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Research & Trial Information

SCHEMA S1416

Protocol#:  SWOG – S1416

Cancer Type: Breast Metastatic Triple Negative

Eligibility:

  1. Patients must have metastatic breast cancer and be HER2 non-over expressing per 2013 ASCO-CAP HER testing guidelines (0 or 1+ by IHC; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by ISH).
  2. Patients must also meet at least one of the following criteria:
    1. Triple Negative: Histologically confirmed primary and/or metastatic site that is ER-negative (≤ 1%), PR-negative (≤ 1%), and HER2–negative.
    2. BRCA mutation: Previously confirmed deleterious BRCA1 or BRCA2
    3. germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification. Documentation of germline test results are required.
  3. Patients must have measurable or non-measurable disease, must have a chest/abdominal/pelvis CT scan (or PET/CT of diagnostic quality, conventional or spiral) and bone scan prior to registration. If the patient is unable to undergo CT with IV contrast due to allergy or renal insufficiency, a noncontrast CT may be performed.
  4. Patients must be women or men ≥ 18 years of age.
  5. Patients must have adequate tissue available, must agree to have specimens submitted for germline DNA sequencing and other correlative studies.
  6. Prior/Concurrent Therapy Criteria:
    1. Patients must have had ≤ 1 prior cytotoxic regimen for metastatic disease.
    2. Patients must have completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration.
    3. Patients must not have received prior cisplatin or PARP inhibitors. Prior carboplatin in the adjuvant/neoadjuvant setting is allowed, if completed more than 12 months prior to study entry.
    4. Patients must not have received any chemotherapy within 14 days prior to registration.
    5. Patients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration. Patients must not have received bevacizumab within 42 days prior to registration.
    6. Patients may receive bisphosphonates or denosumab concurrently with study treatment provided it has been started at least 7 days prior to registration.
    7. Patients must have recovered to ≤ Grade 2 following a significant adverse event or toxicity attributed to previous anti-cancer treatment except neurotoxicity which must be ≤ Grade 1.
  7. Patients must have a performance status of 0-2 by Zubrod.
  8. Patients must have adequate bone marrow function, as defined by Absolute Neutrophil Count (ANC) of >/= 1,500/mcL, hemoglobin >/= 9 g/dL and a platelet count >/= 100,000/ mcL.
  9. Patients must have adequate hepatic function.
  10. Patients must have adequate renal function with serum creatinine level ≤ IULN.
  11. Patients must have serum chemistries (including potassium and magnesium)
  12. Patients must not have a clinically relevant hearing impairment ≥ Grade 2.
  13. Patients must be able to swallow whole capsules.
  14. Patients with a history of uncontrolled seizure disorder; including focal or generalized seizure may not have had a seizure within one year prior to registration.
  15. Patients with known brain metastases must either meet the additional criteria in Section 5.5 and enroll as part of the Brain Metastases Cohort, or else have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 14 days of stable neurologic function prior to registration. Patients with previously treated progressive brain metastases are not eligible for the Standard Cohort, but may be considered for the Brain Metastases Cohort (see Section 5.5).
  16. Patients must not have any incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) that would limit the patient’s ability to participate in the protocol.
  17.  Patients must not have baseline peripheral neuropathy that exceeds Grade 1.
  18. Patients must have a complete history and physical examination.
  19. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
  20. Brain Metastases Cohort In addition to all of the previous eligibility criteria, patients with progressive brain metastases who do not satisfy the conditions in Section 5.3h to enroll in the Standard Cohort (neurologic stability for 14 days following surgery and/or radiation therapy) must also meet the following criteria to enroll as part of the Brain Metastases Cohort:
    1. Patients with progressive brain metastases must have a baseline brain MRI within 28 days prior to registration. Brain metastases must be progressive and ≥ 10 mm in longest dimension on radiographic imaging AFTER prior intracranial radiation (IR) therapy (i.e., WBRT, SRS, GK or local equivalent). Patients must not have evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology. Discrete dural metastases are permitted. There must be no evidence of hemorrhage or impending herniation on baseline brain imaging. Patients with contraindication to gadolinium-enhanced MRI imaging are not eligible.
    2. Patients must be on a stable or decreasing dose of steroids for ≥ 7 days prior to registration.
    3. If patient has had an open brain biopsy, at least 28 days must have elapsed between biopsy and registration.

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