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

History of Changes

Results First Received: December 16, 2016

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

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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

Description

Arm 1

Patients receive cyclophosphamide-containing chemotherapy alone.

cyclophosphamide: Part of planned chemotherapy regimen

Arm 2

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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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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

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	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):

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.

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 ( U.S. NIH Grant/Contract )
Study First Received:	September 10, 2003
Results First Received:	December 16, 2016
Last Updated:	February 15, 2017

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