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Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Stages II-III Breast Cancer

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Trial Information

Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

This is a single center, open phase I dose escalation study. This study will assess the
highest tolerable dose of nab-paclitaxel (Abraxane) in combination with doxorubicin
(Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the
neoadjuvant setting. The objective is to primarily assess the safety of the drug
combination, and to secondarily obtain preliminary data on the clinical efficacy of the
combination. Up to 24 patients will be enrolled.

The study will test four dose levels of Abraxane as described in Table 2, with fixed dose of
doxorubicin (50 mg/m2 weekly) and cyclophosphamide (500 mg/m2). For each cycle, Abraxane
will be administered based on the dose schedule in Table 2. Adriamycin and Cyclophosphamide
will be given on day 1 and day 22 of each cycle. Each cycle will be repeated every 6 weeks.
The study will enroll patients with stages II-III, Her-2 negative breast cancer with no
prior therapy. Patients will be treated for 3 six-week cycles, for a total of 18 weeks.

Inclusion Criteria:

1. Histologically or cytologically proven adenocarcinoma of the breast stages II-III,
according to the AJCC Staging Manual, 6th Edition, 2002

2. Negative Her-2/neu status

3. ECOG performance status 0 or 1

4. Negative pregnancy test

5. Normal cardiac function (ejection fraction > lower limit of normal) as determined by
MUGA or echocardiogram

6. ANC greater than or equal to 1,500/mm3; platelet greater than or equal to
100,000/mm3; hemoglobin greater than or equal to 9 gm/dL

7. Serum bilirubin levels less than or equal to 1.5 mg/dL

8. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or
equal to 2.5 X upper limit of normal, alkaline phosphatase less than or equal to
2.5 X upper limit of normal.

9. Serum creatinine levels less than or equal to 1.5 mg/dL

10. Women of childbearing potential should be advised to avoid becoming pregnant and men
should be advised to not father a child while receiving treatment with azacitidine or
nab-paclitaxel. Appropriate methods of birth controls for women include oral or
implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide,
cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual
partner and also based on the judgment of the investigator.

11. Female, greater than or equal to 19 years of age and any race.

Exclusion Criteria:

1. Evidence of metastatic disease

2. Concurrent therapy with any other non-protocol anti-cancer therapy

3. Current therapy with hormone replacement therapy, or any hormonal agent such as
raloxifene, tamoxifen, or other selective estrogen receptor modulators

4. Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline

5. History of any other malignancy requiring active treatment

6. Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100],
myocardial infarction or stroke within 6 months, unstable angina), New York Heart
Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac
arrhythmia requiring medication

7. Currently active infection.

8. History of HIV infection or chronic hepatitis B or C.

9. The presence of any other medical or psychiatric disorder that, in the opinion of the
treating physician, would contraindicate the use of the drugs in this protocol or
place the subject at undue risk for treatment complications

10. Pregnancy or breast feeding

11. A history of a severe hypersensitivity reaction to nab-paclitaxel.

12. Any reason why, in the opinion of the investigator, the patient should not

Type of Study:


Study Design:

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

Outcome Measure:

Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Hung Khong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah


United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

November 2013

Related Keywords:

  • Stages II-III Breast Cancer
  • Breast Neoplasms



University of Utah Huntsman Cancer Institute Salt Lake City, Utah  84112