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Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab (PGH)
This study is currently recruiting participants.
Verified by National Cancer Center, Korea, September 2007
First Received: September 19, 2007   No Changes Posted
Sponsored by: National Cancer Center, Korea
Information provided by: National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00532857
  Purpose

To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)


Condition Intervention Phase
Breast Cancer
Drug: Paclitaxel, Gemcitabine,Trastuzumab
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride Trastuzumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • To evaluate the pathologic complete response rate To assess breast conserving rate after preoperative chemotherapy To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) To assess the safety profiles of PGH [ Time Frame: Prospective: a protocol that observes events in real time (may occur in the future) ]

Study Start Date: March 2007
Estimated Study Completion Date: December 2008
Intervention Details:
    Drug: Paclitaxel, Gemcitabine,Trastuzumab
    Paclitaxel, Gemcitabine,Trastuzumab
Detailed Description:

Primary objectives: To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH) Secondary objectives: To assess breast conserving rate after preoperative chemotherapyTo evaluate clinical response rate, disease free survival (DFS), and overall survival (OS) To assess the safety profiles of PGH

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) in addition to trastuzumab, which is given at a dose of 4 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given weekly at a dose of 2 mg/kg over 30 min. Patients will receive 6 cycles of therapy unless there is any evidence of no response suitable for operation(SD or PD) or unacceptable toxicity or noncompliance by patient with protocol requirements. Patients who are unsuitable for op due to SD or PD, will undergo XRT.

However, when patients are still suitable for op even with SD or PD, these patients will undergo op.Such decision will be made at physician's discretion at each institution. Also, even though there is neither clear evidence of disease progression nor severe toxicity, if patient declines the treatment, study treatment can be discontinued. Response will be documented by physical examination, sonography and/or chest CT prior to treatment and every three cycles. Postoperatively within 1-3 week, trastuzumab 6 mg/kg every 3 weeks x 11 and tamoxifen or AI for 5 years will be given as indicated. Radiation therapy will be initiated postoperatively in 3-4 weeks according to the standard practice guidelines.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have histologically confirmed and newly diagnosed operable breast cancer
  • HER2 positive (all FISH +)
  • Axillary node positive (by PET or cytologically determine node by sonography) and/or tumor size > 5 cm -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: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function:

    1. normal or nonspecific EKG taken within 1 mo of enrollment
    2. LVEF ³ 50% by MUGA or Echocardiogram taken within 1 mo of enrollment
  • Normal 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 a history of uncompensated congestive heart failure
  • Patients with node-negative stage IIA (T2N0) breast cancer
  • Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532857

Contacts
Contact: Jungsil Ro, M.D. 82-31-920-1228 jungsro@ncc.re.kr
Contact: Keunseok Lee, M.D

Locations
Korea, Republic of, Gyeonggi-do
National Cancer Center Recruiting
809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Jungsil Ro, MD     82-31-920-1610     jungsro@ncc.re.kr    
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jungsil Ro, MD,PhD National Cancer Center, Korea
  More Information

No publications provided

Study ID Numbers: NCCCTS-06-235
Study First Received: September 19, 2007
Last Updated: September 19, 2007
ClinicalTrials.gov Identifier: NCT00532857     History of Changes
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
Patients with HER2 + stage II/III breast cancer

Study placed in the following topic categories:
Antimetabolites
Skin Diseases
Immunologic Factors
Breast Neoplasms
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Trastuzumab
Gemcitabine
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Therapeutic Uses
Trastuzumab
Gemcitabine
Breast Diseases
Skin Diseases
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009