Breast Cancer Stage IV Clinical Trial
Official title:
A Phase 1/2 Study of Tucatinib With Chemotherapy and Trastuzumab in Patients With Previously Treated, Advanced Her-2-Neu Overexpressing Breast Cancer.
This is an open label study of tucatinib in combination with either vinorelbine or gemcitabine and trastuzumab in patients with metastatic HER2+ breast cancer.
This phase I/II study will assess the recommended dosing of tucatinib in combination with trastuzumab and either vinorelbine or gemcitabine in patients with advanced, HER2+ breast cancer. The study will be conducted as a parallel cohort study looking at optimal dose and safety and efficacy. Arm 1 Gemcitabine + Tucatinib + Trastuzumab: Gemcitabine (1000 mg/m2) will be administered intravenously on Days 1 and 8. The investigational study drug (tucatinib) will be administered as 300mg by mouth taken twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each cycle. Arm 2 Vinorelbine + Tucatinib + Trastuzumab: Vinorelbine (25 mg/m2) will be administered intravenously on Days 1 and 8 of each cycle. The investigational study drug (tucatinib) will be administered as 300mg by mouth twice a day of every day in each cycle. Trastuzumab will be administered per package insert on Day 1 of each 2 cycle. Note: Cycle length is 21 days. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04469127 -
A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
| Withdrawn |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05377047 -
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
|
N/A | |
| Completed |
NCT03304210 -
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT05054374 -
A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05559528 -
BRaziLian outcomE for metAStatic breasT Cancer
|
||
| Active, not recruiting |
NCT05090358 -
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05033925 -
Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03401359 -
The Resistance and Immune Response to Palbociclib in Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT03870919 -
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
|
N/A | |
| Not yet recruiting |
NCT05860907 -
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
|
Phase 4 | |
| Completed |
NCT00393341 -
Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer
|
N/A | |
| Recruiting |
NCT05625087 -
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
|
Phase 2 | |
| Completed |
NCT04566458 -
RWD Study in HER2+ mBC Patients in Third-Line Therapy
|
||
| Recruiting |
NCT06075810 -
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04697043 -
The Benefit of Surgery in Stage IV of Breast Cancer
|
N/A | |
| Recruiting |
NCT05837533 -
Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients
|
N/A | |
| Active, not recruiting |
NCT03324425 -
Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05670054 -
Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients
|
Phase 3 |