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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer HER2-positive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pyrotinib plus Fulvestrant

Group Type EXPERIMENTAL

Pyrotinib Plus Fulvestrant

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No