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

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Sponsor:

Collaborators:

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Eastern Cooperative Oncology Group

ETOP IBCSG Partners Foundation

Information provided by (Responsible Party):

SWOG Cancer Research Network

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Standard Chemotherapy	Chemotherapy Plus Goserelin
Arm/Group Description	Patients receive cyclophosphamide-c...	Patients receive goserelin subcutan...
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

Baseline Characteristics

Arm/Group Title		Arm 1	Arm 2	Total
Arm/Group Description		Patients receive cyclophosphamide-c...	Patients receive goserelin subcutan...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Rate of Premature Ovarian Failure at 2 Years
Description	Ovarian failure at two years is defined as amenorrhea (absence of mens...
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

Outcome Measure Data

Analysis Population Description

Patients who completed the study


Arm/Group Title	Standard Chemotherapy	Chemotherapy Plus Goserelin
Arm/Group Description:	Patients receive cyclophosphamide-c...	Patients receive goserelin subcutan...
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
Description	Ovarian dysfunction is defined as amenorrhea for the preceding three m...
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

Outcome Measure Data

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
Arm/Group Description:	Patients receive cyclophosphamide-c...	Patients receive goserelin subcutan...
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
Description	Ovarian dysfunction is defined as amenorrhea for the preceding three m...
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

Outcome Measure Data

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
Arm/Group Description:	Patients receive cyclophosphamide-c...	Patients receive goserelin subcutan...
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
Description	Measurements of ovarian reserve will consist of "Day 2 - 4" ...
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

Adverse Events

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
Arm/Group Description	Patients receive cyclophosphamide-c...	Patients receive goserelin subcutan...
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	--/--	--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

More Information

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

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

Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS; POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015 Mar 5;372(10):923-32. doi: 10.1056/NEJMoa1413204.

Layout table for additonal information

Responsible Party:	SWOG Cancer Research Network
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

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