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NCT00427245

Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer

Last Updated: 2013-08-07

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.

Detailed Description

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OBJECTIVES:

Primary

* Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .

Secondary

* Compare the quality of life of patients treated with these regimens.
* Compare menopausal symptoms in patients treated with these regimens.
* Compare bone mineral density loss in patients treated with these regimens.
* Compare hormone levels in patients treated with these regimens.
* Compare menstruation in patients treated with these regimens.
* Compare the incidence of pregnancy in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study. Patients are stratified according to age (≤ 40 years vs \> 40 years) and participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide- and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy. Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.

Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually for up to 5 years.

After completion of study therapy, patients are followed periodically for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Conditions

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Breast Cancer Infertility Menopausal Symptoms

Keywords

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menopausal symptoms infertility stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer estrogen receptor-negative breast cancer estrogen receptor-positive breast cancer progesterone receptor-negative breast cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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cyclophosphamide

Intervention Type DRUG

goserelin acetate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

fertility assessment and management

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast cancer

* Stages I-IIIB with node-positive or -negative disease (N0-2)
* Operable disease
* Must meet 1 of the following criteria:

* Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
* Scheduled to receive neoadjuvant chemotherapy
* No metastatic breast cancer, including supraclavicular fossa metastases
* Hormone receptor status meeting 1 of the following criteria:

* Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy
* ER positive AND no requirement for ovarian suppression as a necessary part of treatment

PATIENT CHARACTERISTICS:

* Female
* Premenopausal with regular menses in the 12 months preceding surgery
* No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Suitable fitness status for chemotherapy
* Adequate hepatic, renal, and bone marrow function
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy or endocrine therapy

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Principal Investigators

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Robert C.F. Leonard, MD, BS, MB

Role: STUDY_CHAIR

Charing Cross Hospital

Locations

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Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, United Kingdom

Site Status

Royal United Hospital

Bath, England, United Kingdom

Site Status

Frenchay Hospital

Bristol, England, United Kingdom

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Addenbrooke's Hospital

Cambridge, England, United Kingdom

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Halton Hospital

Cheshire, England, United Kingdom

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Essex County Hospital

Colchester, England, United Kingdom

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Dorset County Hospital

Dorchester, England, United Kingdom

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Russells Hall Hospital

Dudley, England, United Kingdom

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Queen Elizabeth Hospital

Gateshead, England, United Kingdom

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Diana Princess of Wales Hospital

Grimsby, England, United Kingdom

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UCL Cancer Institute

Hampstead, London, England, United Kingdom

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Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

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King George Hospital

Ilford, Essex, England, United Kingdom

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Ipswich Hospital

Ipswich, England, United Kingdom

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Kidderminster Hospital

Kidderminster Worcestershire, England, United Kingdom

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Yorkshire Regional Clinical Trials & Research Unit

Leeds, England, United Kingdom

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