A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

NCT03933982 | Unknown Phase 2

• 1 other identifier: NCC1865
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.

Conditions

Breast Cancer; Brain Metastases

Keywords

Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) of CNS

  ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.

  Estimated up to 1 year

Secondary Outcomes (3)

• Time to progression (TTP)

  Estimated up to 1 year

• OS (overall survival)

  Estimated up to 1 year

• Time to radiotherapy

  Estimated up to 1 year

Study Arms (1)

Pyrotinib plus Vinorelbine

EXPERIMENTAL

Drug: Pyrotinib Plus Vinorelbine

Interventions

Pyrotinib Plus Vinorelbine DRUG

Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.

Pyrotinib plus Vinorelbine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age18-75 years.
• ECOG performance status ≤2.
• Histologically confirmed HER2 positive advanced breast cancer.
• Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
• Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
• Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.).
• Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm;
• Signed the informed consent form prior to patient entry.

You may not qualify if:

• Participated in other drug clinical trials within 4 weeks before the start of the study;
• Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study;
• Received endocrine therapy within 7 days before the start of the study;
• Suitable for surgical resection;
• Accompanied by rapid progress of organ invasion;
• Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.).
• Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs;
• Allergies to any compounds of experimental drugs;
• CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia;
• Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma.
• Any other situations judged by investigator as not suitable for participating in this study.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

pyrotinib; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Peng Yuan, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Peng Yuan, M.D.

CONTACT

+8613501270834; yuanpeng01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: December 22, 2018
• Primary Completion: December 22, 2021
• Study Completion: June 22, 2022
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)