Trial for Young Women Studies Effectiveness of Goserelin to Prevent Early Menopause

By Anna Shaffer, LBBC Staff

This national clinical trial will compare the effectiveness of goserelin combined with chemotherapy to chemotherapy alone in preventing ovarian failure in young women with breast cancer

Sponsored By: National Cancer Institute

A national clinical trial will compare the effectiveness of ovarian suppression combined with chemotherapy versus chemotherapy alone in preventing early menopause in young women with breast cancer.

This randomized phase III trial will compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy and goserelin (brand name: Zoladex) to those treated with chemotherapy alone. Because goserelin blocks hormone production in the ovaries, researchers hope ovarian suppression using goserelin will effectively protect the ovaries from being damaged by the toxic effects of chemotherapy and preserve fertility in young women receiving chemotherapy for breast cancer.

Participants will be divided according to age (under 40 versus 40 to 49) and planned chemotherapy regimen. They will then be randomly assigned to one of two groups.

Those in the first group will receive goserelin once every four weeks one week before starting chemotherapy. Unless the disease progresses or the side effects become too severe, treatment will continue until chemotherapy is complete. Those in the second group will receive chemotherapy alone. Researchers will evaluate participants after one, two and five years.

This trial is recruiting participants nationwide. To participate, you must be a premenopausal woman age 18 to 49 with stage I-IIIA, hormone receptor-negative breast cancer. You must be planning to receive three to eight months of a preoperative or adjuvant chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting one of the following criteria: a three-month/four-course anthracycline-based regimen, a six- to eight-month/course anthracycline-based regimen, or a six- to eight-month/course non-anthracycline-based regimen. You may not participate if you are pregnant or nursing or if you had prior chemotherapy. If you are fertile you must use effective barrier contraception. You may not undergo other concurrent hormonal therapy during this trial. If you had a prior cancer, you may only participate if you had adequately treated basal cell or squamous cell skin cancer, or if you had in situ cancer from which you have been disease-free for at least five years after treatment.

If you are a young woman who will undergo chemotherapy for hormone receptor-negative breast cancer, you may want to consider participating in this study. Your tumor must be removable by surgery. This study of 416 people will be conducted over five years.

Read more about this clinical trial.

For more information, contact: 800.4.CANCER

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