Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
NCT04246502 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2020-02-05
Summary
This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
Conditions
Interventions
- DRUG
-
Capecitabine and Pyrotinib
Pyrotinib 400mg orally daily until progressive disease
- DRUG
-
Capecitabine,Trastuzumab, and Pertuzumab
as instruction
Sponsors & Collaborators
-
Shandong Cancer Hospital and Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-31
- Primary Completion
- 2022-12-31
- Completion
- 2024-12-31
More Related Trials
-
Pyrotinib Combined With Capecitabine Metronomic Therapy in HER2-postitive Advanced Breast Cancer
NCT03923166 ·Status: UNKNOWN ·Phase: PHASE2
-
Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
NCT05359120 ·Status: UNKNOWN
-
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
NCT07019337 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
NCT05346861 ·Status: UNKNOWN ·Phase: PHASE3
-
Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
NCT02361112 ·Status: COMPLETED ·Phase: PHASE1
-
Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2+ Study of Breast Cancer
NCT06483386 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases
NCT06152822 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis
NCT06015100 ·Status: UNKNOWN ·Phase: NA
-
A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
NCT03691051 ·Status: UNKNOWN ·Phase: PHASE2
-
Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis
NCT04639271 ·Status: UNKNOWN ·Phase: PHASE2
-
Pyrotinib Plus Vinorelbine Versus Lapatinib Plus Capecitabine
NCT04850625 ·Status: COMPLETED
-
Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)
NCT03080805 ·Status: UNKNOWN ·Phase: PHASE3
-
Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC
NCT03910712 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy
NCT05560308 ·Status: UNKNOWN ·Phase: NA
-
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
NCT04088110 ·Status: UNKNOWN ·Phase: PHASE2
-
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
NCT06525766 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases
NCT05042791 ·Status: RECRUITING ·Phase: PHASE2
-
Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
NCT03979911 ·Status: UNKNOWN
-
Pertuzumab in First Line Treatment of HER2-positive Metastatic Breast Cancer Patients
NCT02642458 ·Status: UNKNOWN
-
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)
NCT00629148 ·Status: COMPLETED ·Phase: PHASE2
-
SHR-A1811 and THPy in First or Second Line for HER2 Positive Advanced Breast Cancer Brain Metastases
NCT06975475 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
NCT05861271 ·Status: RECRUITING ·Phase: PHASE2
-
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
NCT03204734 ·Status: UNKNOWN ·Phase: PHASE2
-
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
NCT04159142 ·Status: RECRUITING ·Phase: PHASE2
-
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
NCT04681911 ·Status: UNKNOWN ·Phase: PHASE2