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 currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Utah
Celgene Corporation
Information provided by (Responsible Party):
University of Utah Identifier:
First received: March 17, 2010
Last updated: March 17, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Stages II-III Breast Cancer
Drug: Nanoparticle Albumin Bound Paclitaxel
Drug: doxorubicin
Drug: cyclophosphamide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Overall clinical response rate (OcRR) [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled.
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

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 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. Concurrent therapy with any other non-protocol anti-cancer therapy
  2. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01090128

Contact: Lizzy Constantz 801-587-4567

United States, Utah
University of Utah Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Lizzy Constantz    801-587-4567   
Principal Investigator: Hung T Khong, MD         
Sponsors and Collaborators
University of Utah
Celgene Corporation
Principal Investigator: Hung Khong, MD University of Utah
  More Information

Responsible Party: University of Utah Identifier: NCT01090128     History of Changes
Other Study ID Numbers: HCI53989 
Study First Received: March 17, 2010
Last Updated: March 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Albumin-Bound Paclitaxel
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on May 26, 2016