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出境医 / 临床实验 / Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Stage Drug: nab-paclitaxel Phase 2

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Real-world Study of Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: nab-paclitaxel
nab-paclitaxel monotherapy or combination therapeutic regimen
 Drug: nab-paclitaxel
nab-paclitaxel monotherapy or combination therapeutic regimen
Other Name: ABRAXANE ，Albumin-binding paclitaxel
Outcome Measures
Primary Outcome Measures :
  1. the Pathological complete remission(pCR) [ Time Frame: 2 weeks ]
    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. Disease-free survival (DFS) [ Time Frame: 6 months ]
    defined as the time from the beginning of randomization to recurrence or death due to disease progression


Secondary Outcome Measures :
  1. the overall survival (OS) [ Time Frame: 6 months ]
    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

  2. Breast conserving rate [ Time Frame: 6 months ]
    after neoadjuvant treatment, the percentage of patients undergoing breast conserving surgery in the total number of evaluable cases.


Other Outcome Measures:
  1. Adverse events (AE) [ Time Frame: 6 months ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Fan zhimin, Doctor 13904321567 13364308696@163.com
Contact: Shi aiping 15804301451 13364308696@163.com

Locations
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China, Changchun
the first hospital of Jilin University
Jilin, Changchun, China, 130021
Sponsors and Collaborators
Jilin University
Investigators
Layout table for investigator information
Study Director: Fan zhimin, Doctor First Affiliated Hospital of Jilin University
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • the Pathological complete remission(pCR) [ Time Frame: 2 weeks ]
    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.
  • Disease-free survival (DFS) [ Time Frame: 6 months ]
    defined as the time from the beginning of randomization to recurrence or death due to disease progression
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • the overall survival (OS) [ Time Frame: 6 months ]
    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
  • Breast conserving rate [ Time Frame: 6 months ]
    after neoadjuvant treatment, the percentage of patients undergoing breast conserving surgery in the total number of evaluable cases.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2019) 		Adverse events (AE) [ Time Frame: 6 months ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer
Official Title  ICMJE A Real-world Study of Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer Stage
Intervention  ICMJE Drug: nab-paclitaxel
nab-paclitaxel monotherapy or combination therapeutic regimen
Other Name: ABRAXANE ，Albumin-binding paclitaxel
Study Arms  ICMJE Experimental: nab-paclitaxel
nab-paclitaxel monotherapy or combination therapeutic regimen
Intervention: Drug: nab-paclitaxel
Publications *
  • 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):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8. Erratum in: Lancet Oncol. 2016 Jul;17 (7):e270.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fan zhimin, Doctor 13904321567 13364308696@163.com
Contact: Shi aiping 15804301451 13364308696@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959397
Other Study ID Numbers  ICMJE CSPC-KAL-BC-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aiping shi, Jilin University
Study Sponsor  ICMJE Jilin University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fan zhimin, Doctor First Affiliated Hospital of Jilin University
PRS Account Jilin University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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