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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | Patients receiving only adjuvant chemotherapy | |
| B | Experimental | Patient receiving goserelin acetate along with adjuvant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin acetate | Drug | 3.6 mg depot injectable preparation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QOL) through-out the study measured by FACT-ES scale. | Each 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ankara | Turkey (Türkiye) | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7711205 | Background | 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. | |
| 3926307 | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Istanbul |
| Turkey (Türkiye) |
| Research Site | Kayseri | Turkey (Türkiye) |
| 8622093 | 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. |
| 15784821 | 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. |
| 2142603 | 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. |
| 3316514 | 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. |
| 16392882 | 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. |
| 16254024 | 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. |
| 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). |
| 9131274 | 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. |
| 9752815 | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |