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

This study has been terminated.
(terminated)
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00532285
First received: September 19, 2007
Last updated: June 22, 2011
Last verified: September 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Paclitaxel/Gemcitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG) [ Time Frame: two years ] [ Designated as safety issue: No ]

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 [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: September 2005
Study Completion Date: August 2009
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Paclitaxel
  • Gemzar

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532285

Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jungsil Ro, MD, PhD National Cancer Center
  More Information

No publications provided

Responsible Party: CENTER FOR BREAST CANCER, NATIONAL CANCER CENTER
ClinicalTrials.gov Identifier: NCT00532285     History of Changes
Other Study ID Numbers: NCCCTS-05-150
Study First Received: September 19, 2007
Last Updated: June 22, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on May 21, 2013