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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; HER2-positive Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib Plus Fulvestrant

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Peng Yuan; Phone Number: +8613501270834; Email: yuanpeng01@hotmail.com
• Study Contact Backup: Name: Jian Yue; Phone Number: +8618612621749; Email: sunlight_1985@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Contact: Peng Yuan; Phone Number: +8613501270834; Email: yuanpeng01@hotmail.com
      • Contact: Jian Yue; Phone Number: +8618612621749; Email: sunlight_1985@163.com
      • Principal Investigator: Peng Yuan
      • Sub-Investigator: Jian Yue

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. 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.

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 Fulvestrant	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective Response Rate (ORR)	Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.	Estimated up to 1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Principal Investigator: Jian Yue, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Metastatic Breast Cancer, Pyrotinib, Fulvestrant
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant
• Other Study ID Numbers: NCC2018M-042

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