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

Phase 2TerminatedNCT00532285

National Cancer Center, Korea44 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Paclitaxel/GemcitabineDRUG

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)

Time frame: two years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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