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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT00617942

Run by

William Sikov MD

People needed

60

Starts

2008-02-01

Expected to finish

2015-12-01

Last updated by the study team

2020-06-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States
• Yale Smilow Cancer Center — New Haven, Connecticut, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Roger Williams Medical Center — Providence, Rhode Island, United States
• Rhode Island and The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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