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A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel


OBJECTIVES:

Primary

- Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and
cyclophosphamide and/or paclitaxel in women with nonmetastatic invasive breast cancer.

- Determine treatment-induced myelosuppression (e.g., neutropenia) in patients treated
with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug
activation and metabolism genes.

- Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in
patients treated with paclitaxel.

Secondary

- Determine response (i.e., relapse in the adjuvant setting) during a 10-year follow-up
period in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients receive treatment on CALGB-40101 OR are
assigned to receive 1 of 2 treatment regimens on this study.

- Regimen 1: Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over
30 minutes on day 1. Treatment repeats every 21 days for 4 courses.

- Regimen 2: Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients
then receive paclitaxel IV over 1 hour once weekly for 12 weeks.

After completion of study treatment, patients are followed at 3, 6, and 12 months and then
annually for up to 10 years.

PROJECTED ACCRUAL: A total of 500 patients (300 treated with doxorubicin and
cyclophosphamide and 200 treated with paclitaxel) will be accrued for this study within 3-4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:

- Node negative disease AND meets 1 of the following stage criteria:

- Primary tumor > T1c

- Primary tumor > T1b AND poor prognostic features, defined as the following:

- High-grade disease

- HER2/neu-positive disease by fluorescence in situ hybridization

- Estrogen receptor-negative disease

- Stage II disease (T2, N0)

- Node positive nonmetastatic disease

- Locally advanced disease AND receiving neoadjuvant chemotherapy comprising
doxorubicin and cyclophosphamide OR paclitaxel

- Enrolled in clinical trial CALGB-40101

- No evidence of systemic metastasis

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin < 2.0 times upper limit of normal

Renal

- Creatinine < 2.0 mg/dL

Cardiovascular

- No ischemic heart disease

- No uncontrolled hypertension

Other

- Not pregnant

- No poorly controlled diabetes mellitus

- No active infection

- No peripheral neuropathy ≥ grade 2

- No other serious comorbidity

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent anticancer immunotherapy or biologic response modifiers

- No concurrent growth factors during course 1 of doxorubicin and cyclophosphamide
study treatment

Chemotherapy

- See Disease Characteristics

- No prior weekly paclitaxel

Endocrine therapy

- No concurrent anticancer endocrine therapy

Radiotherapy

- Concurrent radiotherapy to the chest wall allowed for patients receiving paclitaxel
only

Surgery

- At least 2 weeks since prior major surgery (e.g., wide excision, lumpectomy, or
mastectomy)

Other

- More than 2 weeks since prior and no concurrent CYP450 inducers or inhibitors

- No other concurrent anticancer cytotoxic therapy

- No other concurrent investigational drugs

- No other concurrent medications known to cause myelosuppression (e.g., neutropenia)
or neuropathy

- No concurrent participation in another clinical trial except for patients receiving
adjuvant doxorubicin and cyclophosphamide on protocols CALGB-40101 or MA-21

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacogenomics of doxorubicin, cyclophosphamide, and paclitaxel

Safety Issue:

No

Principal Investigator

Paul K. Marcom, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke Cancer Institute

Authority:

Unspecified

Study ID:

CDR0000438673

NCT ID:

NCT00131963

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IB breast cancer
  • Breast Neoplasms

Name

Location

Duke Cancer InstituteDurham, North Carolina  27710