Phase II Clinical Study of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer

NCT03923179 | Unknown Phase 2

• 1 other identifier: LQ007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of Pyrotinib Combined With Etoposide to Treat HER2-positive Advanced Breast Cancer

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  Refers to the proportion of patients whose tumors have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission

  4 months

Secondary Outcomes (2)

• Progression Free Survival(PFS)

  4 months

• disease control rate(DCR)

  4 months

Study Arms (1)

pyrotinib+Etoposide

EXPERIMENTAL

Drug: Pyrotinib; Drug: Etoposide

Interventions

Pyrotinib DRUG

Pyrotinib, 400mg qd

pyrotinib+Etoposide

Etoposide DRUG

Etoposide, 50mg，qd,d1-21,Q4W

pyrotinib+Etoposide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age：18\~75 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• A life expectancy of more than 12 weeks;
• patients have at least one measurable lesion exists according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and progresses after the last anti-tumor treatment or during treatment;
• Pathologically confirmed HER2-expressing patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification
• Progression after treatment with trastuzumab or treatment, patients who are no longer able to receive trastuzumab or lapatinib: continuous use of trastuzumab ≥ 2 cycles during relapse/metastasis Or during the adjuvant treatment, continuous use of trastuzumab ≥ 3 months, recurrence / metastasis after treatment or treatment;
• echocardiography indicates that LVEF ≥ 50%;
• The laboratory tests confirmed that the bone marrow function and liver and kidney function of the patient met the following requirements before the first dose:
• ANC≥1.5×10\^9/L；
• PLT≥100×10\^9/L;
• Hb≥100 g/L
• serum creatinine(Scr) less than 1.5 times the upper limit of normal value or the creatinine clearance rate calculated greater than 60 mL/min;
• total bilirubin less than 1.5 times the upper limit of normal value
• aspartate aminotransferase (AST), or alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases;
• urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;

You may not qualify if:

• Previously treated with pyrrolidine or neratinib;
• Previously received etoposide treatment;
• Patients with high blood pressure who are not well controlled by antihypertensive medication (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg); have uncontrolled or severe cardiovascular disease, such as within 6 months before screening Refractory angina pectoris, congestive heart failure occurred; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, QT interval prolongation; history of cerebrovascular accident, symptomatic and need Medically treated coronary heart disease;
• having significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
• Refractory, 2 degrees and above persistent diarrhea;
• exiting unstable brain metastasis and / or meningeal metastasis;
• Have undergone major surgery or severe traumatic injury, fracture, or healed wound within 4 weeks;
• Allergic to pyrotinib, etoposide and/or its excipients has been confirmed;
• Female patients during pregnancy or lactation, female patients with fertility and positive pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;
• The patient has a severe concomitant disease, or any other condition that the investigator believes is not suitable for the study.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• Liu J, He M, Jiang M, Zhou S, Zhang M, Li Y, Chen S, Cai R, Mo H, Lan B, Ma F, Xu B, Li Q. Pyrotinib combined with metronomic etoposide in heavily pretreated HER2-positive metastatic breast cancer: a single-arm, phase II study. BMC Cancer. 2024 Oct 18;24(1):1290. doi: 10.1186/s12885-024-13041-8.

  PMID: 39425028 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Qiao I Li

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Binghe Xu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe I Xu

CONTACT

8687788826; xubinghe@medmall.com

Qiao I Li

CONTACT

8687788120; Liqiaopumc@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 22, 2019
• Study Start: April 19, 2019
• Primary Completion: April 1, 2021
• Study Completion: December 31, 2021
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

CN (1)