Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer

Metastatic Breast Cancer Clinical Trial

— DAP-Her-01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04293276
• Other study ID #: HR BLTN 014
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2020
• Est. completion date: May 2023

Study information

• Verified date: April 2023
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: May 2023
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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;

• 18-70 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 = 2.0×10^9/L, PLT = 100×10^9/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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Pyrotinib
Pyrotinib Tablets
• SHR6390
SHR6390 Tablets

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	ORR by investigator using RECIST Guideline (Version 1.1)	From the start of treatment to Disease Progress, assessed up to 2 years
Secondary	Adverse Events	The number of patients experiencing any adverse events (AE) during the study time	from the first drug administration to 30 days from the last dose, assessed up to 2 years
Secondary	PFS	Progression-Free Survival	up to 2 years
Secondary	OS	Overall Survival	up to 2 years