Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )

Breast Cancer Clinical Trial

— Pyrotinib  

Official title:

Pyrotinib Plus Fulvestrant in Patients HR+/HER2+ Metastatic Breast Cancer : a Prospective, Single-arm, Single-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033172
• Other study ID #: NCC2018M-042
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2019
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan
• 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, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed).

2. ECOG score = 2, expected survival = 3 months.

3. Histology or cytology confirmed as breast cancer.

4. Prior to trastuzumab and endocrine therapy and progression/recurrence.

5. At least one RECIST 1.1 defined measurable lesions.

6. Normal function of major organs.

Exclusion Criteria:

1. pregnant or lactating women

2. Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib, trastuzumab), or other anti-tumor therapy. Except for endocrine therapy.

3. Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or =2 grade diarrhea caused by any cause at baseline).

4. Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.)

5. Patients with central nervous system disorders or mental disorders

6. Bone metastasis lesions only, no other measurable lesions.

7. Hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) without ideal control.

8. Uncontrolled heart disease.

9. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome.

10. Uncontrolled rain metastasis.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• Pyrotinib Plus Fulvestrant
Pyrotinib: 400 mg/d, q.d., p.o. A course of treatment need 28 days. Fulvestrant: 500 mg/m2 q.d. i.m. A course of treatment need 28 day. First course needs extra dose of fulvestrant 500 mg/m2 q.d. i.m. on day 15.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	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	Progression-Free Survival (PFS)	Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.	Estimated up to 1 year
Secondary	OS (overall survival)	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	Objective Response Rate (ORR)	Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.	Estimated up to 1 year