Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women

Conditions

Breast Cancer

Keywords

premenopause, ovarian function suppression, tamoxifen

Brief summary

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.

Detailed description

* 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

Jai Min Ryu, Soong June Bae, Woo Chul Noh, Hyun‐Ah Kim, Soo Yeon Baek et al. (20 authors)

Journal of Clinical Oncology2025-05-28

10.1200/jco.2025.43.16_suppl.506

Breast density reduction as a predictor for prognosis in premenopausal women with hormone receptor–positive breast cancer: A retrospective analysis of the ASTRRA study.

Soong June Bae, Hyun‐Ah Kim, Jai Min Ryu, Seho Park, Eun‐Gyeong Lee et al. (20 authors)

Journal of Clinical Oncology2022-06-01

10.1200/jco.2022.40.16_suppl.531

Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report.

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.

2021-05-1615 citations

10.1016/j.ejca.2021.03.017

Role of adding ovarian function suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or resume menstruation after chemotherapy: The ASTRRA study.

Woo Chul Noh, Jong Won Lee, Seok Jin Nam, Seho Park, Seock‐Ah Im et al. (21 authors)

Journal of Clinical Oncology2018-05-2018 citations

10.1200/jco.2018.36.15_suppl.502

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

Hyun‐Ah Kim, Sei Hyun Ahn, Seok Jin Nam, Seho Park, Jungsil Ro et al. (40 authors)

BMC Cancer2016-05-1922 citations

10.1186/s12885-016-2354-6

Interventions

DRUGgoserelin

1. Zoladex™ administration: Zoladex™ depot is available as a sterile disposable syringe. The depot is administered subcutaneously under the abdominal skin under sterile conditions. If necessary the injection site may be pre-treated with a local anaesthetic. 2. Sequence of administration Zoladex depot: The substance is administered for 24 months (2 years) at 28-day intervals (a period of 34 days between 2 administrations must not be exceeded). 3. Dosage: Each depot contains 3.6mg Zoladex. The substance Zoladex is contained in a while cylindrical rodlet . 4. Storage instructions for Zoladex™ Zoladex™ is kept a room temperature.

DRUGtamoxifen

1. Dose and period of Tamoxifen therapy: Tamoxifen is administered in tablet form. Each day 2 X 10 mg or 1 X 20 mg Tamoxifen are taken in the form of the respective tablet. 2. Storage instructions for Tamoxifen Tamoxifen is stored at room temperature away from light.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

No

Inclusion criteria

1. Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma. 2. Patients must be within 3 months after the last cycle of chemotherapy. 3. Patients must have the history of normal menstruation prior to the start of chemotherapy. 4. Stage I, II or III 5. Woman, less than or equal to 45 years of age 6. Hormone receptor status : ER+ve and/or PgR+ve 7. WHO performance status 0, 1 or 2. 8. Patients who were treated with cytotoxic chemotherapy in pre- or post- surgery. 9. Adequate haematological function defined by haemoglobin 10g/dL, neutrophil count 1.5x109/L and platelets 100x109/L. 10. 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

1. Patients whose primary breast cancer was classified as: * ER(-),ER unknown 2. Patients with the history of hysterectomy or oophorectomy 3. Sarcomas or squamous cell carcinomas of the breast are not eligible. 4. 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. 5. Investigational drugs given within the previous 4 weeks. 6. Patients known to be on any unlicensed non-cancer investigational agent. 7. 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). 8. Patients treated with CMF(cyclophosphamide/methotrexate/5-fluorouracil) as prior chemotherapy 9. Patients who are pregnant or lactating are ineligible.

Design outcomes

Primary

Measure	Time frame
all cause recurrence	the first 5 years after surgery

Countries

South Korea

Outcome results

None listed