Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide

NCT ID: NCT03475758

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2020-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Ovarian Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

chemotherapy without goserelin

these patients will receive their chemotherapy without addition of Goserelin

Group Type: NO_INTERVENTION

No interventions assigned to this group

chemotherapy with goserelin

these patients will receive their chemotherapy with addition of Goserelin

Group Type: EXPERIMENTAL

Goserelin

Intervention Type: DRUG

adding goserelin with chemotherapy

Interventions

Goserelin

adding goserelin with chemotherapy

Intervention Type: DRUG

Other Intervention Names

zoladex

Eligibility Criteria

Inclusion Criteria

Premenopausal cancer patients who will receive Cyclophosphamide-containing chemotherapy.

Exclusion Criteria

postmenopausal cancer patients. cancer patients who will receive non Cyclophosphamide containing chemotherapy.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Ashraf Saadeldin

assisstant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

samir Eid, phd

Role: STUDY_CHAIR

Assiut University

Central Contacts

ahmed abbas, MD

Role: CONTACT

Ahmed_elhawary610@yahoo.com

00201016114474

References

Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.

Reference Type: BACKGROUND

PMID: 22152853 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

GOP

Identifier Type: -

Identifier Source: org_study_id