Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
Purpose
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- A patient cannot be considered eligible for this study unless ALL of the following conditions are met. - The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information. - Female patients must be greater than or equal to 18 years of age. - Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as: - Age 50 years or under with spontaneous menses within 12 months; or - Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or - Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or - Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range. - The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%). - Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. - Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. - Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy. - For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.) - For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.) - Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND). - The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: - By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.) - By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c). - Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes. - Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1. - Oncotype DX RS (recurrence score) requirements*: - If node-negative: - Oncotype DX RS must be RS 21-25, or - Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm. - If 1-3 nodes involved: - Oncotype DX RS must be less than 26. * Patients with a "Low Risk" or "MP1" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible. - The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive. - The tumor must be HER2-negative by current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines based on local testing results. - The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks. - Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received. - Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent. - HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. - Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.
Exclusion Criteria
- • Definitive clinical or radiologic evidence of metastatic disease. - pT4 (pathological state) tumors, including inflammatory breast cancer. - History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and/or previous DCIS or LCIS are eligible.) - If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer. - Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator. Known results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values: - ANC (absolute neutrophil count) less than 1200/mm3; - Platelet count less than 100,000/mm3; - Hemoglobin less than 10 g/dL; - Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; - AST(aspartate aminotransferase)(SGOT)/ALT (alanine transminase)(SGPT): greater than 3 × institutional ULN; - Renal function of GFR (glomular filtration rate) less than 30 mL/min/1.73m2. - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. - Non-epithelial breast malignancies such as sarcoma or lymphoma. - Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed. - Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin/progesterone IUDs). - Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy. - Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.) - Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Arm 1: Ovarian Function Suppression + Aromatase Inhibitor |
Aromatase inhibitor co-administered with a GnRH agonist (gonadotropin releasing hormone) for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired. |
|
Active Comparator Arm 2 Adjuvant Chemotherapy + Ovarian Function Suppression + Aromatase Inhibitor |
Adjuvant chemotherapy of investigator's choice followed by an aromatase inhibitor (AI) co-administered with an GnRH agonist for 5 years. The choice of AI is per investigator discretion. The choice of GnRH agonist and dosing schedule is per investigator's discretion. Options commonly include goserelin, leuprolide, or triptorelin given monthly or every-three-months. The dose and schedule of AI should be consistent with the drug package insert. Endocrine treatment beyond 5 years is at the investigator's discretion. Bilateral oophorectomy may substitute for ovarian suppression if desired. |
|
Recruiting Locations
Anchorage 5879400, Alaska 5879092 98508
Anchorage 5879400, Alaska 5879092 99508
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Grayslake 4894465, Illinois 4896861 60030
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312-695-1102
Harvey 4895298, Illinois 4896861 60426
Hazel Crest 4895416, Illinois 4896861 60429
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708-799-9995
Highland Park 4895876, Illinois 4896861 60035
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847-570-2109
Homer Glen 4896336, Illinois 4896861 60491
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708-216-9000
Kewanee 4898433, Illinois 4896861 61443
Lake Forest 4899012, Illinois 4896861 60045
Libertyville 4899739, Illinois 4896861 60048
Libertyville 4899739, Illinois 4896861 60048
Macomb 4900817, Illinois 4896861 61455
Mattoon 4244099, Illinois 4896861 61938
Maywood 4901514, Illinois 4896861 60153
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708-226-4357
Melrose Park 4901868, Illinois 4896861 60160
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708-450-4554
Moline 4902476, Illinois 4896861 61265
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309-779-2000
Mount Vernon 4245152, Illinois 4896861 62864
Naperville 4903279, Illinois 4896861 60540
Site Public Contact
630-646-6075
New Lenox 4903535, Illinois 4896861 60451
Normal 4903780, Illinois 4896861 61761
Normal 4903780, Illinois 4896861 61761
O'Fallon 4245926, Illinois 4896861 62269
O'Fallon 4245926, Illinois 4896861 62269
Oak Lawn 4904365, Illinois 4896861 60453-2699
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800-323-8622
Oak Lawn 4904365, Illinois 4896861 60453
Orland Park 4904937, Illinois 4896861 60462
Orland Park 4904937, Illinois 4896861 60462
Ottawa 4905006, Illinois 4896861 61350
Palos Heights 4905259, Illinois 4896861 60463
Park Ridge 4905367, Illinois 4896861 60068
Site Public Contact
847-384-3621
Pekin 4905599, Illinois 4896861 61554
Pekin 4905599, Illinois 4896861 61554
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61636
Peoria 4905687, Illinois 4896861 61637
Peru 4905770, Illinois 4896861 61354
Peru 4905770, Illinois 4896861 61354
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815-664-4141
Plainfield 4906125, Illinois 4896861 60585
Princeton 4906818, Illinois 4896861 61356
Rockford 4907959, Illinois 4896861 61114
Shiloh 4249910, Illinois 4896861 62269
Skokie 4911600, Illinois 4896861 60076
Springfield 4250542, Illinois 4896861 62702
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217-545-7929
Springfield 4250542, Illinois 4896861 62702
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800-444-7541
Springfield 4250542, Illinois 4896861 62781
Urbana 4914570, Illinois 4896861 61801
Warrenville 4915525, Illinois 4896861 60555
Washington 4915545, Illinois 4896861 61571
Yorkville 4917298, Illinois 4896861 60560
Avon 4254021, Indiana 4921868 46123
Carmel 4255466, Indiana 4921868 46032
Crown Point 4919451, Indiana 4921868 46307
Fort Wayne 4920423, Indiana 4921868 46845
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877-784-4673
Goshen 4920808, Indiana 4921868 46526
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46237
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317-528-7060
Mooresville 4261585, Indiana 4921868 46158
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317-834-3603
Munster 4924014, Indiana 4921868 46321
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219-922-7469
New Albany 4262045, Indiana 4921868 47150
Richmond 4263681, Indiana 4921868 47374
Ames 4846834, Iowa 4862182 50010
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515-956-4132
Ames 4846834, Iowa 4862182 50010
Ankeny 4846960, Iowa 4862182 50023
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515-241-3305
Bettendorf 4848489, Iowa 4862182 52722
Boone 4849051, Iowa 4862182 50036
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515-956-4132
Cedar Rapids 4850751, Iowa 4862182 52403
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319-365-4673
Cedar Rapids 4850751, Iowa 4862182 52403
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319-363-2690
Clive 4852065, Iowa 4862182 50325
Clive 4852065, Iowa 4862182 50325
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515-241-3305
Creston 4853078, Iowa 4862182 50801
Des Moines 4853828, Iowa 4862182 50309
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515-241-3305
Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
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515-241-3305
Fort Dodge 4857486, Iowa 4862182 50501
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515-956-4132
Fort Dodge 4857486, Iowa 4862182 50501
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515-574-8302
Iowa City 4862034, Iowa 4862182 52242
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800-237-1225
Jefferson 4862482, Iowa 4862182 50129
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515-956-4132
Marshalltown 4866371, Iowa 4862182 50158
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515-956-4132
Waukee 4880981, Iowa 4862182 50263
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515-241-3305
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
Site Public Contact
515-875-9815
Garden City 5445439, Kansas 4273857 67846
Great Bend 4272340, Kansas 4273857 67530
Hays 4272782, Kansas 4273857 67601
Site Public Contact
785-623-5774
Kansas City 4273837, Kansas 4273857 66160
Lawrence 4274277, Kansas 4273857 66044
Olathe 4276614, Kansas 4273857 66061
Overland Park 4276873, Kansas 4273857 66210
Overland Park 4276873, Kansas 4273857 66211
Pittsburg 4277241, Kansas 4273857 66762
Salina 4278890, Kansas 4273857 67401
Topeka 4280539, Kansas 4273857 66606
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785-295-8000
Westwood 4281639, Kansas 4273857 66205
Ashland 4282757, Kentucky 6254925 41101
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606-327-6499
Bardstown 4283133, Kentucky 6254925 40004
Corbin 4288656, Kentucky 6254925 40701
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859-523-1934
Corbin 4288656, Kentucky 6254925 40701
Elizabethtown 4290988, Kentucky 6254925 42701
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270-706-5470
Lexington 4297983, Kentucky 6254925 40503
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859-260-6425
Lexington 4297983, Kentucky 6254925 40504
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Lexington 4297983, Kentucky 6254925 40509
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866-213-3025
Lexington 4297983, Kentucky 6254925 40509
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859-257-3379
London 4298960, Kentucky 6254925 40741
Louisville 4299276, Kentucky 6254925 40202
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502-562-3429
Louisville 4299276, Kentucky 6254925 40207
Louisville 4299276, Kentucky 6254925 40245
Mount Sterling 4301683, Kentucky 6254925 40353
Paducah 4048662, Kentucky 6254925 42003
Site Public Contact
270-575-2928
Baton Rouge 4315588, Louisiana 4331987 70809
Covington 4321005, Louisiana 4331987 70433
New Orleans 4335045, Louisiana 4331987 70112
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New Orleans 4335045, Louisiana 4331987 70121
Shreveport 4341513, Louisiana 4331987 71105
Kennebunk 4968729, Maine 4971068 04043
Topsham 4980927, Maine 4971068 04086
Westbrook 4982753, Maine 4971068 04092
Site Public Contact
207-303-3300
Baltimore 4347778, Maryland 4361885 21201
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800-888-8823
Baltimore 4347778, Maryland 4361885 21202
Baltimore 4347778, Maryland 4361885 21204
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443-849-3706
Baltimore 4347778, Maryland 4361885 21215
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410-601-9083
Baltimore 4347778, Maryland 4361885 21237
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443-777-7364
Baltimore 4347778, Maryland 4361885 21239
Baltimore 4347778, Maryland 4361885 21244
Baltimore 4347778, Maryland 4361885 21287
Elkton 4354234, Maryland 4361885 21921
Frederick 4355585, Maryland 4361885 21702
Site Public Contact
301-668-7043
Gaithersburg 4355843, Maryland 4361885 20879
Glen Burnie 4356188, Maryland 4361885 21061
Site Public Contact
410-553-8100
Kensington 4359760, Maryland 4361885 20895
Largo 4360345, Maryland 4361885 20774
Lutherville 4361379, Maryland 4361885 21093
Olney 4364537, Maryland 4361885 20832
Site Public Contact
855-546-1944
Randallstown 4366476, Maryland 4361885 21133
Beverly 4930505, Massachusetts 6254926 01915
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978-922-3000
Boston 4930956, Massachusetts 6254926 02111
Boston 4930956, Massachusetts 6254926 02215
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617-667-9925
Boston 4930956, Massachusetts 6254926 02215
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877-442-3324
Burlington 4931737, Massachusetts 6254926 01805
Gloucester 4937829, Massachusetts 6254926 01930
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978-283-4000
Lowell 4942618, Massachusetts 6254926 01854
Newburyport 4945256, Massachusetts 6254926 01950
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978-463-1374
Peabody 4946863, Massachusetts 6254926 01960
Springfield 4951788, Massachusetts 6254926 01199
Alma 4984049, Michigan 5001836 48801
Alpena 4984075, Michigan 5001836 49707
Ann Arbor 4984247, Michigan 5001836 48106
Ann Arbor 4984247, Michigan 5001836 48109
Battle Creek 4985153, Michigan 5001836 49017
Bay City 4985180, Michigan 5001836 48706
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48116
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800-865-1125
Brownstown, Michigan 5001836 48183
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Clarkston 4988997, Michigan 5001836 48346
Clarkston 4988997, Michigan 5001836 48346
Clarkston 4988997, Michigan 5001836 48346
Clinton Township 4989133, Michigan 5001836 48038
Dearborn 4990510, Michigan 5001836 48124
Site Public Contact
248-551-7695
Detroit 4990729, Michigan 5001836 48201
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48236
East China Township, Michigan 5001836 48054
Escanaba 4992232, Michigan 5001836 49829
Farmington Hills 4992523, Michigan 5001836 48334
Farmington Hills 4992523, Michigan 5001836 48336
Site Public Contact
248-551-7695
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48532
Gladwin 4993985, Michigan 5001836 48624
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Jackson 4997384, Michigan 5001836 49201
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49009
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574-647-7370
Kalamazoo 4997787, Michigan 5001836 49048
Site Public Contact
574-647-7370
Lansing 4998830, Michigan 5001836 48910
Lansing 4998830, Michigan 5001836 48912
Lapeer 4998842, Michigan 5001836 48446
Livonia 4999837, Michigan 5001836 48154
Macomb 5000473, Michigan 5001836 48044
Macomb 5000473, Michigan 5001836 48044
Marquette 5000947, Michigan 5001836 49855
Marquette 5000947, Michigan 5001836 49855
Midland 5001929, Michigan 5001836 48670
Mount Clemens 5002656, Michigan 5001836 48043
Mount Pleasant 5002714, Michigan 5001836 48858
Muskegon 5003132, Michigan 5001836 49444
Niles 5003514, Michigan 5001836 49120
Site Public Contact
616-391-1230
Norton Shores 5004005, Michigan 5001836 49444
Novi 5004062, Michigan 5001836 48374
Novi 5004062, Michigan 5001836 48377
Petoskey 5005484, Michigan 5001836 49770
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Port Huron 5006233, Michigan 5001836 48060
Reed City 5006946, Michigan 5001836 49677
Royal Oak 5007804, Michigan 5001836 48067
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Saginaw 5007989, Michigan 5001836 48601
Saint Joseph 5008327, Michigan 5001836 49085
Saint Joseph 5008327, Michigan 5001836 49085
Southfield 5010636, Michigan 5001836 48075
Sterling Heights 5011148, Michigan 5001836 48312
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248-551-7695
Tawas City 5011900, Michigan 5001836 48764
Traverse City 5012495, Michigan 5001836 49684
Troy 5012639, Michigan 5001836 48084
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248-551-7695
Troy 5012639, Michigan 5001836 48085
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248-551-7695
Troy 5012639, Michigan 5001836 48098
Site Public Contact
248-551-7695
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
West Bloomfield 7259621, Michigan 5001836 48322
Wyoming 5015618, Michigan 5001836 49519
Ypsilanti 5015688, Michigan 5001836 48106
Ypsilanti 5015688, Michigan 5001836 48197
Aitkin 5015978, Minnesota 5037779 56431
Baxter 5017396, Minnesota 5037779 56425
Site Public Contact
218-828-2880
Bemidji 5017822, Minnesota 5037779 56601
Brainerd 5019116, Minnesota 5037779 56401
Burnsville 5019767, Minnesota 5037779 55337
Coon Rapids 5022025, Minnesota 5037779 55433
Deer River 5024099, Minnesota 5037779 56636
Detroit Lakes 5024237, Minnesota 5037779 56501
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Edina 5025264, Minnesota 5037779 55435
Ely 5025627, Minnesota 5037779 55731
Site Public Contact
218-365-7900
Fosston 5027191, Minnesota 5037779 56542
Hibbing 5030005, Minnesota 5037779 55746
Site Public Contact
218-786-3308
International Falls 5031404, Minnesota 5037779 56649
Site Public Contact
218-283-9431
Mankato 5036420, Minnesota 5037779 56001
Site Public Contact
855-776-0015
Maple Grove 5036493, Minnesota 5037779 55369
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55415
Monticello 5038045, Minnesota 5037779 55362
Moose Lake 5038132, Minnesota 5037779 55767
Site Public Contact
218-485-4481
New Ulm 5039173, Minnesota 5037779 56073
Park Rapids 5040822, Minnesota 5037779 56470
Pequot Lakes 5041146, Minnesota 5037779 56472
Site Public Contact
218-568-4416
Pine River 5041664, Minnesota 5037779 56474
Site Public Contact
218-587-4416
Princeton 5042360, Minnesota 5037779 55371
Robbinsdale 5043439, Minnesota 5037779 55422
Rochester 5043473, Minnesota 5037779 55905
Site Public Contact
855-776-0015
Saint Cloud 5044407, Minnesota 5037779 56303
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Sandstone 5045908, Minnesota 5037779 55072
Shakopee 5046997, Minnesota 5037779 55379
Staples 5048555, Minnesota 5037779 56479
Site Public Contact
218-894-7870
Stillwater 5048814, Minnesota 5037779 55082
Thief River Falls 5049970, Minnesota 5037779 56701
Site Public Contact
605-312-3320
Virginia 5051468, Minnesota 5037779 55792
Waconia 5051640, Minnesota 5037779 55387
Willmar 5052916, Minnesota 5037779 56201
Woodbury 5053358, Minnesota 5037779 55125
Worthington 5053460, Minnesota 5037779 56187
Site Public Contact
605-312-3320
Wyoming 5053526, Minnesota 5037779 55092
Columbus 4422442, Mississippi 4436296 39705
Grenada 4428539, Mississippi 4436296 38901
New Albany 4438121, Mississippi 4436296 38652
Oxford 4440076, Mississippi 4436296 38655
Southhaven 4446702, Mississippi 4436296 38671
Ballwin 4375663, Missouri 4398678 63011
Site Public Contact
888-446-3729
Bolivar 4377835, Missouri 4398678 65613
Branson 4378219, Missouri 4398678 65616
Site Public Contact
417-269-4520
Cape Girardeau 4379966, Missouri 4398678 63703
Site Public Contact
888-446-3729
Cape Girardeau 4379966, Missouri 4398678 63703
City of Saint Peters 4407237, Missouri 4398678 63376
Columbia 4381982, Missouri 4398678 65212
Site Public Contact
573-882-7440
Creve Coeur 4382837, Missouri 4398678 63141
Farmington 4386289, Missouri 4398678 63640
Site Public Contact
314-996-5569
Joplin 4392768, Missouri 4398678 64804
Joplin 4392768, Missouri 4398678 64804
Kansas City 4393217, Missouri 4398678 64108
Site Public Contact
816-404-4375
Kansas City 4393217, Missouri 4398678 64154
Lee's Summit 4394870, Missouri 4398678 64064
North Kansas City 4400860, Missouri 4398678 64116
Osage Beach 4402040, Missouri 4398678 65065
Rolla 4406282, Missouri 4398678 65401
Site Public Contact
573-458-6379
Rolla 4406282, Missouri 4398678 65401
Saint Joseph 4407010, Missouri 4398678 64506
Sainte Genevieve 4407294, Missouri 4398678 63670
Site Public Contact
314-996-5569
Springfield 4409896, Missouri 4398678 65804
Site Public Contact
417-269-4520
Springfield 4409896, Missouri 4398678 65807
Site Public Contact
417-269-4520
St Louis 4407066, Missouri 4398678 63109
Site Public Contact
888-446-3729
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63129
St Louis 4407066, Missouri 4398678 63131
Site Public Contact
314-996-5569
St Louis 4407066, Missouri 4398678 63136
St Louis 4407066, Missouri 4398678 63141
Site Public Contact
314-251-7066
Sullivan 4410669, Missouri 4398678 63080
Site Public Contact
314-996-5569
Sunset Hills 4410836, Missouri 4398678 63127
Site Public Contact
314-996-5569
Washington 4413621, Missouri 4398678 63090
Site Public Contact
636-390-1600
Anaconda 5637146, Montana 5667009 59711
Billings 5640350, Montana 5667009 59101
Billings 5640350, Montana 5667009 59102
Site Public Contact
800-648-6274
Billings 5640350, Montana 5667009 59106
Site Public Contact
406-238-6685
Bozeman 5641727, Montana 5667009 59715
Butte 5642934, Montana 5667009 59701
Site Public Contact
406-723-2621
Great Falls 5655240, Montana 5667009 59405
Great Falls 5655240, Montana 5667009 59405
Havre 5656497, Montana 5667009 59501
Kalispell 5660340, Montana 5667009 59901
Missoula 5666639, Montana 5667009 59802
Missoula 5666639, Montana 5667009 59804
Bellevue 5063805, Nebraska 5073708 68123
Grand Island 5069297, Nebraska 5073708 68803
Kearney 5071348, Nebraska 5073708 68847
Omaha 5074472, Nebraska 5073708 68118
Site Public Contact
402-559-5600
Omaha 5074472, Nebraska 5073708 68122
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68130
Omaha 5074472, Nebraska 5073708 68131
Omaha 5074472, Nebraska 5073708 68198
Carson City 5501344, Nevada 5509151 89703
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Las Vegas 5506956, Nevada 5509151 89074
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89103
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89119
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89135
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89169
Las Vegas 5506956, Nevada 5509151 89169
Pahrump 5509851, Nevada 5509151 89048
Reno 5511077, Nevada 5509151 89502
Reno 5511077, Nevada 5509151 89503
Reno 5511077, Nevada 5509151 89509
Lebanon 5088597, New Hampshire 5090174 03756
Camden 4501018, New Jersey 5101760 08103
Site Public Contact
856-325-6757
Cherry Hill 4501198, New Jersey 5101760 08002
Englewood 5097672, New Jersey 5101760 07631
Site Public Contact
201-894-3456
Hackensack 5098706, New Jersey 5101760 07601
Site Public Contact
551-996-2897
Hamilton 5098765, New Jersey 5101760 08690
Site Public Contact
609-631-6946
Jersey City 5099836, New Jersey 5101760 07302
Lakewood 5100280, New Jersey 5101760 08701
Livingston 5100572, New Jersey 5101760 07039
Long Branch 5100619, New Jersey 5101760 07740
Moorestown 4503106, New Jersey 5101760 08057
Morristown 5101427, New Jersey 5101760 07960
Site Public Contact
973-971-5900
New Brunswick 5101717, New Jersey 5101760 08903
Site Public Contact
732-235-7356
Newark 5101798, New Jersey 5101760 07112
Paramus 5102387, New Jersey 5101760 07652
Pennington 5102535, New Jersey 5101760 08534
Ridgewood 5103269, New Jersey 5101760 07450
Sewell 4504048, New Jersey 5101760 08080
Somerville 5104774, New Jersey 5101760 08876
Summit 5105127, New Jersey 5101760 07902
Site Public Contact
908-522-2043
Teaneck 5105262, New Jersey 5101760 07666
Site Public Contact
201-833-6312
Toms River 4504476, New Jersey 5101760 08755
Voorhees Township 5105860, New Jersey 5101760 08043
Site Public Contact
856-325-6757
Voorhees Township 5105860, New Jersey 5101760 08043
Albuquerque 5454711, New Mexico 5481136 87106
Albuquerque 5454711, New Mexico 5481136 87110
Las Cruces 5475352, New Mexico 5481136 88011
Rio Rancho 5487811, New Mexico 5481136 87124
Bay Shore 5108169, New York 5128638 11706
Site Public Contact
516-734-8896
Bronxville 5110269, New York 5128638 10708
Brooklyn 5110302, New York 5128638 11215
Brooklyn 5110302, New York 5128638 11220
Buffalo 5110629, New York 5128638 14263
Cortlandt Manor 11811570, New York 5128638 10567
Site Public Contact
877-697-9355
East Hills 5115904, New York 5128638 11548
Flushing 5117472, New York 5128638 11355
Glens Falls 5118693, New York 5128638 12801
Site Public Contact
518-926-6700
Greenlawn 5119377, New York 5128638 11740
Site Public Contact
516-734-8896
Lake Success 5123853, New York 5128638 11042
Site Public Contact
516-734-8896
Mineola 5127134, New York 5128638 11501
Mount Kisco 5127744, New York 5128638 10549
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10065
Site Public Contact
212-434-4460
New York 5128581, New York 5128638 10065
Site Public Contact
212-746-1848
New York 5128581, New York 5128638 10075
Site Public Contact
516-734-8896
Rochester 5134086, New York 5128638 14623
Rochester 5134086, New York 5128638 14642
Site Public Contact
585-275-5830
Sleepy Hollow 5138371, New York 5128638 10591
Site Public Contact
914-366-1600
Staten Island 5139568, New York 5128638 10305
Site Public Contact
718-226-8888
Stony Brook 5139865, New York 5128638 11794
Site Public Contact
800-862-2215
West Islip 5143866, New York 5128638 11795
Site Public Contact
516-326-7514
Albemarle 4452303, North Carolina 4482348 28002
Site Public Contact
800-804-9376
Asheboro 4453035, North Carolina 4482348 27205
Burlington 4458228, North Carolina 4482348 27215
Cary 4459467, North Carolina 4482348 27518
Cary 4459467, North Carolina 4482348 27518
Chapel Hill 4460162, North Carolina 4482348 27599
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Bismarck 5688025, North Dakota 5690763 58501
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Lawton 4540737, Oklahoma 4544379 73505
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Oklahoma City 4544349, Oklahoma 4544379 73104
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Baker City 5712169, Oregon 5744337 97814
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Allentown 5178127, Pennsylvania 6254927 18103
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Danville 5186327, Pennsylvania 6254927 17822
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Providence 5224151, Rhode Island 5224323 02905
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Warwick 5225507, Rhode Island 5224323 02886
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Westerly 5225631, Rhode Island 5224323 02891
Bluffton 4571722, South Carolina 4597040 29910
Charleston 4574324, South Carolina 4597040 29425
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Hilton Head Island 4581832, South Carolina 4597040 29926-3827
Rock Hill 4593142, South Carolina 4597040 29732
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Spartanburg 4597200, South Carolina 4597040 29303
Union 4599214, South Carolina 4597040 29379
Aberdeen 5225857, South Dakota 5769223 57401
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Rapid City 5768233, South Dakota 5769223 57701
Sioux Falls 5231851, South Dakota 5769223 57104
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Yankton 5233053, South Dakota 5769223 57078
Collierville 4614748, Tennessee 4662168 38017
Germantown 4624601, Tennessee 4662168 38138
Knoxville 4634946, Tennessee 4662168 37920
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Memphis 4641239, Tennessee 4662168 38120
Amarillo 5516233, Texas 4736286 79106
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San Antonio 4726206, Texas 4736286 78229
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Farmington 5774662, Utah 5549030 84025
Salt Lake City 5780993, Utah 5549030 84106
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South Jordan 5781770, Utah 5549030 84009
Berlin Corners 5233780, Vermont 5242283 05602
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Burlington 5234372, Vermont 5242283 05401
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Burke 4749950, Virginia 6254928 22015
Charlottesville 4752031, Virginia 6254928 22908
Fishersville 4759120, Virginia 6254928 22939
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Lynchburg 4771075, Virginia 6254928 24501
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Aberdeen 5785243, Washington 5815135 98520
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Bridgeport 4800081, West Virginia 4826850 26330
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Antigo 5244010, Wisconsin 5279468 54409
Appleton 5244080, Wisconsin 5279468 54911
Ashland 5244247, Wisconsin 5279468 54806
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Berlin 5245497, Wisconsin 5279468 54923
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Green Bay 5254962, Wisconsin 5279468 54301
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Green Bay 5254962, Wisconsin 5279468 54301
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Hayward 5255882, Wisconsin 5279468 54843
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218-568-4416
Janesville 5257754, Wisconsin 5279468 53548
Johnson Creek 5257996, Wisconsin 5279468 53038
Kenosha 5258393, Wisconsin 5279468 53142
La Crosse 5258957, Wisconsin 5279468 54601
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855-776-0015
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Madison 5261457, Wisconsin 5279468 53718
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262-257-5100
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Milwaukee 5263045, Wisconsin 5279468 53233
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414-805-0505
Oconto Falls 5265522, Wisconsin 5279468 54154
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Spooner 5274034, Wisconsin 5279468 54801
Stevens Point 5274644, Wisconsin 5279468 54481
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Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Summit, Wisconsin 5279468 53066
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Two Rivers 5276609, Wisconsin 5279468 54241
Waupaca 5278083, Wisconsin 5279468 54981
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Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Cody 5821593, Wyoming 5843591 82414
Bayamón 4562831, Puerto Rico 00959-5060
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787-395-7085
Bayamón 4562831, Puerto Rico 00961
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Manatí 4566137, Puerto Rico 00674
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San Juan 4568127, Puerto Rico 00917
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San Juan 4568127, Puerto Rico 00927
San Juan 4568127, Puerto Rico 00927
San Juan 4568127, Puerto Rico 00936
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787-763-1296
More Details
- NCT ID
- NCT05879926
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
Younger age at diagnosis is an adverse prognostic factor in early breast cancer: women who are less than 35 years of age at diagnosis are more likely to die from their disease than their older counterparts following standard treatments. There remains a pressing need for advancements in therapeutic options for this patient population. One increasingly utilized option is ovarian suppression, which was first reported as treatment for advanced breast cancer in 1896 and has been examined in a multitude of clinical trials over the past century. As chemotherapeutic options became more commonplace for breast cancer therapy, however, the role of ovarian suppression became uncertain. In the pre-genomic era, several studies evaluated the role of ovarian suppression compared to chemotherapy, with conflicting results. These studies either looked at ovarian suppression alone or at tamoxifen compared to chemotherapy. A meta-analysis examining LHRH-agonists (luteinizing hormone-releasing hormone) in the Early Breast Cancer Overview group (LHRH-agonists in Early Breast Cancer Overview group 2007) showed that when LHRH-agonists were added to tamoxifen, chemotherapy, or both, there was a 12.7% reduction in the risk of recurrence and a 15.1% reduction in the risk of death. When compared to chemotherapy, LHRH-agonists appeared to be equally as effective, especially if patients were less than 40 years of age. These older studies, conducted in the pre-taxane/anthracycline era, typically used CMF (cyclophosphamide, methotrexate, and fluorouracil) chemotherapy, and were designed prior to the use of genomic assays .