Clinical trials: HR+ Metastatic Breast Cancer
Breast Cancer
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of…
- Trial name
- NCT04460911
- Where
- United States
- Volunteers
- 317 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine…
- Trial name
- NCT05104866
- Testing
- Dato-DXd, Capecitabine, Gemcitabine
- Where
- 167 sites in United States, Argentina and 18 more
- Volunteers
- 732 people
- Sponsor
- AstraZeneca
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
Breast Cancer
Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy
The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line…
- Trial name
- NCT04394247
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Pfizer
Breast Cancer
HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes
This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as…
- Trial name
- NCT04396626
- Where
- United States
- Volunteers
- 975 people
- Sponsor
- Pfizer
Breast Cancer
Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in other research studies and laboratory experiments.
- Trial name
- NCT01560416
- Testing
- Fulvestrant, Ganetespib
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Dana-Farber Cancer Institute
Metastatic Breast Cancer, Breast Carcinoma
Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer
This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor…
- Trial name
- MAINTAIN (NCT02632045)
- Testing
- LEE-011, Fulvestrant
- Where
- 13 sites in United States
- Volunteers
- 169 people
- Sponsor
- Melissa K Accordino
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
UK Ibrance Patient Program (IPP) Study
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients…
- Trial name
- ROIS (NCT03921866)
- Testing
- Palbociclib
- Where
- 8 sites in United Kingdom
- Volunteers
- 191 people
- Sponsor
- Pfizer
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after…
- Trial name
- NCT01528345
- Testing
- Dovitinib, Fulvestrant
- Where
- 67 sites in United States, Argentina and 13 more
- Volunteers
- 97 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy…
- Trial name
- NCT06086340
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 779 people
- Sponsor
- Pfizer
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Breast Neoplasm, Neoplasm Metastasis
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred…
- Trial name
- postMONARCH (NCT05169567)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 138 sites in United States, Argentina and 15 more
- Volunteers
- 368 people
- Sponsor
- Eli Lilly and Company
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive…
- Trial name
- SUMMIT (NCT01953926)
- Testing
- Neratinib, Fulvestrant, Trastuzumab
- Where
- 60 sites in United States, Australia and 11 more
- Volunteers
- 582 people
- Sponsor
- Puma Biotechnology, Inc.
Estrogen Receptor Negative, Estrogen Receptor Positive
Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer
This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane) in treating patients with triple-negative or…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT02648477
- Testing
- Anastrozole, Doxorubicin Hydrochloride, Exemestane
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- City of Hope Medical Center
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth…
- Trial name
- NCT05452798
- Where
- Denmark
- Volunteers
- 1,054 people
- Sponsor
- Pfizer
Breast Cancer Metastatic
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination…
- Trial name
- NCT05155566
- Where
- 2 sites in Argentina, United Kingdom
- Volunteers
- 847 people
- Sponsor
- Pfizer