NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

SWOG S1416 - "PHASE II RANDOMIZED PLACEBO-CONTROLLED TRIAL OF CISPLATIN WITH OR WITHOUT ABT-888 (VELIPARIB) IN METASTATIC TRIPLE-NEGATIVE BREAST CANCER AND/OR BRCA MUTATION-ASSOCIATED BREAST CANCER"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Breast Clinical Trial

CANCER TYPE: Stage IV
RESEARCH BASE: SWOG
NCT NUMBER: NCT02595905
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Breast, stage IV, triple negative and/or BRCA positive, cisplatin +/- ABT-888 (Veliparib)



NOTES


Only the brain mets cohort is open to enrollment.

Treatment   (Supplied Drug:  ABT-888 (Veliparib)/placebo)

Arm 1:

Cisplatin 75mg/m2, IV, day 1

Placebo, BID, days 1-14

Arm 2:

Cisplatin 75mg/m2, IV, day 1

ABT-888 300mg, PO, BID, days 1-14

Cycle = 21 days



ELIGIBILITY

  • 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).
  • Patients must also meet at least one of the following criteria:
    • Triple Negative: Histologically confirmed primary and/or metastatic site that is ER-negative (≤ 1%), PR-negative (≤ 1%), and HER2–negative.
    • BRCA mutation: Previously confirmed deleterious BRCA1 or BRCA2 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.
  • Patients must have measurable or non-measurable disease (see Section 10.1). Patients 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 non-contrast CT may be performed. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form.
  • Patients must be women or men ≥ 18 years of age.
  • Patients must have adequate tissue available, must agree to have specimens submitted for germline DNA sequencing and other correlative studies and must submit as per Sections 15.1, 15.2, 15.3 and 15.4.
  • Patients must have had ≤ 1 prior cytotoxic regimen for metastatic disease.
  • Patients must have completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration.
  • 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.
  • Patients must not have received any chemotherapy within 14 days prior to registration.
  • 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.
  • Patients may receive bisphosphonates or denosumab concurrently with study treatment provided it has been started at least 7 days prior to registration.
  • 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.
  • Patients must have a performance status of 0-2 by Zubrod criteria (see Section 10.4)
  • 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 within 21 days prior to registration.
  • Patients must have adequate hepatic function obtained within 21 days prior to registration and documented by all of the following:
    • Bilirubin ≤ 1.5 mg/dL (or ≤ 3.0 mg/dL if due to Gilbert's Syndrome or if liver metastases are present)
    • ALT and AST ≤ 2.5 x Institutional Upper Limit of Normal (IULN) (or ≤ 5 x IULN if liver metastases are present)
  • Patients must have adequate renal function with serum creatinine level ≤ IULN within 21 days prior to registration.
  • Patients must have serum chemistries (including potassium and magnesium) done within 21 days prior to registration to obtain baseline values.
  • Patients must not have a clinically relevant hearing impairment ≥ Grade 2.
  • Patients must be able to swallow whole capsules.
  • 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.
  • 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).
  • 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.
  • Patients must not have baseline peripheral neuropathy that exceeds Grade 1.
  • Patients must have a complete history and physical examination within 28 days prior to registration.
  • Patients of childbearing potential must not be pregnant (negative pregnancy test) or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen. Men and women of reproductive potential must have agreed to use an effective contraceptive method for 6 months after completion of study treatment.
  • 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.
  • 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:
    • 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.
    • Patients must be on a stable or decreasing dose of steroids for ≥ 7 days prior to registration.
    • If patient has had an open brain biopsy, at least 28 days must have elapsed between biopsy and registration.





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