Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jungsil Ro
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• All patients must have histologically confirmed and newly diagnosed operable breast cancer

• HER2 positive (all FISH +)

• Axillary node positive (by PET or cytologically determine node by sonography) and/or tumor size > 5 cm -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: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function:

1. normal or nonspecific EKG taken within 1 mo of enrollment

2. LVEF ³ 50% by MUGA or Echocardiogram taken within 1 mo of enrollment

• Normal 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 a history of uncompensated congestive heart failure

• Patients with node-negative stage IIA (T2N0) breast cancer

• Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer