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Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer

Primary Purpose

Breast Cancer, Pyrotinib, Breast Diseases

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pyrotinib 320mg + Vinorelbine

Pyrotinib 400mg + Vinorelbine

Pyrotinib plus Vinorelbine

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed invasive breast cancer
HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent. Patients who have previously used pertuzumab will be allowed.
Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator
Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded
Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

History of treatment with pyrotinib
Prior treatment with lapatinib or neratinib
History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma
History of receiving any anti-cancer drug/biologic or investigational treatment within 28 days prior to randomization except hormone therapy
Recovery of treatment-related toxicity consistent with other eligibility criteria
History of radiation therapy within 28 days of randomization
Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization
History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
History of myocardial infarction or unstable angina
Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
Pregnancy or lactation
Current known active infection with human immunodeficiency virus (HIV) or hepatitis C virus
Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis

Sites / Locations

Zhang JingminRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrotinib plus vinorelbine

Arm Description

Outcomes

Primary Outcome Measures

PFS as Assessed by the Investigator

Progression-Free Survival

Secondary Outcome Measures

Objective Response Rate

from enrollment to progression or death (for any reason), assessed up to 3 years

OS was defined as the time from the date of randomization to the date of death from any cause.

Full Information

NCT ID

NCT04605575

First Posted

October 22, 2020

Last Updated

April 24, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04605575

Brief Title

Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer

Official Title

A Single-arm, Multi-center Phase II Clinical Study of Pyrotinib Combined With Vinorelbine in the Treatment of HER2-positive and Treated Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 22, 2020 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors. In the second part of the study, we will explore the safety and efficacy of Pyrotinib + vinorelbine in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Pyrotinib, Breast Diseases, Vinorelbine, HER2-positive Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pyrotinib plus vinorelbine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pyrotinib 320mg + Vinorelbine

Intervention Description

pyrotinib 320mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles

Intervention Type

Drug

Intervention Name(s)

Pyrotinib 400mg + Vinorelbine

Intervention Description

pyrotinib 400mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles

Intervention Type

Drug

Intervention Name(s)

Pyrotinib plus Vinorelbine

Intervention Description

pyrotinib administered daily by mouth（MTD）, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle, or vinorelbine(iv) 25 mg/m2 on day 1 and day 8 of 21 day cycle. Treatments will lasts until disease progression (as assessed by the investigator) or unmanageable toxicity.

Primary Outcome Measure Information:

Title

PFS as Assessed by the Investigator

Description

Progression-Free Survival

Time Frame

from enrollment to progression or death (for any reason), assessed up to 3 years

Secondary Outcome Measure Information:

Title

Objective Response Rate

Description

from enrollment to progression or death (for any reason), assessed up to 3 years

Time Frame

Ratio of CR and PR in all subjects

Title

Description

OS was defined as the time from the date of randomization to the date of death from any cause.

Time Frame

from enrollment to progression or death (for any reason), assessed up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed invasive breast cancer HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent. Patients who have previously used pertuzumab will be allowed. Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: History of treatment with pyrotinib Prior treatment with lapatinib or neratinib History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma History of receiving any anti-cancer drug/biologic or investigational treatment within 28 days prior to randomization except hormone therapy Recovery of treatment-related toxicity consistent with other eligibility criteria History of radiation therapy within 28 days of randomization Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment History of myocardial infarction or unstable angina Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease) Pregnancy or lactation Current known active infection with human immunodeficiency virus (HIV) or hepatitis C virus Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wang shusen

Phone

+86-13926168469

wangshs@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

zhang jingmin

Phone

+8618826246924

zhangjm1@sysucc.org.cn

Facility Information:

Facility Name

Zhang Jingmin

City

Guangzhou

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

zhang jingmin

Phone

+8618826246924

zhangjm1@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31430226

Citation

Ma F, Ouyang Q, Li W, Jiang Z, Tong Z, Liu Y, Li H, Yu S, Feng J, Wang S, Hu X, Zou J, Zhu X, Xu B. Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study. J Clin Oncol. 2019 Oct 10;37(29):2610-2619. doi: 10.1200/JCO.19.00108. Epub 2019 Aug 20.

Results Reference

background

PubMed Identifier

28115222

Citation

Li X, Yang C, Wan H, Zhang G, Feng J, Zhang L, Chen X, Zhong D, Lou L, Tao W, Zhang L. Discovery and development of pyrotinib: A novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor with favorable safety profiles for the treatment of breast cancer. Eur J Pharm Sci. 2017 Dec 15;110:51-61. doi: 10.1016/j.ejps.2017.01.021. Epub 2017 Jan 21.

Results Reference

background

PubMed Identifier

28498781

Citation

Ma F, Li Q, Chen S, Zhu W, Fan Y, Wang J, Luo Y, Xing P, Lan B, Li M, Yi Z, Cai R, Yuan P, Zhang P, Li Q, Xu B. Phase I Study and Biomarker Analysis of Pyrotinib, a Novel Irreversible Pan-ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2017 Sep 20;35(27):3105-3112. doi: 10.1200/JCO.2016.69.6179. Epub 2017 May 12.

Results Reference

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Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer

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