April 8, 2020 Breast Adjuvant

Clinical Trial Information

PROTOCOL: NRG-BR003

SCHEMA NRG BR003

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. The trial is open to female and male patients. Age ≥ 18 years.
  2. ECOG Performance Status of 0 or 1.
  3. The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  4. All of the following staging criteria must be met:
    1.   By pathologic evaluation, primary tumor must be pT1-3
    2. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c),
      pN2a, pN2b, pN3a, or pN3b.
    3. If pN0, pathological tumor must be ≥ 3.0 cm.
  5. The tumor must have been determined to be HER2-negative as follows.
  6. The tumor must have ER and PgR status assessed.
  7. The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy.
  8. For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS 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. If tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
  9. For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible as long as post-mastectomy RT of the chest wall will be administered.)
  10. The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.
    1. Sentinel lymphadenectomy alone:
      − If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;
      − If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the
      patient has undergone breast conserving surgery (with planned breast radiotherapy), the
      primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must
      be limited to 1 or 2 positive nodes.
    2. Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
    3. Axillary lymphadenectomy with or without SN isolation procedure.
  11. The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days.
  12.  No T4 tumors including inflammatory breast cancer.
  13. No synchronous or previous contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
  14. No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
  15.  No 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 randomization.
  16.  No previous therapy with anthracyclines or taxanes for any malignancy.
  17. No chemotherapy administered for the currently diagnosed breast cancer prior to randomization.


April 8, 2020 Breast Adjuvant

Clinical Trial Information

PROTOCOL: ECOG-EA1131

SCHEMA EA1131

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Age ≥ 18 years.
  2. ECOG Performance Status 0 or 1 within 2 weeks prior to screening.
  3. Female and male patients must have histologically confirmed invasive breast cancer.
    1. Clinical stage II or III at diagnosis, based
      on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed.
    2. ER- and PR- should meet one of the following criteria:
      ≤ 10% cells stain positive, with weak intensity score
      ≤ 1% cells stain positive.
    3. HER2 negative (not eligible for anti-HER2 therapy) will be
      defined as:
      IHC 0, 1+ without ISH HER2/neu chromosome 17 ratio OR
      IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells OR
      ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells without IHC)
  4. Patients must have completed neoadjuvant taxane +/- anthracycline. Patients must NOT have received cisplatin or carboplatin or
    capecitabine as part of their neoadjuvant therapy regimen.
  5. Must have completed definitive resection of primary tumor.
  6. Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery.
  7. Radiotherapy may be given before or after protocol treatment per standard of care guidelines. When radiotherapy is planned prior to
    protocol treatment administration, patients may be registered and screened while receiving radiation.
  8. No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort.
  9. Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed. LHRH agonists and adjuvant bisphosphonate or denosumab use is allowed.

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