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

December 9, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Kayseri, Turkey
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Zoladex 3.6 mg Depot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: Each 3 months
Each 3 months
The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles
Time Frame: Each 3 months
Each 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (QOL) through-out the study measured by FACT-ES scale.
Time Frame: Each 3 months
Each 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8664L00012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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