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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)

Primary Purpose

Stages II-III Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nanoparticle Albumin Bound Paclitaxel
doxorubicin
cyclophosphamide
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stages II-III Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Utah Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

All participants enrolled.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall clinical response rate (OcRR)

Full Information

First Posted
March 17, 2010
Last Updated
March 29, 2017
Sponsor
University of Utah
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01090128
Brief Title
Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
Acronym
NAC
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Drug Manufacturer withdrew support for studies not in metastatic breast cancer
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 24, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stages II-III Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Arm Description
All participants enrolled.
Intervention Type
Drug
Intervention Name(s)
Nanoparticle Albumin Bound Paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
IV administered over 30 minutes. 100 mg/m2 on days 1 and 8
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
50 mg/m2 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
500 mg/m2 given every 3 weeks
Primary Outcome Measure Information:
Title
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities
Time Frame
one year
Title
Pathologic complete response
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall clinical response rate (OcRR)
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven adenocarcinoma of the breast stages II-III, according to the AJCC Staging Manual, 7th Edition, 2009 The following receptor status: Expansion: Triple negative (ER<1%, PR<1%, and Her-2/neu negative Phase 1 (closed): Negative Her-2/neu status ECOG performance status 0 or 1 Negative pregnancy test Normal cardiac function (ejection fraction > lower limit of normal) as determined by MUGA or echocardiogram 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 Serum bilirubin levels less than or equal to 1.5 mg/dL 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. Serum creatinine levels less than or equal to 1.5 mg/dL 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. Female, greater than or equal to 19 years of age and any race. Exclusion Criteria: Concurrent therapy with any other non-protocol anti-cancer therapy 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 Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline History of any other malignancy requiring active treatment 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 Currently active infection. History of HIV infection or chronic hepatitis B or C. 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 Pregnancy or breast feeding A history of a severe hypersensitivity reaction to nab-paclitaxel. Any reason why, in the opinion of the investigator, the patient should not participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung Khong, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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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

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