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. |
|
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Baltimore, Maryland 21239
Baltimore, Maryland 21244
Baltimore, Maryland 21287
Bel Air, Maryland 21015
Easton, Maryland 21601
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Frederick, Maryland 21702
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Gaithersburg, Maryland 20879
Glen Burnie, Maryland 21061
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Kensington, Maryland 20895
Largo, Maryland 20774
Lutherville, Maryland 21093
Olney, Maryland 20832
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Randallstown, Maryland 21133
Beverly, Massachusetts 01915
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978-922-3000
Boston, Massachusetts 02111
Boston, Massachusetts 02215
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Boston, Massachusetts 02215
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Burlington, Massachusetts 01805
Gloucester, Massachusetts 01930
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Lowell, Massachusetts 01854
Newburyport, Massachusetts 01950
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Peabody, Massachusetts 01960
South Weymouth, Massachusetts 02190
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781-624-5000
Springfield, Massachusetts 01199
Stoneham, Massachusetts 02180
Winchester, Massachusetts 01890
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Alma, Michigan 48801
Alpena, Michigan 49707
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48109
Battle Creek, Michigan 49017
Bay City, Michigan 48706
Brighton, Michigan 48114
Brighton, Michigan 48114
Brighton, Michigan 48116
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Brownstown, Michigan 48183
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clinton Township, Michigan 48038
Dearborn, Michigan 48124
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248-551-7695
Dearborn, Michigan 48126
Detroit, Michigan 48201
Detroit, Michigan 48202
Detroit, Michigan 48236
East China Township, Michigan 48054
Escanaba, Michigan 49829
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48336
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Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48532
Gladwin, Michigan 48624
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grosse Pointe Woods, Michigan 48236
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Iron Mountain, Michigan 49801
Jackson, Michigan 49201
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49009
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Kalamazoo, Michigan 49048
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Lansing, Michigan 48910
Lansing, Michigan 48912
Lapeer, Michigan 48446
Livonia, Michigan 48154
Macomb, Michigan 48044
Macomb, Michigan 48044
Marquette, Michigan 49855
Marquette, Michigan 49855
Midland, Michigan 48670
Mount Clemens, Michigan 48043
Mount Pleasant, Michigan 48858
Muskegon, Michigan 49444
Niles, Michigan 49120
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616-391-1230
Norton Shores, Michigan 49444
Novi, Michigan 48374
Novi, Michigan 48377
Petoskey, Michigan 49770
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Port Huron, Michigan 48060
Reed City, Michigan 49677
Royal Oak, Michigan 48067
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Saginaw, Michigan 48601
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Southfield, Michigan 48075
Sterling Heights, Michigan 48312
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Tawas City, Michigan 48764
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Troy, Michigan 48085
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Troy, Michigan 48098
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Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
West Bloomfield, Michigan 48322
Wyoming, Michigan 49519
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Baxter, Minnesota 56425
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218-828-2880
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Coon Rapids, Minnesota 55433
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Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
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Edina, Minnesota 55435
Ely, Minnesota 55731
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Fosston, Minnesota 56542
Hibbing, Minnesota 55746
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International Falls, Minnesota 56649
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Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Monticello, Minnesota 55362
Moose Lake, Minnesota 55767
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New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Pequot Lakes, Minnesota 56472
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218-568-4416
Pine River, Minnesota 56474
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Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Rochester, Minnesota 55905
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855-776-0015
Saint Cloud, Minnesota 56303
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Staples, Minnesota 56479
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Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
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Virginia, Minnesota 55792
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Woodbury, Minnesota 55125
Worthington, Minnesota 56187
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Wyoming, Minnesota 55092
Columbus, Mississippi 39705
Grenada, Mississippi 38901
New Albany, Mississippi 38652
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Ballwin, Missouri 63011
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888-446-3729
Bolivar, Missouri 65613
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417-269-4520
Cape Girardeau, Missouri 63703
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Cape Girardeau, Missouri 63703
City of Saint Peters, Missouri 63376
Columbia, Missouri 65212
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573-882-7440
Creve Coeur, Missouri 63141
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Joplin, Missouri 64804
Joplin, Missouri 64804
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816-404-4375
Kansas City, Missouri 64116
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Kansas City, Missouri 64154
Lee's Summit, Missouri 64064
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Osage Beach, Missouri 65065
Rolla, Missouri 65401
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Rolla, Missouri 65401
Saint Joseph, Missouri 64506
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St Louis, Missouri 63109
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St Louis, Missouri 63110
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Sullivan, Missouri 63080
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Sunset Hills, Missouri 63127
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Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Billings, Montana 59102
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800-648-6274
Billings, Montana 59106
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406-238-6685
Bozeman, Montana 59715
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406-723-2621
Great Falls, Montana 59405
Great Falls, Montana 59405
Havre, Montana 59501
Helena, Montana 59601
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Bellevue, Nebraska 68123
Grand Island, Nebraska 68803
Hastings, Nebraska 68901
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402-460-5899
Kearney, Nebraska 68845
Kearney, Nebraska 68847
Omaha, Nebraska 68118
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Omaha, Nebraska 68122
Omaha, Nebraska 68124
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Omaha, Nebraska 68198
Carson City, Nevada 89703
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Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
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Henderson, Nevada 89074
Henderson, Nevada 89074
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Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89135
Las Vegas, Nevada 89144
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Las Vegas, Nevada 89144
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Reno, Nevada 89509
Lebanon, New Hampshire 03756
Camden, New Jersey 08103
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Cherry Hill, New Jersey 08002
Elizabeth, New Jersey 07207
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Englewood, New Jersey 07631
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Hackensack, New Jersey 07601
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Hamilton, New Jersey 08690
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609-631-6946
Jersey City, New Jersey 07302
Lakewood, New Jersey 08701
Livingston, New Jersey 07039
Long Branch, New Jersey 07740
Moorestown, New Jersey 08057
Morristown, New Jersey 07960
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New Brunswick, New Jersey 08903
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Newark, New Jersey 07112
Paramus, New Jersey 07652
Pennington, New Jersey 08534
Ridgewood, New Jersey 07450
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Summit, New Jersey 07902
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Teaneck, New Jersey 07666
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Toms River, New Jersey 08755
Voorhees Township, New Jersey 08043
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Voorhees Township, New Jersey 08043
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87110
Las Cruces, New Mexico 88011
Rio Rancho, New Mexico 87124
Bay Shore, New York 11706
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516-734-8896
Bronxville, New York 10708
Brooklyn, New York 11215
Brooklyn, New York 11220
Buffalo, New York 14263
Cortlandt Manor, New York 10567
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877-697-9355
Flushing, New York 11355
Glens Falls, New York 12801
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518-926-6700
Greenlawn, New York 11740
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Lake Success, New York 11042
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Mineola, New York 11501
Mount Kisco, New York 10549
New York, New York 10016
New York, New York 10032
New York, New York 10065
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New York, New York 10065
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New York, New York 10075
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Poughkeepsie, New York 12601
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Rochester, New York 14623
Rochester, New York 14642
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585-275-5830
Sleepy Hollow, New York 10591
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914-366-1600
Staten Island, New York 10305
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718-226-8888
Stony Brook, New York 11794
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800-862-2215
White Plains, New York 10601
Albemarle, North Carolina 28002
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800-804-9376
Asheboro, North Carolina 27205
Burlington, North Carolina 27215
Cary, North Carolina 27518
Cary, North Carolina 27518
Cary, North Carolina 27518
Chapel Hill, North Carolina 27599
Charlotte, North Carolina 28203
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Charlotte, North Carolina 28204
Charlotte, North Carolina 28210
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Charlotte, North Carolina 28211
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Charlotte, North Carolina 28262
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Charlotte, North Carolina 28277
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Clemmons, North Carolina 27012
Clemmons, North Carolina 27012
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888-716-9259
Concord, North Carolina 28025
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800-804-9376
Durham, North Carolina 27710
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888-275-3853
Forest City, North Carolina 28043
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Garner, North Carolina 27529
Gastonia, North Carolina 28054
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800-804-9376
Greensboro, North Carolina 27403
Greensboro, North Carolina 27403
Greensboro, North Carolina 27410
Greenville, North Carolina 27834
Hillsborough, North Carolina 27278
Huntersville, North Carolina 28078
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980-442-2000
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
Kernersville, North Carolina 27284
Lincolnton, North Carolina 28092
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Matthews, North Carolina 28104
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980-442-0600
Matthews, North Carolina 28105
Matthews, North Carolina 28105
Monroe, North Carolina 28112
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980-442-2000
Mooresville, North Carolina 28117
Mount Airy, North Carolina 27030
North Wilkesboro, North Carolina 28659
Pinehurst, North Carolina 28374
Raleigh, North Carolina 27607
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919-785-4878
Raleigh, North Carolina 27607
Raleigh, North Carolina 27614
Reidsville, North Carolina 27320
Salisbury, North Carolina 28144
Salisbury, North Carolina 28144
Shelby, North Carolina 28150
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Statesville, North Carolina 28625
Thomasville, North Carolina 27360
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27157
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336-713-6771
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58103
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605-312-3320
Fargo, North Dakota 58104
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800-437-4010
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Jamestown, North Dakota 58401
Akron, Ohio 44304
Akron, Ohio 44307
Alliance, Ohio 44601
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330-363-1250
Athens, Ohio 45701
Barberton, Ohio 44203
Canton, Ohio 44710
Centerville, Ohio 45459
Cincinnati, Ohio 45219
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513-585-0844
Cincinnati, Ohio 45220
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44111
Cleveland, Ohio 44195
Columbus, Ohio 43210
Columbus, Ohio 43214
Columbus, Ohio 43214
Columbus, Ohio 43215
Columbus, Ohio 43228
Dayton, Ohio 45409
Dayton, Ohio 45409
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Dayton, Ohio 45415
Delaware, Ohio 43015
Delaware, Ohio 43015
Dublin, Ohio 43016
Dublin, Ohio 43016
Franklin, Ohio 45005-1066
Greenville, Ohio 45331
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Independence, Ohio 44131
Mansfield, Ohio 44903
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Marion, Ohio 43302
Mayfield Heights, Ohio 44124
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Pickerington, Ohio 43147
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Sylvania, Ohio 43560
Toledo, Ohio 43606
Troy, Ohio 45373
Warrensville Heights, Ohio 44122
Westerville, Ohio 43082
Wooster, Ohio 44691
Lawton, Oklahoma 73505
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877-231-4440
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
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405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Hood River, Oregon 97031
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97227
Redmond, Oregon 97756
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Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18104
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610-776-4714
Bethlehem, Pennsylvania 18015
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484-503-4151
Bethlehem, Pennsylvania 18017
Bryn Mawr, Pennsylvania 19010
Chadds Ford, Pennsylvania 19317
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
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717-217-6020
Coaldale, Pennsylvania 18218
Cranberry Township, Pennsylvania 16066
Danville, Pennsylvania 17822
Dickson City, Pennsylvania 18519
East Norriton, Pennsylvania 19401
East Stroudsburg, Pennsylvania 18301
Easton, Pennsylvania 18045
Ephrata, Pennsylvania 17522
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Erie, Pennsylvania 16505
Erie, Pennsylvania 16544
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814-452-5000
Farrell, Pennsylvania 16121
Furlong, Pennsylvania 18925
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215-794-2700
Gettysburg, Pennsylvania 17325
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Greensburg, Pennsylvania 15601
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Harrisburg, Pennsylvania 17109
Hazleton, Pennsylvania 18201
Hershey, Pennsylvania 17033-0850
Jefferson Hills, Pennsylvania 15025
Lebanon, Pennsylvania 17042
Lewisburg, Pennsylvania 17837
Meadowbrook, Pennsylvania 19046
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215-938-3555
Meadville, Pennsylvania 16335
Mechanicsburg, Pennsylvania 17050
Media, Pennsylvania 19063
Monroeville, Pennsylvania 15146
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412-858-7746
Monroeville, Pennsylvania 15146
New Castle, Pennsylvania 16105
Paoli, Pennsylvania 19301
Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19111
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Philadelphia, Pennsylvania 19114
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Pittsburgh, Pennsylvania 15212
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Pittsburgh, Pennsylvania 15243
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Pottsville, Pennsylvania 17901
Quakertown, Pennsylvania 18951
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Sayre, Pennsylvania 18840
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Scranton, Pennsylvania 18510
Stroudsburg, Pennsylvania 18360
West Reading, Pennsylvania 19611
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Wexford, Pennsylvania 15090
Wilkes-Barre, Pennsylvania 18711
Williamsport, Pennsylvania 17754
Willow Grove, Pennsylvania 19090
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York, Pennsylvania 17403
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York, Pennsylvania 17403
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Providence, Rhode Island 02905
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401-274-1122
Warwick, Rhode Island 02886
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Westerly, Rhode Island 02891
Bluffton, South Carolina 29910
Boiling Springs, South Carolina 29316
Charleston, South Carolina 29425
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Greenville, South Carolina 29601
Greenville, South Carolina 29605
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Greer, South Carolina 29650
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Hilton Head Island, South Carolina 29926-3827
Rock Hill, South Carolina 29732
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Seneca, South Carolina 29672
Spartanburg, South Carolina 29303
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Aberdeen, South Dakota 57401
Mitchell, South Dakota 57301
Pierre, South Dakota 57501
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57117-5134
Yankton, South Dakota 57078
Collierville, Tennessee 38017
Germantown, Tennessee 38138
Knoxville, Tennessee 37920
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865-544-9773
Memphis, Tennessee 38120
Amarillo, Texas 79106
Conroe, Texas 77384
Galveston, Texas 77555-0565
Houston, Texas 77026-1967
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713-566-5000
Houston, Texas 77030
Houston, Texas 77030
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Houston, Texas 77030
Houston, Texas 77079
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League City, Texas 77573
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Lubbock, Texas 79415
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806-775-8590
Lubbock, Texas 79430
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San Antonio, Texas 78229
Sugar Land, Texas 77478
Farmington, Utah 84025
Salt Lake City, Utah 84106
Salt Lake City, Utah 84112
South Jordan, Utah 84009
Berlin Corners, Vermont 05602
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802-225-5400
Burlington, Vermont 05401
Burlington, Vermont 05405
Saint Johnsbury, Vermont 05819
Burke, Virginia 22015
Charlottesville, Virginia 22908
Fishersville, Virginia 22939
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540-332-5960
Lynchburg, Virginia 24501
McLean, Virginia 22102
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Midlothian, Virginia 23113
Midlothian, Virginia 23114
Richmond, Virginia 23223
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Richmond, Virginia 23230
Richmond, Virginia 23235
Richmond, Virginia 23298
South Hill, Virginia 23970
Woodbridge, Virginia 22192
Aberdeen, Washington 98520
Bellevue, Washington 98004
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425-454-2148
Bellingham, Washington 98225
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Kirkland, Washington 98034
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425-899-6000
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Renton, Washington 98055
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Seattle, Washington 98109
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800-804-8824
Seattle, Washington 98122-5711
Seattle, Washington 98122
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206-606-5800
Seattle, Washington 98195
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Sedro-Woolley, Washington 98284
Silverdale, Washington 98383
Spokane, Washington 99202
Spokane, Washington 99216
Spokane, Washington 99218
Walla Walla, Washington 99362
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Bridgeport, West Virginia 26330
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Princeton, West Virginia 24740
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304-487-7515
Wheeling, West Virginia 26003
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Antigo, Wisconsin 54409
Appleton, Wisconsin 54911
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Berlin, Wisconsin 54923
Burlington, Wisconsin 53105
Chippewa Falls, Wisconsin 54729
Cudahy, Wisconsin 53110
Eau Claire, Wisconsin 54701
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54301
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920-435-8326
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Hayward, Wisconsin 54843
Hayward, Wisconsin 54843
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218-568-4416
Janesville, Wisconsin 53548
Johnson Creek, Wisconsin 53038
Kenosha, Wisconsin 53142
Ladysmith, Wisconsin 54848
Madison, Wisconsin 53718
Madison, Wisconsin 53792
Marinette, Wisconsin 54143
Marshfield, Wisconsin 54449
Medford, Wisconsin 54451
Menomonee Falls, Wisconsin 53051
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262-257-5100
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
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414-805-3666
Milwaukee, Wisconsin 53233
Minocqua, Wisconsin 54548
Neenah, Wisconsin 54956
Neillsville, Wisconsin 54456
New Richmond, Wisconsin 54017
Oak Creek, Wisconsin 53154
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414-805-0505
Oconto Falls, Wisconsin 54154
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53406
Rhinelander, Wisconsin 54501
Rice Lake, Wisconsin 54868
Shawano, Wisconsin 54166
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Spooner, Wisconsin 54801
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Summit, Wisconsin 53066
Superior, Wisconsin 54880
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701-364-6272
Two Rivers, Wisconsin 54241
Waupaca, Wisconsin 54981
Wausau, Wisconsin 54401
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877-405-6866
Wausau, Wisconsin 54401
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
West Bend, Wisconsin 53095
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414-805-0505
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
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715-422-7718
Wisconsin Rapids, Wisconsin 54494
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Bayamón, Puerto Rico 00959-5060
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787-395-7085
Bayamón, Puerto Rico 00961
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Manatí, Puerto Rico 00674
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787-621-4397
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San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00936
Site Public Contact
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 .