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Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abraxane
Xeloda
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring neoadjuvant chemotherapy, Abraxane, Xeloda

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Provision of informed consent
  2. Women and men at least 18 years of age or older.
  3. Pathological confirmation of breast cancer
  4. Tumor stage(TNM):T2-4N0-3M0
  5. No evidence of distant metastasis
  6. Adequate bone marrow, hepatic, and renal function
  7. Measurable disease as per RECIST criteria
  8. Karnofsky≥70
  9. Laboratory criteria:

PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2*ULN

Exclusion Criteria:

  1. Presence of metastatic disease.
  2. Inflammatory breast cancer.
  3. Bilateral breast cancer.
  4. previous chemotherapy or hormonal therapy for current breast neoplasm.
  5. other malignant tumors (concurrent or previous).
  6. Pregnant woman.
  7. Hypersensitive to any drug in Abraxane or Xeloda regimen or any ingredient of Abraxane or Xeloda.
  8. Any severe systemic disease contraindicating chemotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Abraxane Combined With Xeloda

    Arm Description

    Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.

    Outcomes

    Primary Outcome Measures

    ORR(CR+PR)
    To evaluate the efficacy of concurrent Abraxane and Xeloda as neoadjuvant regimen in terms of: ORR(CR+PR), downstaging rates in tumor size and axillary lymph node. Pathological Complete Response(pCR) defined by: defined as ypT0, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).

    Secondary Outcome Measures

    Side Effects.
    Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on.
    Event Free Survival(DFS)
    Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
    Overall Survival(OS)
    Time from the first dose of Abraxane and Xeloda to death due to any cause

    Full Information

    First Posted
    June 10, 2018
    Last Updated
    December 6, 2018
    Sponsor
    Zhejiang Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03647514
    Brief Title
    Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer
    Official Title
    A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Operable Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2018 (Anticipated)
    Primary Completion Date
    September 30, 2020 (Anticipated)
    Study Completion Date
    September 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zhejiang Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment for breast cancer. The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane (125mg/m2) Combined With Q3week Xeloda (1250mg/m2) in early operable (stage of T2-4N0-3M0) breast cancer. This study will be an open label non randomized, single arm, single center study.
    Detailed Description
    The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is feasible and achieves high response rates. It is proposed that 50 patients will be enrolled in this study. The target population is women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic therapy. The primary objective of the trial is to determine the overall response rate. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    neoadjuvant chemotherapy, Abraxane, Xeloda

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Abraxane Combined With Xeloda
    Arm Type
    Experimental
    Arm Description
    Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Abraxane
    Intervention Description
    Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Xeloda
    Intervention Description
    Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
    Primary Outcome Measure Information:
    Title
    ORR(CR+PR)
    Description
    To evaluate the efficacy of concurrent Abraxane and Xeloda as neoadjuvant regimen in terms of: ORR(CR+PR), downstaging rates in tumor size and axillary lymph node. Pathological Complete Response(pCR) defined by: defined as ypT0, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).
    Time Frame
    Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment
    Secondary Outcome Measure Information:
    Title
    Side Effects.
    Description
    Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on.
    Time Frame
    First Dose of Abraxane and Xeloda up to 24 months
    Title
    Event Free Survival(DFS)
    Description
    Time of surgery to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
    Time Frame
    Time of Surgery up to 5 years
    Title
    Overall Survival(OS)
    Description
    Time from the first dose of Abraxane and Xeloda to death due to any cause
    Time Frame
    First Dose of Abraxane and Xeloda up to 5 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Provision of informed consent Women and men at least 18 years of age or older. Pathological confirmation of breast cancer Tumor stage(TNM):T2-4N0-3M0 No evidence of distant metastasis Adequate bone marrow, hepatic, and renal function Measurable disease as per RECIST criteria Karnofsky≥70 Laboratory criteria: PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2*ULN Exclusion Criteria: Presence of metastatic disease. Inflammatory breast cancer. Bilateral breast cancer. previous chemotherapy or hormonal therapy for current breast neoplasm. other malignant tumors (concurrent or previous). Pregnant woman. Hypersensitive to any drug in Abraxane or Xeloda regimen or any ingredient of Abraxane or Xeloda. Any severe systemic disease contraindicating chemotherapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ding Xiaowen, Doc
    Phone
    +86 13588054604
    Email
    dingxw@zjcc.org.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ding Yuqin
    Phone
    +86 13588255651
    Email
    13588255651@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ding Xiaowen, Doc
    Organizational Affiliation
    Zhejiang Cancer Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Abraxane Combined With Xeloda as Neo-Adjuvant Chemotherapy in Early Breast Cancer

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