Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-28

Study Completion Date

2023-05-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer

NCT03588091

HER2-positive Breast Cancer

COMPLETED PHASE3

A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer

NCT03863223

Metastatic Breast Cancer

UNKNOWN PHASE3

Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer

NCT04290793

Breast Cancer

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

NCT06035679

Breast Cancer Female

RECRUITING NA

Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

NCT04066790

Breast Cancer

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pyrotinib and docetaxel plus trastuzumab

Group Type EXPERIMENTAL

Docetaxel, trastuzumab

Intervention Type DRUG

Docetaxel and trastuzumab once per cycle

Pyrotinib

Intervention Type DRUG

Pyrotinib 400/320 mg orally daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel, trastuzumab

Docetaxel and trastuzumab once per cycle

Intervention Type DRUG

Pyrotinib

Pyrotinib 400/320 mg orally daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. HER2 positive recurrent or metastasis breast cancer.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Adequate organ function.
4. Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria

1. Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
2. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting.
3. Assessed by the investigator to be unable receive systemic chemotherapy.
4. History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
5. Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No