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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01090128
First received: March 17, 2010
Last updated: July 28, 2014
Last verified: July 2014

March 17, 2010
July 28, 2014
September 2008
July 2015   (final data collection date for primary outcome measure)
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01090128 on ClinicalTrials.gov Archive Site
Overall clinical response rate (OcRR) [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stages II-III Breast Cancer
  • Drug: Nanoparticle Albumin Bound Paclitaxel
    IV administered over 30 minutes. The study will test four dose levels.
    Other Name: Abraxane
  • Drug: doxorubicin
    50 mg/m2 every 3 weeks
    Other Name: Adriamycin
  • Drug: cyclophosphamide
    500 mg/m2 given every 3 weeks
Experimental: All patients
All participants enrolled.
Interventions:
  • Drug: Nanoparticle Albumin Bound Paclitaxel
  • Drug: doxorubicin
  • Drug: cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
July 2015
July 2015   (final data collection date for primary outcome measure)

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 participate.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01090128
HCI53989
No
University of Utah
University of Utah
Celgene Corporation
Principal Investigator: Hung Khong, MD University of Utah
University of Utah
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP