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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00912548
First received: May 31, 2009
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: goserelin
Drug: tamoxifen
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • all cause recurrence [ Time Frame: the first 5 years after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1234
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Nolvadex

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
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912548

Locations
Korea, Republic of
Department of Surgery, Korea Cancer Center Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Woo-Chul, Noh, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT00912548     History of Changes
Other Study ID Numbers: KBCSG005
Study First Received: May 31, 2009
Last Updated: June 15, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Breast Cancer Study Group:
premenopause
ovarian function suppression
tamoxifen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 16, 2013