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

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Trial ID: NCT04852887

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.

Official Title

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

Stanford Investigator(s)

Irene Wapnir, MD
Irene Wapnir, MD

Professor of Surgery (General Surgery)

Eligibility


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.

Intervention(s):

other: Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shreya Perepa
650-736-2952

Stanford Cancer Center South Bay
2589 Samaritan Drive
San Jose, CA 95124
Justin Casey

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