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

Primary Purpose

Breast Cancer, Ovarian Function

Status
Withdrawn
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Goserelin acetate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring adjuvant chemotherapy, breast cancer, goserelin acetate, ovarian function, Chemotherapy, Primary invasive breast cancer

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A

B

Arm Description

Patients receiving only adjuvant chemotherapy

Patient receiving goserelin acetate along with adjuvant chemotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2009
Last Updated
December 9, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00888082
Brief Title
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
Acronym
PROOF
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ovarian Function
Keywords
adjuvant chemotherapy, breast cancer, goserelin acetate, ovarian function, Chemotherapy, Primary invasive breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Description
Patients receiving only adjuvant chemotherapy
Arm Title
B
Arm Type
Experimental
Arm Description
Patient receiving goserelin acetate along with adjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
Goserelin acetate
Other Intervention Name(s)
Zoladex 3.6 mg Depot
Intervention Description
3.6 mg depot injectable preparation
Primary Outcome Measure Information:
Title
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)
Time Frame
Each 3 months
Title
The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles
Time Frame
Each 3 months
Secondary Outcome Measure Information:
Title
Quality of life (QOL) through-out the study measured by FACT-ES scale.
Time Frame
Each 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Özgüroğlu, Assoc.Prof.
Organizational Affiliation
Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yeşim Eralp, Assoc.Prof.
Organizational Affiliation
Istanbul University Istanbul Medical Faculty, Oncology Institute, Medical Oncology Department, Capa 34360 Istanbul, Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gül Başaran, Assoc.Prof.
Organizational Affiliation
Marmara University Medical Faculty, Medical Oncology Department, Istanbul, Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kadri Altundağ, Prof.
Organizational Affiliation
Hacettepe University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filiz Çay Şenler, Assoc.Prof.
Organizational Affiliation
Ankara University Medical Faculty, Medical Oncology Department, Sihhiye 06100 Ankara, Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Metin Özkan
Organizational Affiliation
Erciyes University Medical Faculty, Medical Oncology Department, 38039 Kayseri, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Kayseri
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
7711205
Citation
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.
Results Reference
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PubMed Identifier
3926307
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.
Results Reference
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PubMed Identifier
8622093
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. doi: 10.1200/JCO.1996.14.5.1718.
Results Reference
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PubMed Identifier
15784821
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. doi: 10.1093/jncimonographs/lgi015.
Results Reference
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PubMed Identifier
2142603
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. doi: 10.1038/bjc.1990.192.
Results Reference
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PubMed Identifier
3316514
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. doi: 10.1200/JCO.1987.5.11.1771.
Results Reference
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PubMed Identifier
16392882
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. doi: 10.2165/00003495-200565180-00011.
Results Reference
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PubMed Identifier
16254024
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. doi: 10.1093/annonc/mdj029. Epub 2005 Oct 27.
Results Reference
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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).
Results Reference
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PubMed Identifier
9131274
Citation
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.
Results Reference
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PubMed Identifier
9752815
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.
Results Reference
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Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

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