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

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ClinicalTrials.gov Identifier: NCT00068601
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : April 4, 2017
Last Update Posted : December 30, 2019
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Infertility
Menopausal Symptoms
Interventions Drug: cyclophosphamide
Drug: goserelin acetate
Enrollment 257
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Chemotherapy Chemotherapy Plus Goserelin
Hide Arm/Group Description

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

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

Period Title: Overall Study
Started 131 126
Completed 69 66
Not Completed 62 60
Reason Not Completed
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
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

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 of all reporting groups
Overall Number of Baseline Participants 113 105 218
Hide Baseline Analysis Population Description
Patients who are both eligible and evaluable
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 113 participants 105 participants 218 participants
38.7
(25.1 to 49.9)
37.6
(26.1 to 48.6)
37.7
(25.1 to 49.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 105 participants 218 participants
Female
113
 100.0%
105
 100.0%
218
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Rate of Premature Ovarian Failure at 2 Years
Hide Description Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study
Arm/Group Title Standard Chemotherapy Chemotherapy Plus Goserelin
Hide Arm/Group Description:

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

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

Overall Number of Participants Analyzed 69 66
Measure Type: Count of Participants
Unit of Measure: Participants
15
  21.7%
5
   7.6%
2.Secondary Outcome
Title Rate of Ovarian Dysfunction at 2 Years
Hide Description Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 2
Arm/Group Title Standard Chemotherapy Chemotherapy Plus Goserelin
Hide Arm/Group Description:

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

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

Overall Number of Participants Analyzed 67 63
Measure Type: Count of Participants
Unit of Measure: Participants
22
  32.8%
9
  14.3%
3.Secondary Outcome
Title Rate of Ovarian Dysfunction at 1 Year
Hide Description Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 1
Arm/Group Title Standard Chemotherapy Chemotherapy Plus Goserelin
Hide Arm/Group Description:

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

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

Overall Number of Participants Analyzed 75 78
Measure Type: Count of Participants
Unit of Measure: Participants
28
  37.3%
18
  23.1%
4.Other Pre-specified Outcome
Title Ovarian Reserve at 1 and 2 Years
Hide Description Measurements of ovarian reserve will consist of "Day 2 - 4" levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25).
Time Frame 1 and 2 years
Outcome Measure Data Not Reported
Time Frame Up to 5 years
Adverse Event Reporting Description This analysis includes all eligible patients who were evaluated for adverse events.
 
Arm/Group Title Standard Chemotherapy Chemotherapy Plus Goserelin
Hide Arm/Group Description Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen 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
All-Cause Mortality
Standard Chemotherapy Chemotherapy Plus Goserelin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Standard Chemotherapy Chemotherapy Plus Goserelin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/111 (0.00%)   1/103 (0.97%) 
Vascular disorders     
Thrombosis/thrombus/embolism  1  0/111 (0.00%)  1/103 (0.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Chemotherapy Chemotherapy Plus Goserelin
Affected / at Risk (%) Affected / at Risk (%)
Total   70/111 (63.06%)   73/103 (70.87%) 
Gastrointestinal disorders     
Nausea  1  9/111 (8.11%)  5/103 (4.85%) 
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  10/111 (9.01%)  8/103 (7.77%) 
Musculoskeletal and connective tissue disorders     
Osteoporosis  1  9/111 (8.11%)  1/103 (0.97%) 
Nervous system disorders     
Pain - Head/headache  1  36/111 (32.43%)  36/103 (34.95%) 
Psychiatric disorders     
Libido  1  27/111 (24.32%)  22/103 (21.36%) 
Mood alteration - agitation  1  26/111 (23.42%)  19/103 (18.45%) 
Mood alteration - anxiety  1  27/111 (24.32%)  31/103 (30.10%) 
Mood alteration - depression  1  36/111 (32.43%)  28/103 (27.18%) 
Reproductive system and breast disorders     
Irregular menses (change from baseline)  1  3/111 (2.70%)  12/103 (11.65%) 
Vaginal dryness  1  26/111 (23.42%)  30/103 (29.13%) 
Skin and subcutaneous tissue disorders     
Sweating (diaphoresis)  1  31/111 (27.93%)  34/103 (33.01%) 
Vascular disorders     
Hot flashes/flushes  1  48/111 (43.24%)  62/103 (60.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cancer Survivorship Committee Statistician
Organization: SWOG Statistics and Data Management Center
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00068601    
Obsolete Identifiers: NCT00696267
Other Study ID Numbers: CDR0000327758
S0230 ( Other Identifier: SWOG )
CALGB-40401 ( Other Identifier: CALGB )
IBCSG-34-05 ( Other Identifier: IBCSG )
U10CA037429 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: December 16, 2016
Results First Posted: April 4, 2017
Last Update Posted: December 30, 2019