RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether skipping breast radiation after a lumpectomy works as well as having radiation to keep cancer from coming back in the same breast. Both groups take hormone-blocking medicine. It is for people with small breast cancers that respond to hormones, are HER2-negative, and have a low score on a tumor test.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal representative must agree to join. You must be fully active or able to do light work.
  • You must have invasive breast cancer in one breast only. The tumor must be 2 cm or smaller.
  • You must have had a lumpectomy, surgery to remove the tumor. The edges of the removed tissue must be free of invasive cancer and DCIS, an early form of breast cancer.
  • Lymph nodes under your arm must have been checked and found free of cancer, including tiny amounts found by special tests.
  • Your Oncotype DX score must be 18 or lower. An existing MammaPrint result marked “Low” may also qualify. These tests help estimate the risk of cancer returning.
  • The cancer must respond to estrogen or progesterone and be HER2-negative, meaning it does not have high levels of the HER2 protein.
  • Your last breast cancer surgery must be within 70 days before the first enrollment step. Your wound must be fully healed without infection. Both breasts must have been checked by mammogram or MRI within 6 months.
  • You must plan to take hormone-blocking medicine for at least 5 years. People before or after menopause may join.

Who can't join

  • Cancer has spread beyond the breast, is in lymph nodes, is larger than 2 cm, or is classed as microinvasive, meaning only a very tiny area has grown beyond its starting point. Inflammatory breast cancer is also excluded.
  • You had a mastectomy, surgery to remove the breast, or the edges of removed tissue still contain cancer or cannot be checked.
  • You have suspicious breast or lymph node findings that have not been shown to be harmless by a biopsy.
  • You have cancer in separate breast areas more than one quarter of the breast apart or at least 4 cm apart; Paget’s disease of the nipple; or breast sarcoma or lymphoma.
  • You have another current or past invasive breast cancer or DCIS. Most other cancers within the past 5 years also exclude you, with exceptions for certain early cancers and skin cancers.
  • You have had breast or chest radiation before, already had radiation, chemotherapy, or biological treatment for this cancer, or plan radiation to nearby lymph nodes.
  • You take hormone medicine for bone health or cancer prevention, or plan to keep using estrogen replacement. Hormone treatment for this cancer has special rules; some short treatment before surgery and treatment after surgery are allowed.
  • You are pregnant, breastfeeding, or plan pregnancy during treatment; have certain active immune diseases, such as lupus or scleroderma; or have another condition that makes treatment unsafe or prevents you from meeting study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (812)

AL

AR

AZ

CA

CO

CT

DC

DE

FL

GA

HI

IA

ID

IL

IN

KS

KY

LA

MA

MD

ME

  • Lafayette Family Cancer Center-EMMC · Brewer, ME 04412Site Public Contact · Study contact · 800-987-3005Sarah J. Sinclair · Principal investigatorMore trials in Brewer

MI

MN

MO

MS

MT

NC

ND

NE

NH

NJ

NM

NV

NY

OH

OK

OR

PA

RI

SC

SD

TN

  • University of Tennessee - Knoxville · Knoxville, TN 37920Site Public Contact · Study contact · 865-544-9773Sarah Jenkins · Principal investigatorMore trials in Knoxville
  • The Children's Hospital at TriStar Centennial · Nashville, TN 37203Site Public Contact · Study contact · 615-342-1919Andrew S. Kennedy · Principal investigatorMore trials in Nashville
  • Vanderbilt Breast Center at One Hundred Oaks · Nashville, TN 37204Site Public Contact · Study contact · 800-811-8480Anuradha B. Chakravarthy · Principal investigatorMore trials in Nashville
  • Vanderbilt University/Ingram Cancer Center · Nashville, TN 37232Site Public Contact · Study contact · 800-811-8480Anuradha B. Chakravarthy · Principal investigatorMore trials in Nashville

TX

UT

VA

VT

WA

WI

WV