Breast Neoplasms Clinical Trial
— ASTRRA-CYP2D6Official title:
Impact of CYP2D6 Genotype on the Clinical Effects of Tamoxifen Using With Samples From Prospective Randomized Multicenter Study
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).
Status | Recruiting |
Enrollment | 922 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Anam Hopital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Anam Hospital | Korean Breast Cancer Study Group, National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival(DFS) | 5years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03698942 -
Delphinus SoftVueâ„¢ ROC Reader Study
|
||
Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A |