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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


Phase 3
18 Years
45 Years
Open (Enrolling by invite only)
Female
Breast Cancer

Thank you

Trial Information

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


- 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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

all cause recurrence

Outcome Time Frame:

the first 5 years after surgery

Safety Issue:

Yes

Principal Investigator

Woo-Chul Noh, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Korea Cancer Center Hospital, 215-4 Gongneung-dong, Nowon-gu, Seoul, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

KBCSG005

NCT ID:

NCT00912548

Start Date:

May 2009

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • premenopause
  • ovarian function suppression
  • tamoxifen
  • Breast Neoplasms

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