Clinical trials: HR+ Breast Cancer
Breast Cancer, HER2-low-expressing Breast Cancer
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR…
- Conditions
- Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy
- Trial name
- NCT05165225
- Testing
- Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer Metastatic
Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves…
- Trial name
- NCT07137871
- Testing
- Avasopasem
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 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 GVV858 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
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Female
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study.
- Trial name
- ADAPTlate (NCT04565054)
- Testing
- Abemaciclib 50 MG; 150mg 1-0-1 per os
- Where
- 85 sites in Germany, Poland and 1 more
- Volunteers
- 1,260 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer
A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Trial name
- NCT07358377
- Testing
- HRS-6209 Capsules and fulvestrant injection
- Where
- 6 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Atridia Pty Ltd.
Breast Cancer, Advanced Breast Cancer
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF1 subtype of advanced breast cancer.
- Trial name
- BCTOP-L-M01 (NCT05949541)
- Testing
- Everolimus 10 mg, CDK4/6 Inhibitor SHR6390, Aromatase inhibitor and Fulvestrant combined with CDK4/6 inhibitors
- Where
- China
- Volunteers
- 265 people
- Sponsor
- Fudan University
CANCER, BRAEST CANCER
Dalpiciclib Plus Toremifene for First-line Advanced HR Positive and HER2 Negative Breast Cancer
Experimental population:Advanced first-line HR+, HER2 metastatic breast cancer patients Research endpoint: Main research endpoint: PFS evaluated by researchers (according to RECIST 1.1 standard) Secondary study endpoint…
- Conditions
- CANCER, BRAEST CANCER, Late Frontline
- Trial name
- NCT06495515
- Testing
- Dalpiciclib，Toremifen
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
HR+/HER2- Breast Cancer
Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer
This study is looking to see whether the combination of Tucidinostat and nab-paclitaxel is safe and effective in participants with advanced HR+/HER2- breast cancer.
- Trial name
- NCT05633914
- Testing
- Tucidinostat, nab-paclitaxel
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Hunan Cancer Hospital
HR+HER2- Advanced Breast Cancer
A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation
This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in…
- Trial name
- PARFENOPA (NCT06625333)
- Where
- 20 sites in Russia
- Volunteers
- 329 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Breast Cancer Stage IV
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
The purpose of this study to find out whether a very low carbohydrate diet (ketogenic diet), a low carbohydrate diet, or the study drug canagliflozin can prevent high blood sugar and may improve the effectiveness of cancer…
- Conditions
- Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer
- Trial name
- NCT05090358
- Testing
- Ketogenic Diet, Low Carbohydrate Diet, Alpelisib
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC)…
- Trial name
- LEEWARD (NCT07647042)
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal hormone receptor-positive (HR+)…
- Trial name
- TATEN (NCT04251169)
- Testing
- Pembrolizumab, Paclitaxel
- Where
- 7 sites in Spain
- Volunteers
- 20 people
- Sponsor
- SOLTI Breast Cancer Research Group
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
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
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Breast Cancer
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells…
- Trial name
- NoLEEta (NCT07237256)
- Testing
- Chemotherapy followed by endocrine therapy and ribociclib treatment, De-escalation
- Where
- 138 sites in France, Germany and 3 more
- Volunteers
- 3,902 people
- Sponsor
- UNICANCER
Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer: Arm A: concomitant cyclin-dependent Kinase 4/6…
- Conditions
- Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- KENDO (NCT03227328)
- Testing
- concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy, chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)
- Where
- 20 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Epithelial Tumors, Malignant
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
- Trial name
- MYE Symphony (NCT05969041)
- Testing
- MT-302 (A)
- Where
- 6 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Myeloid Therapeutics
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines