Trial name
- NCT06810492
- Testing
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Volunteers
- 40 people
- Sponsor
- Hongmei Zheng, PhD
Breast Cancer, Estrogen Receptor Positive Tumor
Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure
This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor).
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, Menopause, Hormone Antagonist
- Trial name
- ULTIMATE (NCT02997995)
- Testing
- Immune-attractant, Durvalumab, Biopsy
- Where
- 29 sites in France, Spain and 1 more
- Volunteers
- 61 people
- Sponsor
- UNICANCER
Breast Cancer
Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer
ONAWA is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of onapristone (ONA) on proliferation after 3 weeks of treatment in postmenopausal women with ER+/PgR+ and HER2-negative early…
- Trial name
- ONAWA (NCT04142892)
- Testing
- Onapristone
- Where
- 4 sites in Spain
- Volunteers
- 10 people
- Sponsor
- SOLTI Breast Cancer Research Group
Hormone Receptor Positive HER-2 Negative Breast Cancer
Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors…
- Trial name
- NCT05878314
- Where
- Germany
- Volunteers
- 504 people
- Sponsor
- University Hospital Tuebingen
Advanced or Metastatic Breast Cancer
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast…
- Trial name
- DB-06 (NCT04494425)
- Testing
- Trastuzumab deruxtecan, Capecitabine, Paclitaxel
- Where
- 293 sites in United States, Argentina and 26 more
- Volunteers
- 866 people
- Sponsor
- AstraZeneca