Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer - Full Text View

Sponsored by:	National Cancer Center, Korea
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00532285

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 Primary	Drug: Paclitaxel, Gemcitabine	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

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

Estimated Enrollment:

44

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

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

Study ID Numbers:	NCCCTS-05-150
Study First Received:	September 19, 2007
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00532285
Health Authority:	Republic of Korea: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Breast Neoplasms
Gemcitabine
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009