Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women (ASTRRA)
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ClinicalTrials.gov Identifier: NCT00912548 |
Recruitment Status : Unknown
Verified June 2009 by Korean Breast Cancer Study Group.
Recruitment status was: Enrolling by invitation
First Posted : June 3, 2009
Last Update Posted : June 16, 2009
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: goserelin Drug: tamoxifen | Phase 3 |
- To compare overall Survival(OS) between the patients added Goserelin(ZOLADEXTM) to Tamoxifen and the patients treated with Tamoxifen alone in premenopausal status
- To compare 5-year disease free survival rate (DFS rate) between the patients who took tamoxifen only in postmenopause and the patients added Goserelin(ZOLADEXTM) to Tamoxifen for inducing ovarian function suppression in premenopause
- To determine the tolerability and safety of Tamoxifen with or without concomitant Zoladex
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1234 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomised Phase III Study for Evaluating the Role of the Addition of Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain in Premenopause or Regain Menstruation After Chemotherapy |
Study Start Date : | May 2009 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
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Experimental: TAM+OFS(E) group
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. |
Drug: goserelin
Other Name: Zoladex® Drug: tamoxifen
Other Name: Nolvadex |
Active Comparator: TAM(D) group
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.
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Drug: tamoxifen
Other Name: Nolvadex |
No Intervention: Permanent postmenopausal(A) group
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.
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Active Comparator: TAM(B)
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.
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Drug: tamoxifen
Other Name: Nolvadex |
Experimental: TAM+OFS (C)
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.
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Drug: goserelin
Other Name: Zoladex® Drug: tamoxifen
Other Name: Nolvadex |
- all cause recurrence [ Time Frame: the first 5 years after surgery ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912548
Korea, Republic of | |
Department of Surgery, Korea Cancer Center Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Woo-Chul Noh, MD.PhD | Department of Surgery, Korea Cancer Center Hospital, 215-4 Gongneung-dong, Nowon-gu, Seoul, Korea |
Responsible Party: | Woo-Chul, Noh, Korea Cancer Center Hospital |
ClinicalTrials.gov Identifier: | NCT00912548 |
Other Study ID Numbers: |
KBCSG005 |
First Posted: | June 3, 2009 Key Record Dates |
Last Update Posted: | June 16, 2009 |
Last Verified: | June 2009 |
premenopause ovarian function suppression tamoxifen |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Goserelin Estrogen Antagonists |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents |