NCT04852887ClinicalTrials.gov

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer

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En resumen

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.

Fase 31670 participantes buscados832 centros4 países

Categorías

Oncología60%Endocrino y metabólico27%Dermatología13%

Registrado en 1 registro

ClinicalTrials.govNCT04852887Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2021-04-21; recorded start 2021-06-23
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 49 other studies in this databaseCounted from the lead sponsor named in the record (NRG Oncology)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: other.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 832 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,670 participants (target), run at 832 sites, across 4 countries.

How this score is built

Enrolment32/40
1,670 participants (target)
Site count25/25
832 sites
Country count7/15
4 countries
Planned duration10/10
Planned over about 244 months
Sponsor scale6/10
NRG Oncology has led 49 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

Stage I Breast Cancer

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	50 Years – 70 Years
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	1670 participantes buscados

Patrocinador y colaboradores

NRG Oncology Patrocinador
National Cancer Institute (NCI) Colaboradores

Grupos e intervenciones

Arm 1: Breast Radiation Therapy + Endocrine TherapyACTIVE_COMPARATOR
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
Arm 2: No Breast Radiation Therapy + Endocrine TherapyACTIVE_COMPARATOR
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

Intervenciones

Fármaco Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s).
Otro Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Post lumpectomy radiation therapy will be external beam radiation to either the whole breast + boost, partial breast irradiation, or Accelerated Partial Breast Irradiation that must begin within 12 weeks of the last breast cancer surgery(including re-excision of margins). Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s). Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator.

Variables de resultado

Variable de resultado principal
Time to invasive or noninvasive IBTR.
Time from randomization to any invasive or noninvasive IBTR or last follow-up (expressed as % IBTR-free)
Plazo 5 years
Variable de resultado secundaria
Percent of women with an intact index breast at report of the primary endpoint inclusive of salvage second breast conservation procedures.
Time from randomization to any breast procedure after the initial surgery or last follow-up (expressed as % with intact index breast)
Plazo Through study completion, an average of 15 years.
Variable de resultado secundaria
Time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence.
Time from randomization to any invasive IBTR or last follow-up (expressed as percentage of invasive IBTR-free
Plazo 5 years
Variable de resultado secundaria
Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event.
Time from randomization to any breast cancer recurrence at a local, regional or distant site or last follow-up (expressed as percentage of recurrence-free)
Plazo 5 years
Variable de resultado secundaria
Time from randomization to the first distant cancer event (either a recurrence or a secondary primary cancer).
Time from randomization to any cancer occurring at a distant site or last follow-up (expressed as percentage of distant disease-free)
Plazo 5 years
Variable de resultado secundaria
Time from randomization to any death.
Time from randomization to any death or last follow-up (expressed as percent surviving)
Plazo 5 years

Fechas

Fechas
Fecha de inicio	23 de junio de 2021 (real)
Finalización principal	8 de abril de 2031 (estimada)
Finalización	1 de julio de 2041 (estimada)
Primera publicación	21 de abril de 2021 (real)
Última actualización	23 de abril de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	abril de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

726 centros están en reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Kingston Health Sciences Centre	Kingston	Ontario	En reclutamiento
CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	En reclutamiento
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)	Québec	Quebec	En reclutamiento
Allan Blair Cancer Centre	Regina	Saskatchewan	En reclutamiento
Atlantic Health Sciences Corporation-Saint John Regional Hospital	Saint John	New Brunswick	En reclutamiento
Saskatoon Cancer Centre	Saskatoon	Saskatchewan	En reclutamiento
Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario	En reclutamiento

Hong Kong

Hong Kong
Centro	Ciudad	Estado o región	Estado
Pamela Youde Nethersole Eastern Hospital	Chai Wan		Suspendido

Japan

Japan
Centro	Ciudad	Estado o región	Estado
Hyogo Cancer Center	Akashi	Hyōgo	En reclutamiento
Gunma University Hospital	Gunma	Maebashi	En reclutamiento
Hiroshima University Hospital	Hiroshima		En reclutamiento
The Cancer Institute Hospital Of JFCR	Koto-ku	Tokyo	En reclutamiento
Kyoto University Hospital	Kyoto		En reclutamiento
Shikoku Cancer Center	Matsuyama		En reclutamiento
Nagoya University Hospital	Nagoya		En reclutamiento
Kindai University	Osaka		En reclutamiento
Saitama Medical University International Medical Center	Saitama		En reclutamiento
Hokkaido University Hospital	Sapporo	Hokkaido	En reclutamiento
National Cancer Center Hospital	Tokyo		En reclutamiento
Ehime University Hospital	Tōon	Ehime	En reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Hendrick Medical Center	Abilene	Texas	Activo, sin reclutar
Summa Health System - Akron Campus	Akron	Ohio	En reclutamiento
Cleveland Clinic Akron General	Akron	Ohio	En reclutamiento
Atrium Health Stanly/LCI-Albemarle	Albemarle	North Carolina	En reclutamiento
Mayo Clinic Health System in Albert Lea	Albert Lea	Minnesota	En reclutamiento
University of New Mexico Cancer Center	Albuquerque	New Mexico	En reclutamiento
Saint Luke's Cancer Center - Allentown	Allentown	Pennsylvania	Suspendido
Northside Hospital-Alpharetta	Alpharetta	Georgia	En reclutamiento
AdventHealth Altamonte	Altamonte Springs	Florida	En reclutamiento
Alton Memorial Hospital	Alton	Illinois	Activo, sin reclutar
American Fork Hospital / Huntsman Intermountain Cancer Center	American Fork	Utah	En reclutamiento
McFarland Clinic - Ames	Ames	Iowa	En reclutamiento
Mary Greeley Medical Center	Ames	Iowa	En reclutamiento
Kaiser Permanente-Anaheim	Anaheim	California	En reclutamiento
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	En reclutamiento
University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	En reclutamiento
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	En reclutamiento
Langlade Hospital and Cancer Center	Antigo	Wisconsin	En reclutamiento
Kaiser Permanente-Deer Valley Medical Center	Antioch	California	En reclutamiento
ThedaCare Regional Cancer Center	Appleton	Wisconsin	Activo, sin reclutar
Mission Hope Medical Oncology - Arroyo Grande	Arroyo Grande	California	En reclutamiento
PCR Oncology	Arroyo Grande	California	En reclutamiento
Mission Hospital	Asheville	North Carolina	En reclutamiento
Hope Women's Cancer Centers-Asheville	Asheville	North Carolina	En reclutamiento
Mount Sinai Queens	Astoria	New York	En reclutamiento
Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	En reclutamiento
Emory Saint Joseph's Hospital	Atlanta	Georgia	En reclutamiento
Grady Health System	Atlanta	Georgia	En reclutamiento
Emory University Hospital Midtown	Atlanta	Georgia	En reclutamiento
Piedmont Hospital	Atlanta	Georgia	En reclutamiento

En el registro figuran 782 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04852887