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

Breast Cancer Clinical Trial

— Pyrotinib  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03933982
• Other study ID #: NCC1865
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2018
• Est. completion date: June 22, 2022

Study information

• Verified date: May 2019
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, M.D.
• Phone: +8613501270834
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 22, 2022
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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