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A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
carboplatin
Sponsored by
Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Triple negative breast cancer, adjuvant chemotherapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of breast cancer

    1. Female patients

    2. Histologically confirmed invasive breast cancer

      1. Primary tumor greater than 2cm diameter, measured by mammography and sonography
      2. Any N
    3. ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER <1%, PR<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+)
    4. No evidence of metastasis (M0)
    5. No prior hormonal, chemotherapy or radiotherapy is allowed.
    6. No breast operation other than biopsy to make diagnosis is allowed.
    7. Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
    8. Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
    9. Adequate renal function: Serum creatinine 1.5 mg/dl
    10. Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
    11. Written informed consent
    12. Normal mental function to understand and sign the consent
    13. Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
    14. LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment

Exclusion Criteria:

  1. Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
  2. Patients who underwent surgery for breast cancer
  3. Patients with a history of uncompensated congestive heart failure
  4. Patients with inflammatory breast cancer (T4d)
  5. Patients without primary tumor (T0)
  6. Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
  7. Known hypersensitivity to any of the study drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    carboplatin chemotherapy

    Observation arm

    Arm Description

    At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.

    In this observation arm, patients should be follow up with regular interval without treatment.

    Outcomes

    Primary Outcome Measures

    Disease-free survival (DFS)
    To compare DFS between carboplatin and observation within non-pCR (complete remission) patients

    Secondary Outcome Measures

    overall survival
    To compare overall survival (OS) between carboplatin and observation within non-pCR patients.
    pCR rate
    To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients.
    The percentage of patients who receive breast conserving surgery.
    To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients
    Number of adverse events
    Number of adverse events in patients with non-pCR.

    Full Information

    First Posted
    September 26, 2012
    Last Updated
    December 21, 2012
    Sponsor
    Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01752686
    Brief Title
    A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer
    Official Title
    A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Severance Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.
    Detailed Description
    In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals. In POST Neo-adjuvant period Randomization: At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Triple negative breast cancer, adjuvant chemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    587 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    carboplatin chemotherapy
    Arm Type
    Experimental
    Arm Description
    At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
    Arm Title
    Observation arm
    Arm Type
    No Intervention
    Arm Description
    In this observation arm, patients should be follow up with regular interval without treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin
    Other Intervention Name(s)
    Adding adjuvant arm
    Intervention Description
    carboplatin as adjuvant chemotherapy
    Primary Outcome Measure Information:
    Title
    Disease-free survival (DFS)
    Description
    To compare DFS between carboplatin and observation within non-pCR (complete remission) patients
    Time Frame
    up to 3 years
    Secondary Outcome Measure Information:
    Title
    overall survival
    Description
    To compare overall survival (OS) between carboplatin and observation within non-pCR patients.
    Time Frame
    up to 5years
    Title
    pCR rate
    Description
    To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients.
    Time Frame
    up to 3 years
    Title
    The percentage of patients who receive breast conserving surgery.
    Description
    To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients
    Time Frame
    up to 3years
    Title
    Number of adverse events
    Description
    Number of adverse events in patients with non-pCR.
    Time Frame
    up to 3years
    Other Pre-specified Outcome Measures:
    Title
    difference in gene expression pattern
    Time Frame
    up to 5 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of breast cancer Female patients Histologically confirmed invasive breast cancer Primary tumor greater than 2cm diameter, measured by mammography and sonography Any N ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER <1%, PR<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+) No evidence of metastasis (M0) No prior hormonal, chemotherapy or radiotherapy is allowed. No breast operation other than biopsy to make diagnosis is allowed. Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1) Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3 Adequate renal function: Serum creatinine 1.5 mg/dl Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal Written informed consent Normal mental function to understand and sign the consent Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment. LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment Exclusion Criteria: Patients who received hormonal, chemotherapy or radiotherapy for breast cancer Patients who underwent surgery for breast cancer Patients with a history of uncompensated congestive heart failure Patients with inflammatory breast cancer (T4d) Patients without primary tumor (T0) Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer Known hypersensitivity to any of the study drugs
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Byeong Woo Park, MD, PhD
    Phone
    82-2-2228-8125
    Email
    nobelg@yuhs.ac
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Byeong Woo Park, MD, PhD
    Organizational Affiliation
    Severance Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

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