| ID | Type | Description | Link |
|---|---|---|---|
| S0230 | Other Identifier | SWOG | |
| CALGB-40401 | Other Identifier | CALGB | |
| IBCSG-34-05 | Other Identifier | IBCSG | |
| U10CA037429 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Cancer and Leukemia Group B | NETWORK |
| Eastern Cooperative Oncology Group | NETWORK |
| ETOP IBCSG Partners Foundation |
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RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Chemotherapy | Active Comparator | Patients receive cyclophosphamide-containing chemotherapy alone. |
|
| Chemotherapy Plus Goserelin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | Part of planned chemotherapy regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Premature Ovarian Failure at 2 Years | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Ovarian Dysfunction at 2 Years | 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. | 2 years |
| Rate of Ovarian Dysfunction at 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian Reserve at 1 and 2 Years | 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). | 1 and 2 years |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative
Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Halle C Moore, MD | The Cleveland Clinic | Principal Investigator |
| Kathy S. Albain, MD | Loyola University | Study Chair |
| Silvana Martino, DO | Saint John's Cancer Institute | Study Chair |
| Ann H. Partridge, MD, MPH | Dana-Farber Cancer Institute | Study Chair |
| Lori J. Goldstein, MD | Fox Chase Cancer Center | Study Chair |
| Kelly-Anne Phillips | Peter MacCallum Cancer Centre, Australia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mater Hospital - North Sydney | North Sydney | New South Wales | 2060 | Australia | ||
| Royal North Shore Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25738668 | Derived | 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. |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Chemotherapy | Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen |
| FG001 | Chemotherapy Plus Goserelin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| NETWORK |
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| goserelin acetate | Drug | Given subcutaneously |
|
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. |
| 1 year |
| St Leonards |
| New South Wales |
| 2065 |
| Australia |
| Newcastle Mater Misericordiae Hospital | Waratah | New South Wales | 2298 | Australia |
| Royal Adelaide Hospital Cancer Centre | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Ballarat Oncology and Haematology Services | Ballarat | Victoria | 3350 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Medical Center - Clayton Campus | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre | East Melbourne | Victoria | 3002 | Australia |
| Maroondah Hospital | East Ringwood | Victoria | 3135 | Australia |
| St. Vincent's Hospital - Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Centre Hospitalier Hutois | Huy | 4500 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Centre Hospitalier Regional de la Citadelle | Liège | 4000 | Belgium |
| CHU Liege - Domaine Universitaire du Sart Tilman | Liège | B-4000 | Belgium |
| AZ Damiaan | Ostend | 8400 | Belgium |
| Centre Hospitalier Peltzer-La Tourelle | Verviers | B-4800 | Belgium |
| National Institute of Oncology | Budapest | 1122 | Hungary |
| Ospedali Riuniti di Bergamo | Bergamo | 24100 | Italy |
| Ospedale degli Infermi - ASL 12 | Biella | 13900 | Italy |
| Ospedale Civile Ramazzini | Carpi | 41012 | Italy |
| Ospedale Alessandro Manzoni | Lecco | 23900 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| Auckland City Hospital | Auckland | 1 | New Zealand |
| Oncology Institute of Southern Switzerland | Bellinzona | CH-6500 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| Oncology Institute of Southern Switzerland - Locarno | Locarno | CH-6601 | Switzerland |
| Oncology Institute of Southern Switzerland - Lugano | Lugano | CH-6900 | Switzerland |
| Oncology Institute of Southern Switzerland - Mendrisio | Mendrisio | CH-6850 | Switzerland |
| Regionalspital | Thun | 3600 | Switzerland |
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
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients who are both eligible and evaluable
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Premature Ovarian Failure at 2 Years | 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. | Patients who completed the study | Posted | Count of Participants | Participants | 2 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Rate of Ovarian Dysfunction at 2 Years | 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. | Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 2 | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Ovarian Reserve at 1 and 2 Years | 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). | Not Posted | 1 and 2 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Rate of Ovarian Dysfunction at 1 Year | 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. | Patients with both menstrual status data and at least two available laboratory values (FSH, inhibin B, or estradiol levels) at year 1 | Posted | Count of Participants | Participants | 1 year |
|
|
Up to 5 years
This analysis includes all eligible patients who were evaluated for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Chemotherapy | Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen | 0 | 111 | 70 | 111 | ||
| EG001 | 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 | 1 | 103 | 73 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Libido | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes/flushes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cancer Survivorship Committee Statistician | SWOG Statistics and Data Management Center | 206-667-4623 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| Male |
|
|
|