Know Cancer

or
forgot password

A Clinical Study for the Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen in Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastatic Disease

Thank you

Trial Information

A Clinical Study for the Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen in Patients With Metastatic Breast Cancer


Inclusion Criteria:



- Histologically or cytologically diagnosed stage IV or recurrent breast cancer
patients according to American Joint Committee on Cancer (AJCC)

- Positive estrogen receptor or Positive progesterone receptor.

- Females at least 18 years of age.

- Prior radiation therapy is allowed as long as the irradiated area is not the only
source of measurable disease

- Prior hormone therapy less than 2.

- No history of Megace medication for recent 28 days

- Performance status of 0, 1 and 2 on the ECOG criteria

- Clinically measurable disease, defined as bidimensionally measurable lesions with
clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions
serving as measurable disease must be at east 1 cm by 1 cm, as defined by x-ray, CT
scan, MRI, or physical examination

- Bone only or pleural fluid only disease is included as long as evaluation for
clinical benefit is possible

- Estimated life expectancy of at least 12 weeks

- Compliant patient who can be followed-up adequately.

- Adequate hematologic (WBC count 3,000/mm3, platelet count 100,000/mm3), hepatic
(bilirubin level 1.8 mg/dL, AST, ALT 1.5xULN, albumin 2.5 g/dL), and renal
(creatinine concentration 1.5 mg/dL) function.

- Informed consent from patient or patient's relative

- Childbearing women should use non-hormonal contraceptive method

Exclusion Criteria:

- Active or uncontrolled infection.

- Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin or prior malignancy treated more than 5
years ago without recurrence).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy of tamoxifen

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Jungsil Ro, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Institutional Review Board

Study ID:

NCCCTS-06-198

NCT ID:

NCT00532454

Start Date:

June 2006

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Metastatic Disease
  • Breast Neoplasms
  • Neoplasm Metastasis

Name

Location