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

Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Brain Metastases
• Intervention / Treatment: Drug: Pyrotinib Plus Vinorelbine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Contact: Phone Number: +8615652632903; Email: yuanpeng01@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age18-75 years.
2. ECOG performance status ≤2.
3. Histologically confirmed HER2 positive advanced breast cancer.
4. Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
5. Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
6. Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.).
7. 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;
8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pyrotinib plus Vinorelbine	Drug: Pyrotinib Plus Vinorelbine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression (TTP)	TTP, defined as the time from the date of informed consent until the date of disease progression (PD), either CNS PD or extracranial PD, whichever comes first.	Estimated up to 1 year
OS (overall survival)	OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.	Estimated up to 1 year
Time to radiotherapy	Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.	Estimated up to 1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: Peng Yuan, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2018
• Primary Completion (Anticipated): December 22, 2021
• Study Completion (Anticipated): June 22, 2022

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: NCC1865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No