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Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel/Gemcitabine
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • All patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage IIA and any stage IIB, III. PET results will determine node positivity. If PET was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration.
  • No prior hormonal, chemotherapy or radiotherapy is allowed.
  • No breast operation other than biopsy to make diagnosis is allowed.
  • Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
  • Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3
  • Adequate renal function: Serum creatinine £ 1.5 mg/dl
  • Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ two times normal, Alkaline phosphatase: £ two times normal
  • Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
  • Adequate mental function to understand and sign the consent

Exclusion Criteria:

  • Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
  • Patients who underwent surgery for breast cancer
  • Patients with node-negative stage IIA breast cancer
  • Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paclitaxel/Gemcitabine

    Arm Description

    paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles

    Outcomes

    Primary Outcome Measures

    To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)

    Secondary Outcome Measures

    To assess breast conserving rate To evaluate the disease free survival (DFS) and overall survival (OS) of patients who received preoperatively PG To investigate the toxicity profiles of PG

    Full Information

    First Posted
    September 19, 2007
    Last Updated
    June 22, 2011
    Sponsor
    National Cancer Center, Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00532285
    Brief Title
    Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
    Official Title
    Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Terminated
    Why Stopped
    terminated
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    April 2006 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Cancer Center, Korea

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open labeled phase II single arm trial. The patients with clinical stage II and III will undergo core-needle biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu and others. PET or ultrasound results will determine the positivity of lymph node metastasis.
    Detailed Description
    Patients will be treated as follows: PG x 4®operation®AC x 4®radiation ± tamoxifen/AI(postmenopausal) Intravenous infusion of Paclitaxel 80 mg/m2, over 60 min, on D1 and D8 Followed by intravenous infusion of Gemcitabine 1200 mg/m2, over 30 min, on D1 and D8 The cycle repeats every 3 weeks for 4 times. Premedication includes antiemetics, dexamethasone, famotidine, pheniramine as routinely given. After the operation, standard adjuvant chemotherapy (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2, every 3 weeks x 4 cycles) will be given.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paclitaxel/Gemcitabine
    Arm Type
    Experimental
    Arm Description
    paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel/Gemcitabine
    Other Intervention Name(s)
    Paclitaxel, Gemzar
    Intervention Description
    Treatment will be delivered in the outpatient setting. Each three-week cycle consists of paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8).Patients will receive four cycles of therapy unless there is any evidence of no response (SD or PD) or unacceptable toxicity defined as unpredictable, irreversible, or Grade 4, or noncompliance by patient with protocol requirements.
    Primary Outcome Measure Information:
    Title
    To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)
    Time Frame
    two years
    Secondary Outcome Measure Information:
    Title
    To assess breast conserving rate To evaluate the disease free survival (DFS) and overall survival (OS) of patients who received preoperatively PG To investigate the toxicity profiles of PG
    Time Frame
    two years

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage IIA and any stage IIB, III. PET results will determine node positivity. If PET was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration. No prior hormonal, chemotherapy or radiotherapy is allowed. No breast operation other than biopsy to make diagnosis is allowed. Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1) Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3 Adequate renal function: Serum creatinine £ 1.5 mg/dl Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ two times normal, Alkaline phosphatase: £ two times normal Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment Adequate mental function to understand and sign the consent Exclusion Criteria: Patients who received hormonal, chemotherapy or radiotherapy for breast cancer Patients who underwent surgery for breast cancer Patients with node-negative stage IIA breast cancer Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jungsil Ro, MD, PhD
    Organizational Affiliation
    National Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

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