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Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)

Given the favorable activity demonstrated in a trial using the taxane docetaxel in
combination with cyclophosphamide, we propose a Phase II trial of 4 cycles of weekly nab
paclitaxel combined with cyclophosphamide. The favorable toxicity profile for weekly nab
paclitaxel, in addition to its demonstrated superiority over standard paclitaxel in
early-stage breast cancer, makes it an ideal taxane to evaluate in this setting. In this
study, nab paclitaxel will be administered once weekly, in combination with q3wk
cyclophosphamide. By using this combination therapy method, the goal of this study is to
maximize the opportunity to demonstrate improved tolerability of adjuvant nab paclitaxel
using a weekly dosing schedule in combination with q3wk cyclophosphamide.

In this study, patients who demonstrate FISH or IHC3+ HER2 positivity and adequate cardiac
function will also receive treatment with trastuzumab in addition to the nab paclitaxel /
cyclophosphamide combination therapy. Trastuzumab will be administered IV using an 8 mg/kg
loading dose on Day 1 of the treatment period. If no toxicity occurs, subsequent doses of
trastuzumab will be administered IV as a 6 mg/kg dose approximately every 21 days for a
total of 52 weeks (thus, maintenance therapy with trastuzumab will continue after the
12-week period of combination therapy with nab paclitaxel/cyclophosphamide/trastuzumab has

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability of Adjuvant Nab Paclitaxel Using Weekly Dosing Schedule Assessed by Patient Survival, Disease Recurrence, and Treatment-related Toxicity.

Outcome Time Frame:

18 Months

Safety Issue:


Principal Investigator

John Hainsworth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

September 2010

Related Keywords:

  • Breast Cancer
  • Early Stage Breast Cancer
  • Her2-positive
  • nab paclitaxel
  • cyclophosphamide
  • trastuzumab
  • Breast Neoplasms



Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Peninsula Cancer Institute Newport News, Virginia  23601
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Cancer Care of Western North Carolina Asheville, North Carolina  28801
Mercy Hospital Portland, Maine  04101
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
St. Louis Cancer Care Chesterfield, Missouri  63017
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Watson Clinic Center for Cancer Care and Research Lakeland, Florida  33805