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

NCT04293276 | Unknown Phase 2

• 1 other identifier: HR BLTN 014
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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)

• ORR

  ORR by investigator using RECIST Guideline (Version 1.1)

  From the start of treatment to Disease Progress, assessed up to 2 years

Secondary Outcomes (3)

• Adverse Events

  from the first drug administration to 30 days from the last dose, assessed up to 2 years

• PFS

  up to 2 years

• OS

  up to 2 years

Study Arms (1)

Treatment group

EXPERIMENTAL

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; Drug: SHR6390

Interventions

Pyrotinib DRUG

Pyrotinib Tablets

Treatment group

SHR6390 DRUG

SHR6390 Tablets

Treatment group

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 ≥ 2.0×10\^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.

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

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

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Related Publications (1)

• Yan M, Niu L, Lv H, Zhang M, Wang J, Liu Z, Chen X, Lu Z, Zhang C, Zeng H, Zhao S, Feng Y, Sun H, Li H. Dalpiciclib and pyrotinib in women with HER2-positive advanced breast cancer: a single-arm phase II trial. Nat Commun. 2023 Oct 7;14(1):6272. doi: 10.1038/s41467-023-41955-7.

  PMID: 37805496 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Min Yan, Professor

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: April 1, 2020
• Primary Completion: August 23, 2021
• Study Completion: May 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

CN (1)