Clinical trials: Hormone Receptor Positive Advanced Breast Cancer
Breast Cancer
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: HR-positive…
- Trial name
- FourLight-3 (NCT06760637)
- Testing
- PF-07220060, letrozole, abemaciclib
- Where
- 460 sites in United States, Argentina and 28 more
- Volunteers
- 1,035 people
- Sponsor
- Pfizer
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ERW316 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 ERW316 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 (mCRPC)
- Trial name
- NCT07570966
- Testing
- ERW316, Fulvestrant, Letrozole
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer
HR+/HER2-negative BC represent ∼70% of all newly diagnosed breast tumours and are responsible for most recurrences and deaths due to this disease, and despite available standard therapies, ∼15-20% of hormone tumours recur at…
- Trial name
- NEREA (NCT04460430)
- Testing
- Neratinib + endocrine therapy
- Where
- 15 sites in Portugal, Spain
- Volunteers
- 12 people
- Sponsor
- SOLTI Breast Cancer Research Group
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients…
- Trial name
- NCT02333370
- Testing
- LEE011, Letrozole, Tamoxifen
- Where
- 15 sites in Hong Kong, Japan and 1 more
- Volunteers
- 88 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer Metastatic, Advanced Breast Cancer
Safety and Pharmacokinetics of ODM-209
The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
- Conditions
- Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer
- Trial name
- STESIDES (NCT03878823)
- Testing
- ODM-209
- Where
- 4 sites in Denmark, Finland and 1 more
- Volunteers
- 38 people
- Sponsor
- Orion Corporation, Orion Pharma
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
This is an open-label, single-arm, phase I trial. It is designed with a conservative dose escalation plan to ensure patient's safety and with a strong translational component to inform if target inhibition is achieved.
- Conditions
- Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor Positive Breast Cancer
- Trial name
- NCT03854903
- Testing
- Palbociclib, Bosutinib, Fulvestrant
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Georgetown University
Breast Cancer
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..
- Trial name
- ZACFAST (NCT00752986)
- Testing
- ZD6474 (Vandetanib at the dose of 100 mg), Fulvestrant, ZD6474 (Vandetanib at the dose of 300 mg)
- Where
- 11 sites in Italy
- Volunteers
- 39 people
- Sponsor
- Genzyme, a Sanofi Company
Advanced Breast Cancer
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as…
- Trial name
- EvoPAR-BR01 (NCT06380751)
- Testing
- Saruparib (AZD5305), Camizestrant, Abemaciclib
- Where
- 306 sites in United States, Argentina and 27 more
- Volunteers
- 788 people
- Sponsor
- AstraZeneca
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.
Non Small Cell Lung Cancer, Cervical Cancer
Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with…
- Conditions
- Non Small Cell Lung Cancer, Cervical Cancer, SCCHN, Pancreatic Cancer
- Trial name
- NCT04925284
- Testing
- XB002, Nivolumab, Bevacizumab
- Where
- 95 sites in United States, Australia and 7 more
- Volunteers
- 269 people
- Sponsor
- Exelixis
Breast Cancer
Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy
The purpose of this study is to determine if the triplet combination of dalpiciclib, fulvestrant, and pyrotinib is safe and effective in the treatment of hormone receptor-positive, HER2-low locally advanced/metastatic breast…
- Trial name
- NCT05806671
- Testing
- Dalpiciclib, Pyrotinib, Fulvestrant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Neoplasm Female
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer
Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line…
- Trial name
- NCT03425838
- Testing
- CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor, Fulvestrant
- Where
- 72 sites in Netherlands
- Volunteers
- 1,050 people
- Sponsor
- Borstkanker Onderzoek Groep
Solid Tumor, Advanced Solid Tumor
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for…
- Conditions
- Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult, Metastatic Tumor
- Trial name
- NCT06586957
- Testing
- NKT3964, Paclitaxel, Doxorubicin
- Where
- 20 sites in United States, South Korea
- Volunteers
- 238 people
- Sponsor
- NiKang Therapeutics, Inc.
Advanced Breast Cancer
Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor
Protocol Title: A Phase II open label, umbrella study evaluating the efficacy and safety of Fulvestrant plus DNA damage repair inhibitors in hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor
- Trial name
- Post-CDK (NCT05536128)
- Testing
- Olaparib, Fulvestrant
- Where
- South Korea
- Volunteers
- 64 people
- Sponsor
- Seoul National University Hospital
Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer
A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
- Trial name
- NCT07121244
- Testing
- 68Ga-R11228, 177Lu-R11228
- Where
- 7 sites in United States, Australia
- Volunteers
- 11 people
- Sponsor
- Radionetics Oncology
Hormone Receptor Positive Advanced Breast Cancer
Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC
A retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib plus AI therapy and fulvestrant monotherapy as initial endocrine therapy in the…
- Trial name
- CAPACITY (NCT05000736)
- Testing
- palbociclib + aromatase inhibitor, fulvestrant
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Chinese Academy of Medical Sciences
HR+/HER2- Advanced Breast Cancer, Targeted Therapy
Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer
To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-)…
- Trial name
- NCT05983107
- Testing
- Everolimus, Chidamide, Endocrine therapy
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Neoplasms
A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting
The study is descriptive and aims to characterize the treatment patterns of advanced breast cancer in Poland in the real-world data setting.
- Trial name
- NCT05478590
- Where
- 19 sites in Poland
- Volunteers
- 440 people
- Sponsor
- Pfizer