Overview

CYP2D6 Genotype on the Clinical Effect of Tamoxifen

Status:
Unknown status
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical effects of tamoxifen using with samples from prospective randomized multicenter study(ASTRRA).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korea University Anam Hospital
Collaborators:
Korean Breast Cancer Study Group
National Cancer Center, Korea
Treatments:
Tamoxifen
Criteria
Inclusion Criteria:

- The patient must sign the informed consent form.

- The patient must sign the informed consent of genotype screening test.

- The patient must be between 18 years old and 45 years old who can make a decision
independently.

- Patients must have undergone excision of the primary breast mass, proven
histologically to be invasive breast adenocarcinoma.(The type of mastectomy performed,
number of axillary nodes removed, number of axillary nodes found positive, and tumor
size must be included on the CRFs. For patients who have more than one discrete tumor
masses should be measured and reported on the CRFs.)

- Patients must be within 3 months after the last cycle of chemotherapy.

- Patients must have the history of normal menstruation prior to the start of
chemotherapy.

- Stage I, II or III

- Woman, less than or equal to 45 years of age

- The test result of the estrogen receptor is positive.

- WHO performance status 0, 1 or 2.

- Patients who were treated with cytotoxic chemotherapy in pre or post surgery.
Permissible prior chemotherapy; currently locally available and approved standard
chemotherapy in the adjuvant or neoadjuvant setting: e.g.,
AC(Doxorubicin/cyclophosphamide) followed by taxane, AC(Doxorubicin/cyclophosphamide),
TA(Docetaxel/ Doxorubicin), FAC(5-fluorouracil/ doxorubicin / cyclophosphamide) or
others.

- Adequate hematological function defined by hemoglobin 10g/dl, neutrophil count 1.5 X
10 9/L and platelets 100 X 10 9/L.

- Adequate hepatic function defined by AST and ALT 2.5 X upper limit of normal. Alkaline
phosphatase 5 X upper limit of normal, unless bone metastases in the absence of liver
disease. Renal function adequate defined by creatinine < 175 mmol/L.

Exclusion Criteria:

- The test result of the estrogen receptor is negative or unknown.

- Patients with the history of hysterectomy or oophorectomy.

- Sarcomas or squamous cell carcinomas of the breast are not eligible.

- Patients with malignancies(other than breast cancer) within the last 5 years, except
for adequately treated in situ carcinoma of the cervix or basal cell/squamous cell
carcinoma of the skin.

- Investigational drugs given within the previous 4 weeks.

- Patients with thrombocytopenia (platelets < 100 X 10 9/L or on anti-coagulant
therapy(contra-indicated due to risk of bleeding with i.m. injection of Zoladex).

- Patients treated with CMF(cyclophosphamide/methotrexate/5-fluorouracil) as prior
chemotherapy.

- Patients who are pregnant or lactating are ineligible.