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

Phase 2

• Conditions: Breast Cancer; Brain Metastases
• Interventions: Drug: Pyrotinib Plus Vinorelbine

• Registration Number: NCT03933982
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-22
• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Status Verified: 2019-05
• Study First Posted: 2019-05-01
• Last Update Submitted: 2019-05-27
• Last Update Posted: 2019-05-29
• Primary Completion: 2021-12-22
• Study Completion: 2022-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pyrotinib plus Vinorelbine	Pyrotinib Plus Vinorelbine	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) of CNS	Estimated up to 1 year	ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.

Secondary Outcome Measures

Name	Time	Method
Time to radiotherapy	Estimated up to 1 year	Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.
Time to progression (TTP)	Estimated up to 1 year	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.
OS (overall survival)	Estimated up to 1 year	OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China