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Efficacy and safety of Piperoxili capsule combined with endocrine therapy for breast cancer

Efficacy and safety of Piperoxilium capsule combined with endocrine therapy for hormone receptor (HR) positive breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082311
Enrollment
Unknown
Registered
2024-03-26
Start date
2024-04-14
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HR positive breast cancer

Interventions

Test group:After the progression of endocrine therapy: Piperoxili capsule combined with fluvestrant injection. Without endocrine therapy: Exemestane monotherapy or piperacillin capsules combined with

Sponsors

Taizhou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Age above 18 years old (including 18 years old), regardless of gender.; 2.HR positive breast cancer consistent with pathological diagnosis.; 3.Informed consent, volunteer. The process of obtaining informed consent shall comply with GCP regulations.;

Exclusion criteria

Exclusion criteria: 1.For pregnant and lactating women, the subjects refused to take effective contraceptive methods.; 2.Patients with a history of uncontrolled epilepsy, central nervous system disease, or mental disorders were assessed by the investigator as to whether their clinical severity prevented the signing of informed consent or affected the patient's adherence to oral medications.; 3.Patients who are allergic to any therapeutic drug or its excipient ingredients.; 4.Known human immunodeficiency virus (HIV) infection (known HIV antibody positive).; 5.Inability to swallow, intestinal obstruction, or other factors that affect the taking and absorption of the drug.; 6.In the judgment of the investigator, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's ability to complete the study (including but not limited to severe high blood pressure that cannot be controlled by the drug, severe diabetes, active infection, etc.).; 7.The patient did not recover from the toxic effects of previous treatment to grade 0-1 (except for hair loss).; 8.The investigator did not consider the patient suitable for participation in any other condition of the study.;

Design outcomes

Primary

MeasureTime frame
Event-free survival (EFS);

Secondary

MeasureTime frame
Progression-free survival, objective response rate, disease control rate, duration of efficacy;Blood, urine routine, stool routine. Electrocardiogram, Liver function , renal function.;

Countries

China

Contacts

Public ContactChen Qiulan

Taizhou Hospital of Traditional Chinese Medicine

723580025@qq.com+86 13951163215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026