De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
Purpose
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
Condition
- Stage I Breast Cancer
Eligibility
- Eligible Ages
- Between 50 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information. - The patient must have an ECOG performance status of 0 or 1. - The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS 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. (Patients with margins positive for LCIS are eligible without additional resection.) - The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. - Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection). - The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: - By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm). - By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.) - Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen. ** For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry/Step 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis. *** The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection. - An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary "Low" category will meet this eligibility criteria and an Oncotype RS does not need to be performed. - The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive. - The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines. - Patients may be premenopausal or postmenopausal at the time of pre-entry/Step 1. For study purposes, postmenopausal is defined as: - Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry/Step 1; or a documented hysterectomy; or - Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry/Step 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Documented bilateral oophorectomy. - The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry/Step 1 must be no more than 70 days. - The patient must have recovered from surgery with the incision completely healed and no signs of infection. - Bilateral mammogram or MRI within 6 months prior to pre-entry/Step 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.
Exclusion Criteria
- • Definitive clinical or radiologic evidence of metastatic disease. - pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer. - Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease. - Patient had a mastectomy. - Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. - Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. - Non-epithelial breast malignancies such as sarcoma or lymphoma. - Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.) - Paget's disease of the nipple. - Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.) - Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.) - Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.) - Treatment plan that includes regional nodal irradiation. - Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1. - History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1. - Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. ** Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization/Step 2) for this diagnosis after the core biopsy (and can continue postoperatively if: - the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND - the patient had not initiated endocrine therapy prior to core biopsy tissue collection. *** This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry/Step 1). - Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible. - Prior breast or thoracic RT for any condition. - Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. - Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry/Step 1.) - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications. - Psychiatric or addictive disorders or 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. - Use of any investigational product within 30 days prior to pre-entry/Step 1.
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: Breast Radiation Therapy + Endocrine Therapy |
Radiation therapy to the breast and hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily |
|
Active Comparator Arm 2: No Breast Radiation Therapy + Endocrine Therapy |
No radiation therapy, only hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily |
|
Recruiting Locations
Kingman 5301067, Arizona 5551752 86401
Phoenix 5308655, Arizona 5551752 85004
Little Rock 4119403, Arkansas 4099753 72205
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Coeur d'Alene 5589173, Idaho 5596512 83814
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Albert Lea 5016024, Minnesota 5037779 56007
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Gulfport 4428667, Mississippi 4436296 39502
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Billings 5640350, Montana 5667009 59101
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Great Falls 5655240, Montana 5667009 59405
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Bellevue 5063805, Nebraska 5073708 68123
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Omaha 5074472, Nebraska 5073708 68118
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Omaha 5074472, Nebraska 5073708 68198
Henderson 5505411, Nevada 5509151 89052
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Lebanon 5088597, New Hampshire 5090174 03756
Basking Ridge 5095409, New Jersey 5101760 07920
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Teaneck 5105262, New Jersey 5101760 07666
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Albuquerque 5454711, New Mexico 5481136 87106
Astoria 5107464, New York 5128638 11102
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Binghamton 5109177, New York 5128638 13905
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Lake Success 5123853, New York 5128638 11042
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Mount Kisco 5127744, New York 5128638 10549
New York 5128581, New York 5128638 10003
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Oswego 5130081, New York 5128638 13126
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Uniondale 5141927, New York 5128638 11553
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Verona 5142333, New York 5128638 13478
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Albemarle 4452303, North Carolina 4482348 28002
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Asheville 4453066, North Carolina 4482348 28801
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Mooresville 4480125, North Carolina 4482348 28117
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Statesville 4493316, North Carolina 4482348 28625
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Winston-Salem 4499612, North Carolina 4482348 27103
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Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Grand Forks 5059429, North Dakota 5690763 58201
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Akron 5145476, Ohio 5165418 44304
Akron 5145476, Ohio 5165418 44307
Avon 5146277, Ohio 5165418 44011
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Barberton 5146491, Ohio 5165418 44203
Beachwood 5146711, Ohio 5165418 44122
Beavercreek 4506008, Ohio 5165418 45431
Canton 5149222, Ohio 5165418 44708
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Canton 5149222, Ohio 5165418 44710
Centerville 4508204, Ohio 5165418 45459
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Cincinnati 4508722, Ohio 5165418 45219
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Columbus 4509177, Ohio 5165418 43210
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Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
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Dayton 4509884, Ohio 5165418 45415
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Delaware 5151891, Ohio 5165418 43015
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Dublin 5152333, Ohio 5165418 43016
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
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Franklin 4512203, Ohio 5165418 45005-1066
Franklin 4512203, Ohio 5165418 45005
Greenville 5156493, Ohio 5165418 45331
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Grove City 4513409, Ohio 5165418 43123
Kettering 4515843, Ohio 5165418 45409
Kettering 4515843, Ohio 5165418 45429
Mansfield 5161723, Ohio 5165418 44903
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Marion 5161902, Ohio 5165418 43302
Mayfield Heights 5162188, Ohio 5165418 44124
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Parma 5166177, Ohio 5165418 44129
Ravenna 5167737, Ohio 5165418 44266
Sandusky 5170691, Ohio 5165418 44870
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Strongsville 5173237, Ohio 5165418 44136
Sylvania 5173572, Ohio 5165418 43560
Toledo 5174035, Ohio 5165418 43606
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Wooster 5177358, Ohio 5165418 44691
Zanesville 4528923, Ohio 5165418 43701
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73120
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Clackamas 5719308, Oregon 5744337 97015
Gresham 5729485, Oregon 5744337 97030
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503-413-2150
Newberg 5742726, Oregon 5744337 97132
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97210
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Allentown 5178127, Pennsylvania 6254927 18104
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Bethlehem 5180225, Pennsylvania 6254927 18015
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Chambersburg 4557109, Pennsylvania 6254927 17201
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Dunmore 5187542, Pennsylvania 6254927 18512
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Easton 5188140, Pennsylvania 6254927 18045
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Stroudsburg 5214543, Pennsylvania 6254927 18360
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York 4562407, Pennsylvania 6254927 17403
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Providence 5224151, Rhode Island 5224323 02903
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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
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Rock Hill 4593142, South Carolina 4597040 29730
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Sioux Falls 5231851, South Dakota 5769223 57104
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Knoxville 4634946, Tennessee 4662168 37920
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Nashville 4644585, Tennessee 4662168 37203
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Nashville 4644585, Tennessee 4662168 37204
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Abilene 4669635, Texas 4736286 79601
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Baytown 4672731, Texas 4736286 77521
Conroe 4682991, Texas 4736286 77384
Galveston 4692883, Texas 4736286 77555-0565
Houston 4699066, Texas 4736286 77030
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Houston 4699066, Texas 4736286 77030
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League City 4705692, Texas 4736286 77573
Lubbock 5525577, Texas 4736286 79415
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Nassau Bay 4713813, Texas 4736286 77058
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The Woodlands 4736476, Texas 4736286 77385
American Fork 5844096, Utah 5549030 84003
Cedar City 5536630, Utah 5549030 84720
Logan 5777544, Utah 5549030 84321
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Salt Lake City 5780993, Utah 5549030 84106
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Burlington 5234372, Vermont 5242283 05401
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Saint Johnsbury 5240656, Vermont 5242283 05819
Mechanicsville 4772566, Virginia 6254928 23116
Midlothian 4772943, Virginia 6254928 23114
Portsmouth 4779999, Virginia 6254928 23708-2197
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Richmond 4781708, Virginia 6254928 23226
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Bellingham 5786899, Washington 5815135 98225
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Edmonds 5793427, Washington 5815135 98026
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Huntington 4809537, West Virginia 4826850 25701
Antigo 5244010, Wisconsin 5279468 54409
Burlington 5247214, Wisconsin 5279468 53105
Eau Claire 5251436, Wisconsin 5279468 54701
Fond du Lac 5253352, Wisconsin 5279468 54937
Germantown 5254218, Wisconsin 5279468 53022
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Green Bay 5254962, Wisconsin 5279468 54301
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Johnson Creek 5257996, Wisconsin 5279468 53038
Kenosha 5258393, Wisconsin 5279468 53142
La Crosse 5258957, Wisconsin 5279468 54601
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Madison 5261457, Wisconsin 5279468 53718
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Medford 5262475, Wisconsin 5279468 54451
Menomonee Falls 5262630, Wisconsin 5279468 53051
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262-257-5100
Milwaukee 5263045, Wisconsin 5279468 53209
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Milwaukee 5263045, Wisconsin 5279468 53233
Minocqua 5263156, Wisconsin 5279468 54548
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Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Summit, Wisconsin 5279468 53066
Two Rivers 5276609, Wisconsin 5279468 54241
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Weston 5278693, Wisconsin 5279468 54476
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
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More Details
- NCT ID
- NCT04852887
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
Breast conservation therapy for early stage breast cancer has been an important achievement of oncology practice in the last half century and breast radiotherapy (RT) has been essential in its development. Several seminal randomized clinical trials conducted in the 1980's era demonstrated that breast radiotherapy following lumpectomy yielded overall survival outcomes equivalent to mastectomy for treatment of early stage invasive breast cancer leading to the National Institute of Health (NIH) Consensus Conference statement in 1991 supporting breast conservation treatment.This established lumpectomy with RT as an alternative to mastectomy and subsequently the rate of breast conservation for eligible breast cancer patients rose steadily. Shortly thereafter, investigators recognized that the toxicity, patient burden, and geographic barriers associated with the protracted treatment course for breast RT was a potential barrier to breast conservation utilization. Numerous phase III clinical trials were conducted randomizing women post lumpectomy to RT vs. observation aimed at identifying which cases did not derive a significant RT benefit. No such subsets of breast cancer patients were consistently identified, thereby solidifying the standard that breast conservation required both lumpectomy and RT. Two meta-analyses by the Early Breast Cancer Trialists Collaborative Group (EBCTCG) in 2005 and 2011 further reinforced the value of breast RT post lumpectomy by examining the relationship of local recurrence and breast cancer mortality relative to the use of breast RT post lumpectomy. In each analysis, it found for axillary node negative breast cancer patients undergoing breast conservation a small but consistent increase in breast cancer mortality when breast radiotherapy was omitted. As a result, breast RT after lumpectomy has become an established paradigm for breast conservation for early stage breast cancer and is recommended by the NCCN 2018 guidelines (as it has for nearly two decades) that are commonly used today by clinicians and health systems alike. The landscape of early stage breast cancer has changed dramatically over the past three decades since the establishment of breast conservation. Widespread screening with mammography has led to the diagnosis of smaller and earlier stage disease. All breast cancers are now routinely characterized by their hormone sensitivity based on the presence of estrogen and progesterone receptors on tumor cells within the biopsy or surgical specimen and presence of HER2 (human epidermal growth factor receptor 2) which has provided an additional means of stratifying breast cancer into distinct prognostic groups. Small, node negative invasive breast cancer that is hormone sensitive (HS) and HER2-negative has a lower overall recurrence rate (local, regional, and distant) than breast cancers characterized by more adverse clinical pathologic features. However, other than in a smaller subset of women greater than 70 years old, clinical trials in this HS population still demonstrated unacceptable local recurrence risks long term after lumpectomy alone emphasizing that clinical and pathologic features are insufficient for consistently identifying when RT can safely be omitted.