Clinical trials: HR+HER2- Advanced Breast Cancer
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
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
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
Hormone Receptor Positive HER-2 Negative Breast Cancer
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer.
- Trial name
- PALINA (NCT02692755)
- Testing
- Palbociclib + Letrozole or Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Georgetown University
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
Advanced Breast Cancer
Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
- Trial name
- TELEPIK (NCT04862143)
- Testing
- Alpelisib, Fulvestrant, Goserelin
- Where
- Sweden
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals
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 of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
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 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
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive…
- Trial name
- BYLieve (NCT03056755)
- Testing
- Alpelisib, Fulvestrant, Letrozole
- Where
- 94 sites in United States, Argentina and 17 more
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
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
Neoplasms
Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior…
- Trial name
- NCT02964507
- Testing
- GSK525762, Fulvestrant
- Where
- 38 sites in United States, Australia and 5 more
- Volunteers
- 124 people
- Sponsor
- GlaxoSmithKline
Breast Cancer, Breast Carcinoma
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors
- Trial name
- NCT05584644
- Testing
- Palbociclib plus hormonal treatment - first line treatment, Palbociclib plus hormonal treatment - second line treatment
- Where
- 6 sites in India
- Volunteers
- 150 people
- Sponsor
- Pfizer
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals