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

NCT03959397 | Unknown Phase 2

• 1 other identifier: CSPC-KAL-BC-12
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Stage

Keywords

Breast cancer; neoadjuvant therapy; Nab-paclitaxel

Outcome Measures

Primary Outcomes (2)

• 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

• Disease-free survival (DFS)

  defined as the time from the beginning of randomization to recurrence or death due to disease progression

  6 months

Secondary Outcomes (2)

• the overall survival (OS)

  6 months

• Breast conserving rate

  6 months

Other Outcomes (1)

• Adverse events (AE)

  6 months

Study Arms (1)

nab-paclitaxel

EXPERIMENTAL

nab-paclitaxel monotherapy or combination therapeutic regimen

Drug: nab-paclitaxel

Interventions

nab-paclitaxel DRUG

nab-paclitaxel monotherapy or combination therapeutic regimen

Also known as: ABRAXANE ，Albumin-binding paclitaxel

nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Allergy to paclitaxel for injection (albumin binding) and/or its adjuvants has been demonstrated;
• Pregnant or lactating women
• 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
• Paclitaxel for injection (albumin binding type) contraindications in patients
• Participating in clinical trials of other taxoids
• Patients with concomitant other tumors, other than cured carcinoma in situ of the cervix and non-melanoma skin cancer
• Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
• The researchers considered that there were other conditions that were not suitable for enrollment.

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

the first hospital of Jilin University

Jilin, Changchun, 130021, China

Location

Related Publications (4)

• Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel 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 Gynakologische 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):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8.

  PMID: 26869049 BACKGROUND

• 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.

  PMID: 29228315 BACKGROUND

• 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.

  PMID: 28061451 BACKGROUND

• 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.

  PMID: 27393622 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fan zhimin, Doctor

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Fan zhimin, Doctor

CONTACT

13904321567; 13364308696@163.com

Shi aiping

CONTACT

15804301451; 13364308696@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician and associate professor

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 22, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2024
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)