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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Paclitaxel/Gemcitabine

• Registration Number: NCT00532285
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

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 Timeline

• Study Start: 2005-09
• Primary Completion: 2006-04
• Status Verified: 2007-09
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-20
• Study Completion: 2009-08
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel/Gemcitabine	Paclitaxel/Gemcitabine	paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles

Primary Outcome Measures

Name	Time	Method
To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)	two years

Secondary Outcome Measures

Name	Time	Method
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	two years