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

NCT01090128 | Terminated Phase 1

• 1 other identifier: HCI53989
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Stages II-III Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities

  one year

• Pathologic complete response

  1 year

Secondary Outcomes (1)

• Overall clinical response rate (OcRR)

  one year

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Drug: Nanoparticle Albumin Bound Paclitaxel; Drug: doxorubicin; Drug: cyclophosphamide

Interventions

Nanoparticle Albumin Bound Paclitaxel DRUG

IV administered over 30 minutes. 100 mg/m2 on days 1 and 8

Also known as: Abraxane

All patients

doxorubicin DRUG

50 mg/m2 every 3 weeks

Also known as: Adriamycin

All patients

cyclophosphamide DRUG

500 mg/m2 given every 3 weeks

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Taxes; Albumin-Bound Paclitaxel; Doxorubicin; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Hung Khong, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: September 1, 2008
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)