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Gene Expression Profiles of Breast Cancer Treated With Sequential Adriamycin and Docetaxel in Relation to Tumor Responses

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

Gene Expression Profiles of Breast Cancer Treated With Sequential Adriamycin and Docetaxel in Relation to Tumor Responses

Significant inter-individual variation exists in tumor response and chemotherapy toxicity
because of unique tumor and patient factors. Individual drugs with distinct mechanisms of
action may induce specific genomic and proteomic changes that may be used as predictor for
response. We plan to study serial genomic and proteomic profiles in primary breast tumor
treated with one of two sequences of alternating adriamycin (A) and docetaxel (T),
A>T>A>T>A>T, or T>A>T>A>T>A, at 75mg/m2 3 weekly for each drug. Pharmacokinetic analysis of
both drugs will be performed; amplified tumor RNA will be hybridized on Affymetrix®
HG-U133+2 array; tumor proteins will be fractionated and profiled with ProteinChip® Array
SELDI MS (Ciphergen). Tumor gene expression and proteomic changes will be correlated with
treatment response to identify biomarkers that may predict chemotherapy sensitivity.

Inclusion Criteria:

- Female, age > 18 years.

- Histologic or cytologic diagnosis of breast carcinoma.

- Stage II to IV breast cancer with measurable primary breast tumor, defined as
palpable tumor with both diameters 2.0cm or greater as measured by caliper.

- Patients must not have received prior chemotherapy or hormonal therapy for the
treatment of breast cancer.

- Karnofsky performance status of 70 or higher.

- Estimated life expectancy of at least 12 weeks.

- Adequate organ function including the following:

- Bone marrow: White blood cells (WBC) >= 3.5 x 109/L Absolute neutrophil (segmented
and bands) count (ANC) >= 1.5 x 109/L Platelets >= 100 x 109/L Haemoglobin >= 9g/dL

- Hepatic: Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN,
(or <=5 X with liver metastases) Alkaline phosphatase <= 2.5x ULN.

- Renal: creatinine <= 1.5x ULN

- Cardiac:

- Adequate cardiac function

- Signed informed consent from patient or legal representative.

- Patients with reproductive potential must use an approved contraceptive method if
appropriate (eg, intrauterine device, birth control pills, or barrier device) during
and for three months after the study. Females with childbearing potential must have a
negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

- Prior treatment for locally advanced or metastatic breast cancer.

- Treatment within the last 30 days with any investigational drug.

- Concurrent administration of any other tumor therapy, including cytotoxic
chemotherapy, hormonal therapy, and immunotherapy.

- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy.

- Pregnancy.

- Breast feeding.

- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the

- Poorly controlled diabetes mellitus.

- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.

- Symptomatic brain metastasis.

- History of significant neurological or mental disorder, including seizures or

- Peripheral neuropathy of >= CTC grade 2.

- History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for
commercial docetaxel formulations.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1. Evaluate the impact of adriamycin and docetaxel on tumor gene expression profiles.

Principal Investigator

Soo-Chin Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Singapore: Health Sciences Authority

Study ID:

HO B17/02



Start Date:

April 2002

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • chemotherapy response
  • gene expression profiles
  • proteomics
  • Breast Neoplasms