Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer

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

Details

• Lead Sponsor: William Sikov; William Sikov MD
• Collaborator: Yale University
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically documented adenocarcinoma of the breast

• ANC > 1000 cells

• Female; age > 18; Zubrod PS 0-1

• Platelets > 100,000

• Stage IIA-IIIB disease

• Total bilirubin < or = ULN

• No evidence of metastatic disease Not pregnant or lactating

• No prior systemic therapy for this breast cancer

• Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min

• Serum ALT < 2.5 x ULN

• ER, PR and HER2 status required

• LVEF (MUGA/echo)WNL

• No baseline > 2 neuropathy

• Hemoglobin > 9.0 gm/dl

• HER2+, defined by IHC 3+ or FISH ratio > 2.0