Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer

NCT03993964 | Unknown Phase 2

• 1 other identifier: HR-BLTN-014
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  CR+PR

  from enrollment to progression or death (for any reason), assessed up to 100 months

Secondary Outcomes (2)

• PFS

  from enrollment to progression or death (for any reason),assessed up to 100 months

• OS

  from enrollment to death (for any reason).assessed up to 100 months

Study Arms (1)

Experimental: Pyrotinib + SHR6390

EXPERIMENTAL

Pyrotinib combine with SHR6390 should be administrate to all subjects. pyrotinib 400mg qd combined with SHR 6390 125mg qd

Drug: Pyrotinib combine with SHR6390

Interventions

Pyrotinib combine with SHR6390 DRUG

SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway. Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic breast cancer

Experimental: Pyrotinib + SHR6390

Eligibility Criteria

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

You may qualify if:

• Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
• HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
• Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;
• years old.
• ECOG PS 0～1.
• life expectancy is not less than 12 weeks.
• at least one measurable lesion according to RECIST 1.1.
• ANC ≥ 2.0×109/L,PLT ≥ 100×109/L,Hb ≥ 90 g/L;TBIL≤1.5ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN
• LVEF ≥ 50% and QTc≤470 ms.

You may not qualify if:

• Patients with symptomatic brain metastasis;
• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
• patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
• Participated in other drug clinical trials within 4 weeks before admission
• Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
• Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
• A history of immunodeficiency, including HIV positive, HCV,, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
• Has suffered from any heart disease
• Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
• According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
• Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever（\> 38.5 ℃） of unknown origin occurs during the screening period/before the first administration.
• Researchers believe that patients are not suitable for any other situation in this study.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

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: June 13, 2019
• First Posted: June 21, 2019
• Study Start: August 15, 2019
• Primary Completion: October 30, 2020
• Study Completion: April 15, 2021
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share