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

June 15, 2009 updated by: Korean Breast Cancer Study Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

1234

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Surgery, Korea Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

  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.
Other Names:
  • Zoladex®
Drug: tamoxifen

  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.
Other Names:
  • 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.
Drug: tamoxifen

  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.
Other Names:
  • 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.
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.
Drug: tamoxifen

  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.
Other Names:
  • 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.
Drug: goserelin

  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.
Other Names:
  • Zoladex®
Drug: tamoxifen

  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.
Other Names:
  • Nolvadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause recurrence
Time Frame: the first 5 years after surgery
the first 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Breast Cancer Study Group

Investigators

  • Principal Investigator: Woo-Chul Noh, MD.PhD, Department of Surgery, Korea Cancer Center Hospital, 215-4 Gongneung-dong, Nowon-gu, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 31, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2009

Last Update Submitted That Met QC Criteria

June 15, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCSG005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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