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The purpose of this study is to compare 5-year disease free survival rate (DFS rate) between the hormone receptor positive breast cancer patients who were added Goserelin to Tamoxifen for ovarian function suppression after neo-/adjuvant cytotoxic chemotherapy and the hormone receptor positive breast cancer patients who were treated with Tamoxifen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAM+OFS(E) group | Experimental | 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. |
|
| TAM(D) group | Active Comparator | 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. |
|
| Permanent postmenopausal(A) group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| goserelin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| all cause recurrence | the first 5 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Patients whose primary breast cancer was classified as:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Woo-Chul Noh, MD.PhD | Department of Surgery, Korea Cancer Center Hospital, 215-4 Gongneung-dong, Nowon-gu, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Korea Cancer Center Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34010788 | Derived | Kim HJ, Noh WC, Nam SJ, Park BW, Lee ES, Im SA, Jung YS, Yoon JH, Kang SS, Park KH, Lee SJ, Jeong J, Lee MH, Cho SH, Kim SY, Kim HA, Han SH, Han W, Hur MH, Kim S, Ahn SH. Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report. Eur J Cancer. 2021 Jul;151:190-200. doi: 10.1016/j.ejca.2021.03.017. Epub 2021 May 16. | |
| 31518174 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| TAM(B) | Active Comparator | 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. |
|
| TAM+OFS (C) | Experimental | 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. |
|
|
|
| tamoxifen | Drug |
|
|
|
| Derived |
| Kim HA, Lee JW, Nam SJ, Park BW, Im SA, Lee ES, Jung YS, Yoon JH, Kang SS, Lee SJ, Park KH, Jeong J, Cho SH, Kim SY, Kim LS, Moon BI, Lee MH, Kim TH, Park C, Jung SH, Gwak G, Kim J, Kang SH, Jin YW, Kim HJ, Han SH, Han W, Hur MH, Noh WC; Korean Breast Cancer Study Group. Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial. J Clin Oncol. 2020 Feb 10;38(5):434-443. doi: 10.1200/JCO.19.00126. Epub 2019 Sep 16. |
| 27197523 | Derived | Kim HA, Ahn SH, Nam SJ, Park S, Ro J, Im SA, Jung YS, Yoon JH, Hur MH, Choi YJ, Lee SJ, Jeong J, Cho SH, Kim SY, Lee MH, Kim LS, Moon BI, Kim TH, Park C, Kim SJ, Jung SH, Park H, Gwak GH, Kang SH, Kim JG, Kim J, Choi SY, Lim CW, Kim D, Yoo Y, Song YJ, Kang YJ, Jung SS, Shin HJ, Lee KJ, Han SH, Lee ES, Han W, Kim HJ, Noh WC. The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA): study protocol for a randomized controlled trial and progress. BMC Cancer. 2016 May 19;16:319. doi: 10.1186/s12885-016-2354-6. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |