Back to resultsEvaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women (ASTRRA)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring premenopause, ovarian function suppression, tamoxifen
Eligibility Criteria
Inclusion Criteria:
- Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.
- 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
- Hormone receptor status : ER+ve and/or PgR+ve
- WHO performance status 0, 1 or 2.
- Patients who were treated with cytotoxic chemotherapy in pre- or post- surgery.
- Adequate haematological function defined by haemoglobin 10g/dL, neutrophil count 1.5x109/L and platelets 100x109/L.
- Adequate hepatic function defined by AST and ALT 2.5xupper limit of normal. Alkaline phosphatase 5xupper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine<175mmol/L.
Exclusion Criteria:
Patients whose primary breast cancer was classified as:
- ER(-),ER 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 known to be on any unlicensed non-cancer investigational agent.
- Patients with thrombocytopaenia (platelets <100 x 109/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.
Sites / Locations
- Department of Surgery, Korea Cancer Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
No Intervention
Active Comparator
Experimental
TAM+OFS(E) group
TAM(D) group
Permanent postmenopausal(A) group
TAM(B)
TAM+OFS (C)
Patients should be premenopausal women ,prior to the start of chemotherapy, less than or equal to 45 years of age with oestrogen receptor positive ± progesterone receptor positive who have undergone a primary mass excision, received an neo-/adjuvant chemotherapy ± radiotherapy for their stage I, II or III breast cancer. This arm is ovarian suppression group which have a various starting time of ovarian function suppression after neo-/adjuvant chemotherapy. Ovarian function suppression will be done by administration of LHRH agonist (ZOLADEXTM) for 2 years. After that, the patients will complete taking tamoxifen 20mg/day for 5 years.
Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 0, 6, 12, 18 and 24 months since the baseline asTsessment(0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized into the additional ovarian function suppression group or tamoxifen only group. The latter will complete taking tamoxifen 20mg/day for 5 years.
Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. Eligible patients except for premenopausal status at the baseline will be followed up until 2 years after the baseline assessment for evaluating the menopausal status. This group still remains to postmenopausal status and will taking tamoxifen 20mg/day for 5 years if they remain in the study.
Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 6, 12, 18 and 24 months since the baseline assessment (0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized into the additional ovarian function suppression group or tamoxifen only group. This group, patients are premenopausal women, they will be randomized into tamoxifen only group, complete taking tamoxifen 20mg/day for 5 years.
Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 6, 12, 18 and 24 months since the baseline assessment (0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized. This group, patients are premenopausal women, they will be randomized into the additional ovarian function suppression group. Ovarian function suppression will be done by administration of LHRH agonist (ZOLADEXTM) for 2 years. Then, Patients will complete taking tamoxifen 20mg/day for 5 years.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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