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

June 22, 2011 updated by: National Cancer Center, Korea

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel/Gemcitabine
paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles
Drug: Paclitaxel/Gemcitabine
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.
Other Names:
  • Gemzar
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
two years

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

Investigators

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

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

September 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

August 1, 2009

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)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-05-150

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.

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