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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00888082
First received: April 23, 2009
Last updated: December 9, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Ovarian Function
 Drug: Goserelin acetate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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) [ Time Frame: Each 3 months ] [ Designated as safety issue: No ]
  • The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles [ Time Frame: Each 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (QOL) through-out the study measured by FACT-ES scale. [ Time Frame: Each 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Patients receiving only adjuvant chemotherapy
Experimental: B
Patient receiving goserelin acetate along with adjuvant chemotherapy
 Drug: Goserelin acetate
3.6 mg depot injectable preparation
Other Name: Zoladex 3.6 mg Depot

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888082

Locations
Turkey
Research Site
Ankara, Turkey
Research Site
Istanbul, Turkey
Research Site
Kayseri, Turkey
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Mustafa Özgüroğlu, Assoc.Prof. Istanbul University Cerrahpasa Medical Faculty, Medical Oncology Clinic, Cerrahpasa 34098, Istanbul, Turkey
Principal Investigator: 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
  More Information

Publications:
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).

Responsible Party: MC MD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00888082     History of Changes
Other Study ID Numbers: D8664L00012
Study First Received: April 23, 2009
Last Updated: December 9, 2010
Health Authority: Turkey: Ministry of Health
Turkey: Ethics Committee

Keywords provided by AstraZeneca:
adjuvant chemotherapy
breast cancer
goserelin acetate
 ovarian function
Chemotherapy
Primary invasive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Goserelin
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013