Clinical trials: HR+/HER2- Metastatic Breast Cancer
Breast Neoplasms
The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and…
- Trial name
- NCT03659136
- Testing
- Xentuzumab, Everolimus, Exemestane
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- Boehringer Ingelheim
Metastatic Breast Cancer (HR+/ HER2-)
Predicting Endocrine Resistance Using Molecular Imaging and Liquid Biopsy in Metastatic Breast Cancer
This prospective observational study aims to evaluate the prognostic value of molecular imaging biomarkers derived from baseline [18F]FES and [18F]FDG PET/CT for progression-free survival in patients with estrogen receptor…
- Trial name
- NCT07867925
- Testing
- [18F] FES
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Asan Medical Center
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
Melanoma, Renal Cell Carcinoma
A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D.
- Conditions
- Melanoma, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Urothelial Carcinoma
- Trial name
- PIVOT-02 (NCT02983045)
- Testing
- Dose Escalation Doublet: Combination of NKTR-214 + nivolumab, Dose Expansion Doublet: Combination of NKTR-214 + nivolumab, Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- Where
- 58 sites in United States, Belgium and 6 more
- Volunteers
- 557 people
- Sponsor
- Nektar Therapeutics
Breast Cancer
18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Treatment for HR+/HER2- Metastatic Breast Cancer Patients
A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.
- Trial name
- NCT06655545
- Where
- China
- Volunteers
- 473 people
- Sponsor
- Fudan University
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 260 people
- Sponsor
- Pfizer
Breast Cancer Metastatic
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy…
- Trial name
- ABIGAIL (NCT04603183)
- Testing
- Abemaciclib, Paclitaxel, Letrozole
- Where
- 31 sites in Italy, Portugal and 1 more
- Volunteers
- 162 people
- Sponsor
- MedSIR
Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and…
- Conditions
- Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
- Trial name
- NCT03281902
- Testing
- Biopsy, Biospecimen Collection, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Mayo Clinic
Advanced/Metastatic HER2-negative Breast Cancer
Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in…
- Trial name
- NCT06975371
- Testing
- No drug
- Where
- United States
- Volunteers
- 1,415 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasm Female
The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops.
- Trial name
- NCT05075512
- Testing
- anlotinib, fulvestrant
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Zhejiang Cancer Hospital
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Metastatic Breast Cancer
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed.
- Trial name
- NCT05463601
- Testing
- Mecapegfilgrastim, dalpiciclib, exemestane, fulvestrant, letrozole, tamoxifen
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
HR Positive HER2 Negative Advanced Breast Cancer
Iribrine Plus Tucidinostat in the Treatment of HR+/HER2 Advanced Breast Cancer After CDK4/6 Inhibitor Failure
To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer
- Trial name
- NCT05335473
- Testing
- Eribulin and Tucidinostat
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Henan Cancer Hospital
HR+/HER2- Breast Cancer
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole…
- Trial name
- KANDELA-302 (NCT07492641)
- Testing
- BGB-43395, Letrozole, Abemaciclib
- Where
- 241 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Metastatic HR+/HER2- Breast Cancer
Rash & Diarrhea Prophylaxis With Capivasertib
This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone…
- Trial name
- SAFE-CAP (NCT07426822)
- Testing
- Capivasertib, Loperamide, Fulvestrant
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Maryam Lustberg
Advanced HR-positive and HER2-negative Breast Cancer; CDK4/6 Inhibitor Treatment Failed
Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.
This is a single-arm, Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK4/6…
- Trial name
- NCT06133088
- Testing
- dalpiciclib; fluvestrant; compound gossypol acetate tablets
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Zhejiang Cancer Hospital
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor (HR)-Positive Breast Cancer
Palbociclib With Everolimus + Exemestane In BC
This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and…
- Trial name
- NCT02871791
- Testing
- Palbociclib, Everolimus, Exemestane
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Dana-Farber Cancer Institute
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals