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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 (NAC)

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: September 26, 2016
Last verified: September 2016

March 17, 2010
September 26, 2016
September 2008
March 2020   (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 ]
  • Pathologic complete response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities [ Time Frame: one year ] [ Designated as safety issue: Yes ]
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 with expansion cohort. The dose escalation part of the study is now closed and the highest tolerable dose of nab-paclitaxel (Abraxane) was assessed to be 100 mg/m2 in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The initial phase I study objective was to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. 25 patients were enrolled. The expansion cohort will enroll 15 additional patients.

The purpose of the expansion cohort is to assess pathological complete response.

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. 100 mg/m2 on days 1 and 8
    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
27
March 2020
March 2020   (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, 7th Edition, 2009
  2. The following receptor status:

    Expansion: Triple negative (ER<1%, PR<1%, and Her-2/neu negative Phase 1 (closed): 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 while receiving treatment with nab-paclitaxel through 28 days after the last dose. 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. Concurrent therapy with any other non-protocol anti-cancer therapy
  2. For Phase I patients only: Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators
  3. Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline
  4. History of any other malignancy requiring active treatment
  5. 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
  6. Currently active infection.
  7. History of HIV infection or chronic hepatitis B or C.
  8. 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
  9. Pregnancy or breast feeding
  10. A history of a severe hypersensitivity reaction to nab-paclitaxel.
  11. Any reason why, in the opinion of the investigator, the patient should not participate.
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01090128
HCI53989
No
Not Provided
Not Provided
University of Utah
University of Utah
Celgene Corporation
Principal Investigator: Hung Khong, MD University of Utah
University of Utah
September 2016

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