Breast Cancer
Conditions
Brief summary
This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
Interventions
DRUGHRS-6209 Capsules
Oral HRS-6209 capsules.
Oral Letrozole tablets.
DRUGHRS-2189 Tablets
HRS-2189 tablets.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18-75 years. 2. ECOG performance status 0-1. 3. Menopausal status. 4. Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration. 5. At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria. 6. Expected survival \> 3 months. 7. Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding. 8. Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form.
Exclusion criteria
1. Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use. 2. History of clinically serious cardiovascular disease. 3. The ECG examination was abnormal. 4. Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding. 5. The subjects were in acute infection or active tuberculosis and needed drug treatment. 6. The patients received surgery, chemotherapy, immunotherapy and macromolecular targeted therapy within 4 weeks before the first medication. 7. Pregnant and lactating women, or intending to become pregnant during the study. 8. There was a clear history of neurological or mental disorders and the subjects had a history of psychotropic drug abuse or drug abuse. 9. In the course of this study, it is expected to receive other anti-tumor treatments or drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | About 1 year. |
| Maximum tolerated dose (MTD) | 28 days after the first dose. |
| Recommended phase II dose (RP2D) | 28 days after the first dose. |
| Adverse events (AEs) | About 1 year. |
| Serious adverse events (SAEs) | About 1 year. |
| Dose-limiting toxicity (DLT) | 28 days after the first dose. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR) | About 1 year. |
| Clinical benefit rate (CBR) | About 1 year. |
| Progression-free survival (PFS) | About 1 year. |
| Best overall response (BOR) | About 1 year. |
Countries
China
Contacts
Primary ContactXiaoyu Zhu
Outcome results
None listed