Breast Cancer Clinical Trial
— PROOFOfficial title:
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study
Verified date | December 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of HealthTurkey: Ethics Committee |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 102 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Previous systemic chemotherapy - Pregnancy - Stage IV breast cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Research Site | Ankara | |
Turkey | Research Site | Istanbul | |
Turkey | Research Site | Kayseri |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Turkey,
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Epub 2005 Oct 27. — View Citation
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).
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. Review. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles | Each 3 months | No | |
Secondary | Quality of life (QOL) through-out the study measured by FACT-ES scale. | Each 3 months | No |
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