Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

NCT00888082 | Withdrawn Phase 3

• 1 other identifier: D8664L00012
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

Brief Summary

Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements. The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.

Conditions

Breast Cancer; Ovarian Function

Keywords

adjuvant chemotherapy; breast cancer; goserelin acetate; ovarian function; Chemotherapy; Primary invasive breast cancer

Outcome Measures

Primary Outcomes (2)

• The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)

  Each 3 months

• The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles

  Each 3 months

Secondary Outcomes (1)

• Quality of life (QOL) through-out the study measured by FACT-ES scale.

  Each 3 months

Study Arms (2)

A

NO INTERVENTION

Patients receiving only adjuvant chemotherapy

B

EXPERIMENTAL

Patient receiving goserelin acetate along with adjuvant chemotherapy

Drug: Goserelin acetate

Interventions

Goserelin acetate DRUG

3.6 mg depot injectable preparation

Also known as: Zoladex 3.6 mg Depot

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pathologically confirmed invasive breast carcinoma
• Candidates for adjuvant chemotherapy for primary breast cancer
• Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels

You may not qualify if:

• Previous systemic chemotherapy
• Pregnancy
• Stage IV breast cancer

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Ankara, Turkey (Türkiye)

Location

Research Site

Istanbul, Turkey (Türkiye)

Location

Research Site

Kayseri, Turkey (Türkiye)

Location

Related Publications (11)

• Ataya K, Rao LV, Lawrence E, Kimmel R. Luteinizing hormone-releasing hormone agonist inhibits cyclophosphamide-induced ovarian follicular depletion in rhesus monkeys. Biol Reprod. 1995 Feb;52(2):365-72. doi: 10.1095/biolreprod52.2.365.

  PMID: 7711205 BACKGROUND

• Ataya KM, McKanna JA, Weintraub AM, Clark MR, LeMaire WJ. A luteinizing hormone-releasing hormone agonist for the prevention of chemotherapy-induced ovarian follicular loss in rats. Cancer Res. 1985 Aug;45(8):3651-6.

  PMID: 3926307 BACKGROUND

• Bines J, Oleske DM, Cobleigh MA. Ovarian function in premenopausal women treated with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1996 May;14(5):1718-29. doi: 10.1200/JCO.1996.14.5.1718.

  PMID: 8622093 BACKGROUND

• Blumenfeld Z, Eckman A. Preservation of fertility and ovarian function and minimization of chemotherapy-induced gonadotoxicity in young women by GnRH-a. J Natl Cancer Inst Monogr. 2005;(34):40-3. doi: 10.1093/jncimonographs/lgi015.

  PMID: 15784821 BACKGROUND

• Bokser L, Szende B, Schally AV. Protective effects of D-Trp6-luteinising hormone-releasing hormone microcapsules against cyclophosphamide-induced gonadotoxicity in female rats. Br J Cancer. 1990 Jun;61(6):861-5. doi: 10.1038/bjc.1990.192.

  PMID: 2142603 BACKGROUND

• Brincker H, Rose C, Rank F, Mouridsen HT, Jakobsen A, Dombernowsky P, Panduro J, Andersen KW. Evidence of a castration-mediated effect of adjuvant cytotoxic chemotherapy in premenopausal breast cancer. J Clin Oncol. 1987 Nov;5(11):1771-8. doi: 10.1200/JCO.1987.5.11.1771.

  PMID: 3316514 BACKGROUND

• Cheer SM, Plosker GL, Simpson D, Wagstaff AJ. Goserelin: a review of its use in the treatment of early breast cancer in premenopausal and perimenopausal women. Drugs. 2005;65(18):2639-55. doi: 10.2165/00003495-200565180-00011.

  PMID: 16392882 BACKGROUND

• Del Mastro L, Catzeddu T, Boni L, Bell C, Sertoli MR, Bighin C, Clavarezza M, Testa D, Venturini M. Prevention of chemotherapy-induced menopause by temporary ovarian suppression with goserelin in young, early breast cancer patients. Ann Oncol. 2006 Jan;17(1):74-8. doi: 10.1093/annonc/mdj029. Epub 2005 Oct 27.

  PMID: 16254024 BACKGROUND

• Del Mastro L, Venturini M, Sertoli MR et al. Phase III adjuvan trial comparing standard versus accelerated FEC regimen in early breast cancer patients. Results from GONO-MIG1 study. Breast Cancer Res Treat 2003; 82 (Suppl 1): S9 (Abstr).

  BACKGROUND

• Del Mastro L, Venturini M, Sertoli MR, Rosso R. Amenorrhea induced by adjuvant chemotherapy in early breast cancer patients: prognostic role and clinical implications. Breast Cancer Res Treat. 1997 Apr;43(2):183-90. doi: 10.1023/a:1005792830054.

  PMID: 9131274 BACKGROUND

• Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42.

  PMID: 9752815 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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

• Mustafa Özgüroğlu, Assoc.Prof.

  Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey

  STUDY CHAIR

• Yeşim Eralp, Assoc.Prof.

  Istanbul University Istanbul Medical Faculty, Oncology Institute, Medical Oncology Department, Capa 34360 Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

• Gül Başaran, Assoc.Prof.

  Marmara University Medical Faculty, Medical Oncology Department, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

• Kadri Altundağ, Prof.

  Hacettepe University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey

  PRINCIPAL INVESTIGATOR

• Filiz Çay Şenler, Assoc.Prof.

  Ankara University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey

  PRINCIPAL INVESTIGATOR

• Metin Özkan

  Erciyes University Medical Faculty, Medical Oncology Department, 38039 Kayseri, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

TU (3)