A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel
Completed
Conditions studied: Breast Cancer
In brief
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or paclitaxel work in treating women with nonmetastatic breast cancer.
Key facts
- Study ID
- NCT00131963
- Run by
- Duke University
- People needed
- 94
- Starts
- 2003-10-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2016-07-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- Other anticancer cytotoxic or endocrine therapy, immunotherapy, or biologic response modifiers,Study Drugs or other concomitant medications known to cause myelosuppression especially neutropenia and neuropathy
- Eastern Cooperative Oncology Group Performance Status(ECOG) functional status > 2.
- Serious co-morbidities including poorly controlled diabetes mellitus, ischaemic heart disease,uncontrolled hypertension or active infection.
- Pregnancy
- Use of growth factor during cycle 1 of chemotherapy (AC) under pharmacokinetic evaluation
- Grade >/=2 peripheral neuropathy symptoms based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) Scale. Exception: a chronic neurologic disorder will be reviewed on a case by case basis by the study PI.
- Prior treatment with weekly paclitaxelDISEASE 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
- Human Epidermal Growth Factor Receptor 2 (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
Where it is running
- Duke Cancer Institute — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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