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A single-center, prospective, real-world study of chidamide in combination therapy for advanced breast cancer

A single-center, prospective, real-world study of chidamide in combination therapy for advanced breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034301
Enrollment
Unknown
Registered
2020-07-01
Start date
2020-08-01
Completion date
Unknown
Last updated
2021-06-14

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

Conditions

advanced breast cancer

Interventions

case series:Chidamide and combination drug

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female, aged >= 18 years (including 18 years); 2. Histologically or cytologically confirmed breast cancer.Postmenopausal and premenopausal patients with hormone receptor-positive patients can be treated with ovarian function inhibition (OFS) at the same time, but premenopausal patients should be treated with ovarian function inhibition (menopausal criteria: judgment criteria of adjuvant therapy for postmenopausal women with breast cancer in China and consensus on clinical application of aromatase inhibitors. Chinese journal of cancer,2012,22(3):238-240.) 3. Patients with inoperable recurrent or metastatic breast cancer and at least one measurable lesion or no measurable lesion and simple bone metastasis before enrollment; 4. There is no limit to the number of lines of previous chemotherapy and total treatment; 5. ECOG physical condition score 0-2; 6. Volunteer to participate in this clinical trial and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Received major surgical operations or significant trauma within 4 weeks prior to enrollment, or expected to receive major surgical treatment; 2. Those with a history of allergy to the drug components of the program; 3. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 4. Positive tests on baseline pregnancy tests for pregnant, lactating or fertile women; Subjects of childbearing age who were unwilling to use effective contraception during the study period and at least 8 weeks after the last administration; 5. Concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) that, as determined by the investigator, may seriously endanger the safety of the patient or affect the completion of the study; 6. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 7. The researcher judged that it was not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Secondary

MeasureTime frame
Objective remission rate;overall survival;Duration of remission;Clinical benefit rate;

Countries

China

Contacts

Public ContactHong Zheng, Ting Luo

West China Hospital, Sichuan University

tina621@163.com+86 18980606230

Outcome results

None listed

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