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S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
International Breast Cancer Study Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00068601
First received: September 10, 2003
Last updated: February 15, 2017
Last verified: February 2017
Results First Received: December 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Infertility
Menopausal Symptoms
Interventions: Drug: cyclophosphamide
Drug: goserelin acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Chemotherapy

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

Chemotherapy Plus Goserelin

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.

cyclophosphamide: Part of planned chemotherapy regimen

goserelin acetate: Given subcutaneously


Participant Flow:   Overall Study
    Standard Chemotherapy   Chemotherapy Plus Goserelin
STARTED   131   126 
COMPLETED   69   66 
NOT COMPLETED   62   60 
Ineligible                11                13 
Not evaluable: withdrew consent                5                4 
Not evaluable: hysterectomy/oophorectomy                2                4 
Death                11                3 
Lost to Follow-up                3                2 
Missing primary outcome data                30                34 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who are both eligible and evaluable

Reporting Groups
  Description
Arm 1

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

Arm 2

Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.

cyclophosphamide: Part of planned chemotherapy regimen

goserelin acetate: Given subcutaneously

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 113   105   218 
Age 
[Units: Years]
Median (Full Range)
 38.7 
 (25.1 to 49.9) 
 37.6 
 (26.1 to 48.6) 
 37.7 
 (25.1 to 49.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      113 100.0%      105 100.0%      218 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Premature Ovarian Failure at 2 Years   [ Time Frame: 2 years ]

2.  Secondary:   Rate of Ovarian Dysfunction at 2 Years   [ Time Frame: 2 years ]

3.  Secondary:   Rate of Ovarian Dysfunction at 1 Year   [ Time Frame: 1 year ]

4.  Other Pre-specified:   Ovarian Reserve at 1 and 2 Years   [ Time Frame: 1 and 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cancer Survivorship Committee Statistician
Organization: SWOG Statistics and Data Management Center
phone: 206-667-4623


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00068601     History of Changes
Obsolete Identifiers: NCT00696267
Other Study ID Numbers: CDR0000327758
S0230 ( Other Identifier: SWOG )
CALGB-40401 ( Other Identifier: CALGB )
IBCSG-34-05 ( Other Identifier: IBCSG )
U10CA037429 ( US NIH Grant/Contract Award Number )
Study First Received: September 10, 2003
Results First Received: December 16, 2016
Last Updated: February 15, 2017