Clinical Trials /

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

NCT01090128

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: HCI53989
  • NCT ID: NCT01090128

Conditions

  • Stages II-III Breast Cancer

Interventions

DrugSynonymsArms
Nanoparticle Albumin Bound PaclitaxelAbraxaneAll patients
doxorubicinAdriamycinAll patients
cyclophosphamideAll patients

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
All patientsExperimentalAll participants enrolled.
  • Nanoparticle Albumin Bound Paclitaxel
  • doxorubicin
  • cyclophosphamide

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities
Time Frame:one year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall clinical response rate (OcRR)
Time Frame:one year
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:University of Utah

Last Updated

March 29, 2017