Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00107094
First received: April 5, 2005
Last updated: July 18, 2007
Last verified: July 2007
  Purpose

In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Abraxane
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Pilot Study of Dose-Dense Adriamycin Plus Cyclophosphamide (AC) Followed by ABI-007 as Adjuvant Therapy for Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Safety/tolerability endpoints:
  • incidence of treatment-emergent/related adverse events and serious adverse events
  • laboratory abnormalities
  • nadir of myelosuppression
  • incidence of patients experiencing dose modifications, dose interruptions, and/or premature discontinuation of study drug

Estimated Enrollment: 30
Study Start Date: March 2005
Detailed Description:

This is an open-label, pilot study to evaluate the safety of Adriamycin and cyclophosphamide (AC) administered every 2 weeks for 4 cycles followed by Abraxane administered every 2 weeks for 4 cycles as adjuvant therapy for patients with limited stage breast cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient will be eligible for inclusion in this study only if all of the following criteria are met:

  • Estrogen Receptor (ER) and Progesterone Receptor (PR) status have been determined
  • Operable, histologically confirmed adenocarcinoma of the breast
  • Must meet 1 of the following criteria:

    • T1-3, N1-2, M0, regardless of ER or PR status;
    • T >2 cm, N0, M0, regardless of ER or PR status;
    • T >1 cm, N0, M0 and both ER and PR negative;
    • T1-2 and 1 sentinel node with micrometastasis <2 mm with or without axillary dissection, M0;
    • T1-2 and >1 sentinel node micrometastasis or 1 node with a macrometastasis >2 mm and/or T3 must have axillary dissection, M0.
  • Negative surgical margins to lumpectomy or mastectomy specimen (no ink on invasive cancer and no ink on DCIS [ductal carcinoma in situ]).
  • ECOG performance status 0-1
  • Adequate wound healing, as determined by the treating physician
  • It has not been longer than 84 days since the date of definitive surgery (e.g.,mastectomy or, in the case of a breast-sparing procedure, axillary dissection).
  • Previous invasive cancers if treated >5 years prior to entering this study, except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, the latter are not required to have occurred more than 5 years prior to study entry.
  • Prior invasive breast cancer if diagnosed >5 years prior to entering study. Patients must have finished adjuvant hormonal therapy prior to registration. Patients with prior DCIS are eligible. Patients with DCIS who were treated with tamoxifen must have finished tamoxifen prior to registration.
  • Laboratory values must be as follows:

    • White blood cell count: ≥3,000/mm3;
    • Absolute neutrophil count: ≥1,500/mm3;
    • Platelets: ≥100,000/mm3;
    • Hemoglobin: ≥8 g/dL;
    • Bilirubin: ≤ the institution’s ULN (upper limit of normal);
    • Creatinine: ≤1.5 mg/dL;
    • Calculated creatinine clearance >30 mL/min;
    • AST and ALT and alkaline phosphatase may be up to 2.5 × institutional ULN.
  • All staging studies including physical exam, chest x-ray, and bone scan must show no evidence of metastatic disease, including suspicious lymphadenopathy or skin nodules on physical exam. A chest x-ray and bone scan are mandatory; however, all other staging studies are at the treating physician’s discretion. Any other staging test (e.g., CT scans, MRI studies, ultrasound of abdomen, PET scans) must be negative for metastatic disease. An abdominal CT scan or PET scan is mandatory for patients with liver function tests elevated above the ULN to rule out metastatic disease.
  • Patient has a negative serum pregnancy test within 10 days prior to registration (patients of childbearing potential).
  • If fertile, patient has agreed to use an acceptable method of birth control to avoid pregnancy [Note: oral contraceptives are not allowed] for the duration of the study.
  • Patient has signed a Patient Informed Consent Form

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

  • Any evidence of disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease.
  • Stage IIIb breast cancer (T4 disease, i.e., patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).
  • Stage IV breast cancer.
  • Prior anthracycline, anthracenedione (mitoxantrone), or taxane therapy.
  • Neoadjuvant therapy for this breast cancer.
  • Peripheral neuropathy >Grade 1.
  • Serious medical illness, other than that treated by this study, which would limit survival to <2 years, or psychiatric condition that would prevent informed consent.
  • Uncontrolled or severe cardiovascular disease including recent (<6 months) myocardial infarction, or congestive heart failure.
  • Active uncontrolled bacterial, viral (including clinically defined AIDS), or fungal infection.
  • Patients with active hepatitis with abnormal LFTs (liver function tests) or patients who are known to be HIV positive
  • Uncontrolled disease such as uncontrolled diabetes
  • Obese patient to whom the Investigator is not comfortable administering full doses of study drugs as calculated by the BSA (body surface area).
  • Patients receiving concurrent immunotherapy.
  • A history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of high-risk breast cancer.
  • Patient has had an organ allograft.
  • Patient is pregnant or breastfeeding.
  • Patient is unable to comply with study requirements.
  • Patient is receiving any investigational drugs.
  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 ClinicalTrials.gov identifier: NCT00107094

Locations
United States, North Carolina
Abraxis BioScience Inc.
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Michael Hawkins, M.D. Celgene Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00107094     History of Changes
Other Study ID Numbers: CA030
Study First Received: April 5, 2005
Last Updated: July 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Breast Cancer
Adriamycin
Cyclophosphamide
Abraxane

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Paclitaxel
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014