Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer

Breast Cancer Stage Clinical Trial

Official title:

A Real-world Study of Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03959397
• Other study ID #: CSPC-KAL-BC-12
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2019
• Source: Jilin University
• Contact: Fan zhimin, Doctor
• Phone: 13904321567
• Email: 13364308696[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? 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.

Related Conditions & MeSH terms

• Breast Cancer Stage
• Breast Neoplasms

Intervention

Drug:
• nab-paclitaxel
nab-paclitaxel monotherapy or combination therapeutic regimen

Locations

Country	Name	City	State
China	the first hospital of Jilin University	Jilin	Changchun

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

References & Publications (4)

Gluz O, Nitz U, Liedtke C, Christgen M, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Bangemann N, Lindner C, Kuemmel S, Clemens M, Potenberg J, Staib P, Kohls A, von Schumann R, Kates R, Kates R, Schumacher J, Wuerstlein R, Kreipe HH, Harbeck N. Comparison of Neoadjuvant Nab-Paclitaxel+Carboplatin vs Nab-Paclitaxel+Gemcitabine in Triple-Negative Breast Cancer: Randomized WSG-ADAPT-TN Trial Results. J Natl Cancer Inst. 2018 Jun 1;110(6):628-637. doi: 10.1093/jnci/djx258. — View 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. — View Citation

Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kümmel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynäkologische Onkologie—Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-56. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8. Erratum in: Lancet Oncol. 2016 Jul;17 (7):e270. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events (AE)	Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.	6 months
Primary	the Pathological complete remission(pCR)	Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.	2 weeks
Primary	Disease-free survival (DFS)	defined as the time from the beginning of randomization to recurrence or death due to disease progression	6 months
Secondary	the overall survival (OS)	defined as the time between enrollment in the study (i.e., ICF) and death from any cause.Subjects who survived the last contact were deleted on the last contact date	6 months
Secondary	Breast conserving rate	after neoadjuvant treatment, the percentage of patients undergoing breast conserving surgery in the total number of evaluable cases.	6 months