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

NCT00107094 | Completed Phase 1

• 1 other identifier: CA030
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Adriamycin; Cyclophosphamide; Abraxane

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

Abraxane DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (1)

Abraxis BioScience Inc.

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Hawkins, M.D.

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: March 1, 2005
• Last Updated: July 20, 2007

Record last verified: 2007-07

Locations

US (1)