Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide

NCT03475758 | Unknown Phase 2

• 1 other identifier: GOP
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Failure

Outcome Measures

Primary Outcomes (1)

• compare rate of ovarian failure at 1 year between the two treatment groups

  rate of ovarian failure

  1 year

Study Arms (2)

chemotherapy without goserelin

NO INTERVENTION

these patients will receive their chemotherapy without addition of Goserelin

chemotherapy with goserelin

EXPERIMENTAL

these patients will receive their chemotherapy with addition of Goserelin

Drug: Goserelin

Interventions

Goserelin DRUG

adding goserelin with chemotherapy

Also known as: zoladex

chemotherapy with goserelin

Eligibility Criteria

• Gender Eligibility Details: premenopausal patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal cancer patients who will receive Cyclophosphamide-containing chemotherapy.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 22152853 BACKGROUND

MeSH Terms

Interventions

Goserelin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• samir Eid, phd

  Assiut University

  STUDY CHAIR

Central Study Contacts

ahmed abbas, MD

CONTACT

00201016114474; Ahmed_elhawary610@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 23, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share