Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer (DAP-Her-01)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Pyrotinib; Drug: SHR6390

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Patients with HER2 positive breast cancer will receive Pyrotinib in combination with SHR6390(at protocol defined dose levels) orally until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.	Drug: Pyrotinib; Pyrotinib Tablets; Drug: SHR6390; SHR6390 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	ORR by investigator using RECIST Guideline (Version 1.1)	From the start of treatment to Disease Progress, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	up to 2 years
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
PFS	Progression-Free Survival	up to 2 years

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Min Yan, Professor, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): August 23, 2021
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 29, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HR BLTN 014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No