Pyrotinib in Combination With Letrozole in Patients With HER2-Positive, ER-Positive Metastatic Breast Cancer

NCT04407988 | Unknown Phase 2

• 1 other identifier: HR-BLTN-008
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, multi-center clinical study of pyrotinib in combination With letrozole in patients With HER2-Positive, ER-Positive metastatic breast cancer. Our aim was to explore the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive, ER-positive metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit rate (CBR)

  Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects

  Estimated 12 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Estimated 12 months

• Progression Free Survival (PFS)

  Estimated 12 months

• Overall Survival (OS)

  Estimated 24 months

• Adverse Events and Serious Adverse Events

  From informed consent through 28 days following treatment completion

Study Arms (1)

Pyrotinib plus Letrozole

EXPERIMENTAL

Drug: Pyrotinib Maleate plus Letrozole

Interventions

Pyrotinib Maleate plus Letrozole DRUG

pyrotinib(400 mg once daily) + Letrozole (2.5 mg once daily)

Pyrotinib plus Letrozole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HER2+/ER+ recurrent or metastatic breast cancer confirmed by histopathology;
• HER2 positive: HER2 IHC 3+, or HER2 IHC 2+ and ISH positive
• ER positive: the percentage of cells positive for ER expression ≥ 10%
• Premenopausal, perimenopausal or postmenopausal patients (with OFS, if pre- or perimenopausal);
• If the patient is bilateral breast cancer, metastasis lesions must be HER2 and ER positive;
• years old;
• ECOG PS 0～1;
• Life expectancy is not less than 12 weeks;
• At least one measurable lesion according to RECIST 1.1;
• Prior (neo) adjuvant trastuzumab, pertuzumab or chemotherapy were eligible, and the disease free interval must be greater than 12 months from completion of (neo) adjuvant trastuzumab and pertuzumab to metastatic diagnosis;
• Prior (neo) adjuvant hormone therapy was allowed, if received adjuvant AI, the disease free interval must be greater than 12 months from the completion of treatment;
• Disease-free Survival after surgery (DFS) ≥12 months;
• Patients with adequate organ function before enrollment: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, Hb ≥ 100 g/L; TBIL≤1.0ULN；ALT and AST≤3×ULN (ALT and AST≤5×ULN if liver metastasis); BUN and Cr≤1.5×ULN and CCr≥50 mL/min; LVEF ≥ 50% and QTc \< 480 ms;
• Signed informed consent.

You may not qualify if:

• Central nervous system metastasis;
• patients with Visceral crisis;
• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
• received radiotherapy, hormone therapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy for advanced or metastatic disease;
• received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks prior to randomization;
• Received hormone therapy within 2 weeks prior to randomization;
• Participated in other clinical trial within 4 weeks prior to randomization;
• Previous or ongoing use of HER2-targeted tyrosine kinase inhibitors (lapatinib, neratinib or pyrotinib);
• Other malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
• Receive other anti-tumour therapy at the same time;
• History of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known;
• History of any kind of Heart disease;
• All female patients in pregnancy or breastfeeding period, fertile women with positive baseline pregnancy tests;
• Evidence of significant medical illness that will substantially increase the risk on the participation or completion of the study in the investigator's judgment. Examples included, but not limited to, hypertension, severe diabetes, etc;
• History of neurological or psychiatric disorders, including epilepsy or dementia;

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

RECRUITING

Related Publications (1)

• Hu ZY, Yan M, Xiong H, Ran L, Zhong J, Luo T, Sun T, Xie N, Liu L, Yang X, Xiao H, Li J, Liu B, Ouyang Q. Pyrotinib in combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer (PLEHERM): a multicenter, single-arm, phase II trial. BMC Med. 2023 Jun 26;21(1):226. doi: 10.1186/s12916-023-02943-2.

  PMID: 37365596 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Quchang Ouyang, PhD

  Department of Breast Cancer Medical Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quchang Ouyang, PhD

CONTACT

+86 13973135318; Oyqc1969@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pyrotinib plus Letrozole

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: November 6, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2023
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

CN (1)