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Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer

NCT03308201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-03-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of Hemay022 combined with endocrine therapy in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR (best tolerated regimen). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with exemestane, and the safety of Hemay022 in combination with letrozole or fulvestrant.

The research will be divided into two parts. In the first part, 15 to 24 subjects will be enrolled to determine the safety and tolerability of combining Hemay022 with exemestane in patients with HER2-positive advanced breast cancer. The second part will enroll about 24-36 other subjects with ER and HER2-positive advanced breast cancer to better determine the tolerability and preliminary efficacy of Hemay022.

Conditions

Interventions

DRUG

Hemay022+exemestane

Part one: Hemay022 tablets will be taken orally once daily in doses of 200mg, 300mg,400mg or 500mg for 28 days in combination with exemestane. Part two: Hemay022 tablets combination with exemestane.

DRUG

Hemay022+letrozole

Part two: Hemay022 combination with letrozole.

DRUG

Hemay022+ fulvestrant

Part two: Hemay022 combination with fulvestrant.

Sponsors & Collaborators

  • Tianjin Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Huiping Li · Peking University Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2022-06-30
Completion
2023-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03308201 on ClinicalTrials.gov