Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab (PGH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jungsil Ro, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00532857
First received: September 19, 2007
Last updated: January 1, 2012
Last verified: January 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer

Resource links provided by NLM:


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) ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: March 2007
Study Completion Date: September 2011
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel/Gemcitabine/Trastuzumab Drug: Paclitaxel/Gemcitabine/Trastuzumab
80 mg/m2 of paclitaxel 1,200 mg/m2 of gemcitabine, day 1, day 8 every 3-week. trastuzumab at a dose of 4 mg/kg IV on D1 of first treatment cycle subsequently given weekly at a dose of 2 mg/kg
Other Names:
  • Paclitaxel
  • Gemzar
  • Herceptin

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532857

Locations
Korea, Republic of
National Cancer Center
809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
Jungsil Ro
Investigators
Principal Investigator: Jungsil Ro, MD,PhD National Cancer Center, Korea
  More Information

No publications provided by National Cancer Center, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jungsil Ro, Chief, Center for Clinical Trials, National Cancer Center, Korea, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00532857     History of Changes
Other Study ID Numbers: NCCCTS-06-235
Study First Received: September 19, 2007
Last Updated: January 1, 2012
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014