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

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ClinicalTrials.gov Identifier: NCT03959397
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Aiping shi, Jilin University

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959397


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
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Study Director: Fan zhimin, Doctor First Affiliated Hospital of Jilin University
More Information
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Publications:

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Responsible Party: Aiping shi, Chief physician and associate professor, Jilin University
ClinicalTrials.gov Identifier: NCT03959397    
Other Study ID Numbers: CSPC-KAL-BC-12
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aiping shi, Jilin University:
Breast cancer; neoadjuvant therapy; Nab-paclitaxel
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action