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

Breast Cancer Clinical Trial

— ASTRRA  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00912548
• Other study ID #: KBCSG005
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: May 31, 2009
• Last updated: June 15, 2009
• Start date: May 2009
• Est. completion date: December 2015

Study information

• Verified date: June 2009
• Source: Korean Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1234
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• goserelin
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. 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). Dosage: Each depot contains 3.6mg Zoladex. The substance Zoladex is contained in a while cylindrical rodlet . Storage instructions for Zoladex™ Zoladex™ is kept a room temperature.
• tamoxifen
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. Storage instructions for Tamoxifen Tamoxifen is stored at room temperature away from light.

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Korea Cancer Center Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause recurrence		the first 5 years after surgery	Yes