Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study.

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

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast cancer, with an interval between definitive breast surgery and study registration of <60 days.

• Definitive surgical treatment must be either mastectomy or breast-conserving therapy with axillary lymph node dissection for operable breast cancer (pT1 4 [including inflammatory breast cancer], pN0 3, and M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.

• Patients with ≥1 axillary lymph node containing metastatic adenocarcinoma measuring >0.2 mm, OR lymph node-negative patients with high-risk features

• Patients with HER2/neu positive or negative tumors (HER2 positivity must be documented by FISH positivity or IHC 3+).

• Patients who are to receive trastuzumab must have normal cardiac function (MUGA [cardiac ejection fraction >50%, or greater than or equal to the institutional lower limit of normal], or echocardiogram [ECHO] within institutional normal limits).

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.

• Patients who are either chemotherapy naïve, or who have received prior chemotherapy >5 years ago.

• Patients with previous invasive cancers (including breast cancer) eligible only if treated >5 years prior to entering this study, and show no evidence of recurrent disease.

• Adequate bone marrow function

• Adequate liver function,

• Adequate renal function,

• Patients of childbearing potential must use an effective method of contraception that is acceptable to their study physician from the time of signing informed consent until at least 3 months after the last dose of protocol treatment, and must have a negative pre study serum pregnancy test.

• Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria.

• MammoSite® brachytherapy radiation accepted when performed immediately following surgery and prior to receiving chemotherapy.

• Patients with bilateral, synchronous breast cancer, provided that one primary tumor meets the inclusion criteria.

Exclusion Criteria:

• Patients who are pregnant or breastfeeding.

• M1 metastatic disease.

• Patients requiring neoadjuvant chemotherapy.

• Life expectancy of greater than 6 months.

• History of cardiac disease, with a New York Heart Association (NYHA) Class II or greater CHF

• Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment, any history of stroke or transient ischemic attack at any time, clinically significant peripheral vascular disease, or evidence of a bleeding diathesis or coagulopathy.

• Any investigational agent within 30 days of receiving the first dose of study drug.

• Treatment with prior trastuzumab or bevacizumab therapy.

• Concurrent treatment with any other anti-cancer therapy is not permitted.

• History of significant psychiatric disorders.

• History of active, uncontrolled infection.

• A serious, non-healing wound, ulcer, or bone fracture.

• Any other diseases, metabolic dysfunction, findings from a physical examination, or clinical laboratory test results that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results or that renders the patient at high risk from treatment complications.