Clinical trial NCT03959397: Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer
Official title: A Real-world Study of Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Stage
Keywords: Breast cancer; neoadjuvant therapy; Nab-paclitaxel
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neoadjuvant chemotherapy is a systemic cytotoxic drug therapy for non-metastatic tumors before local therapy, Now it has become an important part of standard treatment for a stage II, III, and the first clinical Ⅳ breast cancer .Both domestic and foreign authoritative guidelines recommend the use of albumin-binding paclitaxel in the neoadjuvant treatment of breast cancer .In addition, clinical studies at home and abroad have preliminarily confirmed the application value and therapeutic benefit of albumin-binding paclitaxel in breast cancer neoadjuvant therapy, and the toxic and side effects can be tolerated.

Detailed description: Data were collected on the efficacy and safety of neoadjuvant therapy in patients receiving albumin-binding taxol regimens,Subgroup analysis was performed for different treatment regimens, dosages, molecular subtypes and tumor stages,To further screen the dominant population and the chemotherapy regimen with clinical benefit of albumin paclitaxel, so as to provide evidence-based medical evidence for breast cancer neoadjuvant clinical diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

1. Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study.
2. target population 1)The histologic diagnosis of the primary invasive breast cancer and clinical stage I - III, first option Ⅳ period; 2) One of the following conditions:Large mass (\>3cm);Axillary lymph node metastasis;her-2 positive; tri-negative; For those who are willing to preserve breast, but have difficulty in breast conserving due to the large proportion of tumor size and breast volume; 3) The clinician determined that the patient was suitable for the treatment with albumin-binding taxol regimen;4) The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study 5)No contraindications for nab-paclitaxel.
3. Age and reproductive status 1) Age ≥ 18 years 2) Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy; 3) Women must not lactate.

Exclusion Criteria:

1. Allergy to paclitaxel for injection (albumin binding) and/or its adjuvants has been demonstrated;
2. Pregnant or lactating women
3. Abnormal results of physical examination and laboratory examination 1) Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 × 109/L; Hemoglobin (Hgb) \< 90g/L 2) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) \>2.5 × institutional upper limit of normal (ULN), \>5 × institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)\>1.5 × ULN; 3) Creatinine (CRE)\> 1.5 × ULN 4) Prothrombin time (PT) and international normalized ratio (INR) \> 1.5 × ULN. Unless the subject had received anticoagulant treatment
4. Paclitaxel for injection (albumin binding type) contraindications in patients
5. Participating in clinical trials of other taxoids
6. Patients with concomitant other tumors, other than cured carcinoma in situ of the cervix and non-melanoma skin cancer
7. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
8. The researchers considered that there were other conditions that were not suitable for enrollment.

Primary outcomes:
measure: the Pathological complete remission(pCR)
timeFrame: 2 weeks
measure: Disease-free survival (DFS)
timeFrame: 6 months
Secondary outcomes:
measure: the overall survival (OS)
timeFrame: 6 months
measure: Breast conserving rate
timeFrame: 6 months
Other outcomes:
measure: Adverse events (AE)
timeFrame: 6 months
Locations:
city: Jilin
country: China
facility: the first hospital of Jilin University
state: Changchun
Study officials:
affiliation: The First Hospital of Jilin University
name: Fan zhimin, Doctor
role: STUDY_DIRECTOR
References:
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citation: Zong Y, Wu J, Shen K. Nanoparticle albumin-bound paclitaxel as neoadjuvant chemotherapy of breast cancer: a systematic review and meta-analysis. Oncotarget. 2017 Mar 7;8(10):17360-17372. doi: 10.18632/oncotarget.14477.
citation: Nahleh ZA, Barlow WE, Hayes DF, Schott AF, Gralow JR, Sikov WM, Perez EA, Chennuru S, Mirshahidi HR, Corso SW, Lew DL, Pusztai L, Livingston RB, Hortobagyi GN. SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer. Breast Cancer Res Treat. 2016 Aug;158(3):485-95. doi: 10.1007/s10549-016-3889-6. Epub 2016 Jul 8.