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A single-center and single-arm clinical study of neoadjuvant nab-paclitaxel combined with carboplatin therapy in patients with triple-negative or HER2-positive breast cancer

A single-center and single-arm clinical study of neoadjuvant nab-paclitaxel combined with carboplatin therpy in patients with triple-negative or HER2-positive breast cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027332
Enrollment
Unknown
Registered
2019-11-09
Start date
2019-11-18
Completion date
Unknown
Last updated
2019-11-11

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

Conditions

breast cancer

Interventions

experimental group:nab-paclitaxel combined with carboplatin

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) age: 18-70 years old, female; 2) patients with primary breast cancer, T2 or above, diagnosed by histopathology; 3) histological diagnosis of HER2 positive or triple negative breast cancer; ER / PR was detected by immunohistochemistry (ICH); HER2 positive was defined as ICH 3 + or in situ hybridization to confirm gene amplification. 4) according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter > 2cm. 5) ECoG physical fitness score 0-1; 6) LVEF >= 55% 7) bone marrow function: neutrophil >= 1.5 x 10^9 /L, platelet>= 100 x 10^9 /L, hemoglobin >= 90g /L; 8) liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and alt <= 2.5 times the upper limit of normal value; total bilirubin <= 1.5 times the upper limit of normal value, or patients with Gilbert's syndrome <= 2.5 times the upper limit of normal value; 9) patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; 2) patients with stage IV metastasis at the initial diagnosis; 3) New York Heart Association (NYHA) rating of patients with heart disease above grade II (including grade II); 4) patients with serious systemic infection or other serious diseases; 5) patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants; 6) in the past 5 years, there have been other malignant tumors, except the cured carcinoma in situ of cervix and skin cancer without melanoma; 7) pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial; 8) participated in other experimental studies within 30 days before the administration of the first study drug; 9) patients not suitable for the study were judged by the researchers.

Design outcomes

Primary

MeasureTime frame
pathologic complete response;

Secondary

MeasureTime frame
ORR;DFS;Breast conserving rate;Safety;

Countries

China

Contacts

Public ContactTing 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