Ovarian Failure Clinical Trial
Official title:
Phase II Study of Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide Containing Chemotherapy: Menstruation Outcome
The use of adjuvant chemotherapy in younger women with early breast cancer (EBC) has
substantially improved the long-term outcome. However, this benefit is associated with
long-term toxic effects which are becoming more important as prognosis improves. These
include premature menopause and infertility in young pre-menopausal women. The incidence of
premature menopause depends on the type and intensity of chemotherapy and the patient's age.
In women <35 years old, the long-term (3 years after diagnosis) incidence of amenorrhea is
similar to women who have not received chemotherapy, at ∼ 10%, but this increases to 50% in
women between 35 and 40 years old, and can be up to 85% in women >40 years. Premature ovarian
failure has major consequences including sexual dysfunction and infertility, and the latter
may be of great concern to younger patients with breast cancer and has a bearing in
influencing treatment decisions in almost 30% of cases.
Currently, there is no standard treatment for preventing chemotherapy-induced ovarian
failure. Previous studies have suggested that temporary ovarian suppression with a
gonadotropin-releasing hormone (GnRH) analogue may preserve ovarian function both in humans
and animal models. Clinical data are conflicting. For example, a recent Italian multi-center
phase III study Prevention of Menopause-Induced by Chemotherapy: A Study in Early Breast
Cancer Patients-Gruppo Italiano Mamella 6 (PROMISE-GIM6) reported that the use of GnRH
analogue, triptorelin during chemotherapy in pre-menopausal patients with EBC, reduced the
occurrence of chemotherapy-induced early menopause with four pregnancies after a 26-month
follow-up [one in the chemotherapy alone arm and three in the triptorelin with chemotherapy
arm]. In contrast, another trial suggested that the use of goserelin concurrently with
neoadjuvant chemotherapy did not significantly reduce incidence of amenorrhea 6 months after
the end of chemotherapy compared with those receiving chemotherapy alone and only two
pregnancies were recorded [one in each arm] with a follow-up of 2 years.
In this phase II trial, patients will be randomly assigned, in a 1:1 ratio, to standard
adjuvant or neoadjuvant chemotherapy with the GnRH agonist goserelin (goserelin group) or to
chemotherapy without goserelin (chemotherapy alone group).
For Patients randomly assigned to the goserelin group, goserelin at a dose of 3.6 mg will be
administered subcutaneously every 4 weeks beginning 1 week before the initial chemotherapy
dose and will be continued to within 2 weeks before or after the final chemotherapy dose.
Follow up: All patients will be followed for at least 1 year clinically monthly and by
laboratory assessment by hormonal profile (FSH, LH, E2) every 6 months.
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