Clinical trials: Hormone Receptor Positive, HER2 Negative Breast Cancer
Metastatic Breast Cancer
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
- Trial name
- NCT02792725
- Testing
- Abemaciclib
- Where
- 10 sites in United States
- Sponsor
- Eli Lilly and Company
Advanced HR+/HER2- Breast Cancer
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone…
- Trial name
- NCT07604571
- Testing
- IEV407, Fulvestrant, Letrozole
- Where
- 12 sites in United States, Canada and 7 more
- Volunteers
- 194 people
- Sponsor
- Novartis Pharmaceuticals
Premenopausal Breast Cancer
Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer
This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable locally advanced or metastatic hormonal receptor…
- Trial name
- PEER (NCT02990845)
- Testing
- Pembrolizumab/ Exemestane/ Leuprolide
- Where
- Taiwan
- Volunteers
- 16 people
- Sponsor
- National Taiwan University Hospital
Breast Cancer, Small Cell Lung Cancer
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity…
- Conditions
- Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT06257264
- Testing
- BG-68501, Fulvestrant, BGB-43395
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- BeiGene
Carcinoma, Ductal, Breast, Breast Cancer
G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
- Conditions
- Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
- Trial name
- NCT02983071
- Testing
- G1T38, Fulvestrant
- Where
- 8 sites in Bulgaria, Georgia and 2 more
- Volunteers
- 102 people
- Sponsor
- G1 Therapeutics, Inc.
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
Leucogen, Ribociclib
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2…
- Conditions
- Leucogen, Ribociclib, Neutropenia (Low White Blood Cell Count), Breast Cancer
- Trial name
- NCT07380646
- Testing
- Treat Regimen
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, HER2-positive Breast Cancer
Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer
This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4/6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer, HR+/HER2+ Breast Cancer
- Trial name
- FACET (NCT07716046)
- Testing
- Fulvestaciclib, Trastuzumab, Pertuzumab
- Volunteers
- 240 people
- Sponsor
- Fudan University
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04481113
- Testing
- Abemaciclib, Niraparib Tosylate Monohydrate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- OHSU Knight Cancer Institute
Breast Adenocarcinoma, Breast Cancer Stage IV
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET.
- Conditions
- Breast Adenocarcinoma, Breast Cancer Stage IV, Breast Cancer, Metastatic, Breast Carcinoma
- Trial name
- PALMARES-2 (NCT06805812)
- Testing
- Palbociclib, Ribociclib, Abemaciclib
- Where
- 24 sites in Italy
- Volunteers
- 3,500 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer
Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer
This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic…
- Conditions
- Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer, Metastatic Epithelial Ovarian Cancer
- Trial name
- NCT03294694
- Testing
- Ribociclib, PDR001, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer Stage II
Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage…
- Trial name
- ACNTBC (NCT05558722)
- Testing
- Anlotinib
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Xijing Hospital
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.
- Conditions
- High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- RAINFOL-01 (NCT05579366)
- Testing
- Rina-S, Carboplatin, Bevacizumab
- Where
- 67 sites in United States, China and 2 more
- Volunteers
- 952 people
- Sponsor
- Genmab
Small Cell Lung Cancer, Ovarian Cancer
PF-07104091 as a Single Agent and in Combination Therapy
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with…
- Conditions
- Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04553133
- Testing
- PF-07104091 monotherapy dose escalation, PF-07104091 + palbociclib + fulvestrant, PF-07104091 + palbociclib + letrozole
- Where
- 22 sites in United States, Argentina and 2 more
- Volunteers
- 157 people
- Sponsor
- Pfizer
Breast Cancer
Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy.
- Trial name
- NCT05069038
- Testing
- Palbociclib 125mg
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Nebraska
Breast Cancer
Trastuzumab Deruxtecan Plus ivonescImab for Hormone Receptor-positive HER2 Negative Advanced Breast Cancer Study
The UNITY study is a prospective, single-arm, single-center, Phase II clinical trial conducted by Fudan University Shanghai Cancer Center.
- Trial name
- NCT07647016
- Testing
- Trastuzumab Deruxtecan and ivonescimab
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Fudan University
Breast Cancer, Metastatic Breast Cancer
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- OASIS (NCT04720664)
- Testing
- SM-88
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Metastatic Breast Carcinoma
- Trial name
- ASPIRE (NCT03691493)
- Testing
- Anastrozole, Exemestane, Fulvestrant
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Metastatic Breast Cancer, Triple Negative Breast Cancer
Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer
This is a Phase I study to test the safety of a combination of ASTX727 with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Tumor
- Trial name
- NCT04134884
- Testing
- Talazoparib, ASTX727
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- Kathy Miller
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines