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Taxane combined with lobaplatin or anthracycline for neoadjuvant chemotherapy of triple-negative breast cancer: a randomized, controlled, phase-II clinical study

Taxane combined with lobaplatin or anthracycline for neoadjuvant chemotherapy of triple-negative breast cancer: a randomized, controlled, phase-II clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023776
Enrollment
Unknown
Registered
2019-06-11
Start date
2019-06-13
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Triple negative breast cancer

Interventions

Group 1:taxane + lobaplatin
Group 2:taxane + anthracycline

Sponsors

Southwest Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18 to 75 years old, female; 2) Primary breast cancer confirmed by histopathology with T1c stage and above; 3) ER negative, PR negative, HER-2 negative confirmed by immunohistochemistry (IHC); 4) At least one measurable objective lesion with a tumor diameter > 1 cm according to the RECIST 1.1 ; 5) ECOG physical fitness score of 0-1; 6) LVEF=55%; 7) Bone marrow function: neutrophils =1.5×10^9/L, platelets=100×10^9/L, hemoglobin=90g/L; 8) Liver and kidney function: serum creatinine = 1.5 times the upper limit of normal; AST and ALT = 2.5 times the upper limit of normal; total bilirubin = 1.5 times the upper limit of normal, or patients with Gilbert's syndrome = 2.5 times the upper limit of normal; 9) The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form; 10) Volunteer to participate in the study, and both treatment methods are accepted, and are willing to accept one of them randomly.

Exclusion criteria

Exclusion criteria: 1) Receive cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason; 2) New York Heart Association (NYHA) scores for heart disease patients above grade II (including grade II); 3) Patients with severe systemic infections or other serious illnesses; 4) Patients known to be allergic or intolerant to chemotherapeutic drugs or their excipients; 5) Other malignant tumors have occurred in the past 5 years, except for cured cervical cancer in situ and non-melanoma skin cancer; 6) Pregnancy or lactation, and women of childbearing age who refuse to take appropriate contraceptive measures during the trial; 7) The first dose of research drug participated in other experimental studies within 30 days before drug administration; 8) The investigator judged patients who were not eligible to participate in the study.

Design outcomes

Primary

MeasureTime frame
pathological complete remission;

Secondary

MeasureTime frame
event-free survival;overall survival;

Countries

China

Contacts

Public ContactXiaowei Qi

Southwest Hospital, Army Medical University

qxw9908@foxmail.com+86 135 2754 5423

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026