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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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* 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

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

goserelin

Intervention Type DRUG

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.

tamoxifen

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

tamoxifen

Intervention Type DRUG

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

tamoxifen

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

goserelin

Intervention Type DRUG

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.

tamoxifen

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Zoladex® Nolvadex

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No