Clinical trials: HR+ / HER2- Advanced Breast Cancer
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Breast Cancer
A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.
CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease.
- Trial name
- NCT05770713
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Pfizer
Breast Cancer
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
This study is a national, multicenter, prospective, non-interventional study in women with HR+/HER2- locally advanced or metastatic breast cancer (BC), for which a prior clinical decision to initiate ribociclib + endocrine…
- Trial name
- RosaLEE (NCT05697146)
- Testing
- ribociclib + ET
- Where
- 82 sites in France
- Volunteers
- 1,019 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Advanced or Metastatic Breast Cancer
Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China
This study aims to fill the current gap in data regarding HR+/HER2- ABC 1L treatment patterns and outcomes in the real-world setting in China, especially in the context of the widespread application of CDK4/6is and the lack of…
- Trial name
- NCT07476170
- Where
- China
- Volunteers
- 14,000 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, TNBC - Triple-Negative Breast Cancer
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06568692
- Testing
- PCS6422 and capecitabine, Capecitabine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Processa Pharmaceuticals
Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA
The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms, Neoplasms, Breast, Breast Diseases
- Trial name
- MAGNETIC1 (NCT05814224)
- Testing
- Liquid biopsy and CT scan
- Where
- 7 sites in Italy
- Volunteers
- 164 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
HR-positive,HER2-negative Breast Cancer
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer.
- Trial name
- NCT06705127
- Testing
- TORIPALIMAB INJECTION(JS001 ), Stereotactic Body Radiation Therapy (SBRT)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Locally Advanced Breast Cancer, Intermittent Fasting
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients
Breast cancer is the most common cancer type among women in Egypt and world. Preclinical studies show fasting reduces growth factors and modulates nutrient sensing systems, protecting normal cells against chemotherapy.
- Trial name
- NCT06174259
- Testing
- intermittent fasting
- Where
- Egypt
- Volunteers
- 66 people
- Sponsor
- Menoufia University
Advanced or Metastatic Breast Cancer
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
The study will evaluate the safety, pharmacokinetics, and preliminary activity of GDC-4198 when given in combination with endocrine therapy (ET) (letrozole, fulvestrant, or giredestrant) as first-line treatment to participants…
- Trial name
- FrontROSE (NCT07867262)
- Testing
- GDC-4198, Fulvestrant, Letrozole
- Volunteers
- 165 people
- Sponsor
- Genentech, Inc.
Breast Cancer
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer…
- Trial name
- NCT07648914
- Testing
- BL-B01D1, Albumin-Bound Paclitaxel, Paclitaxel
- Where
- China
- Volunteers
- 446 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
HR+/HER2- Advanced or Metastatic Breast Cancer
A Descriptive Study of Baseline Characteristics, Clinical Outcomes, and Treatment Patterns of HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Alpelisib Plus Fulvestrant Who Have Received Fulvestrant in Any Prior Line of Therapy
This was a non-interventional, retrospective cohort study of patients with HR+/HER2- aBC treated with alpelisib (ALP) plus fulvestrant (FUL) who have received fulvestrant in any prior line of therapy (LoT).
- Trial name
- NCT05853432
- Where
- Ireland
- Volunteers
- 157 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Advanced Breast Cancer, Treatment
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new…
- Conditions
- Advanced Breast Cancer, Treatment, HR Low/HER2 Negative
- Trial name
- NCT06176534
- Testing
- Experimental: chemotheyapy, Active Comparator: endocrine therapy
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer Recurrent, HER2/Neu-negative Carcinoma of Breast
Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
This is a clinical trial with a crossover design to determine patients' preference for capecitabine in combination with bevacizumab or everolimus in combination with exemestane for advanced breast cancer patients and to evaluate…
- Conditions
- Breast Cancer Recurrent, HER2/Neu-negative Carcinoma of Breast, Hormone Receptor Positive Malignant Neoplasm of Breast
- Trial name
- IMPROVE (NCT02248571)
- Testing
- Bevacizumab, Capecitabine, Everolimus
- Where
- Germany
- Volunteers
- 85 people
- Sponsor
- iOMEDICO AG
Breast Cancer Female, HER2-positive Breast Cancer
Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC
This study is a randomized, open-label, phase II study, comparing the efficacy and safety of trastuzumab plus aromatase inhibitors, with or without pyrotinib, in the treatment of HR (hormone receptor)+/HER2 (human epidermal…
- Conditions
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer
- Trial name
- Pyrotinib (NCT03910712)
- Testing
- Pyrotinib, Trastuzumab, Aromatase inhibitor
- Volunteers
- 250 people
- Sponsor
- Peking Union Medical College Hospital
Early and Locally Advanced Breast Cancer
ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early…
- Trial name
- TEODOR (NCT07084558)
- Testing
- blood sample for Signatera (TM) test, biopsy for Ki-67 assessment, FFPE tumor sample for Signatera (TM) test (archived)
- Where
- 14 sites in Austria
- Volunteers
- 350 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
Hormone Receptor-positive Advanced Breast Cancer
Chidamide Combined With Fulvestrant for HR+/HER2-advanced Breast Cancer
evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+ABC
- Trial name
- NCT05808582
- Testing
- chidamide，fulvestrant
- Volunteers
- 60 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Metastatic Breast Cancer
Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced Breast Cancer
The main purpose of this study was to evaluate the efficacy and safety of treatment with famitinib plus SHR6390 and endocrine therapy for hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative…
- Trial name
- NCT05176080
- Testing
- Famitinib, SHR6390, Fulvestrant
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals