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

January 1, 2012 updated by: Jungsil Ro

Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • 809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Herceptin
  • Gemzar
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Prospective: a protocol that observes events in real time (may occur in the future)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jungsil Ro

Investigators

  • Principal Investigator: Jungsil Ro, MD,PhD, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2012

Last Update Submitted That Met QC Criteria

January 1, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-06-235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe