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

NCT ID: NCT04293276

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pyrotinib

Intervention Type: DRUG

Pyrotinib Tablets

SHR6390

Intervention Type: DRUG

SHR6390 Tablets

Interventions

Pyrotinib

Pyrotinib Tablets

Intervention Type: DRUG

SHR6390

SHR6390 Tablets

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Yan, Professor

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37805496 (View on PubMed)

Other Identifiers

HR BLTN 014

Identifier Type: -

Identifier Source: org_study_id