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Phase II Trial of Single Agent ABT-888 with Post-Progression Therapy of ABT-888 in Combination with Carboplatin in Patients with Stage IV BRCA-Associated Breast Cancer.
Open to Accrual
Defintions of terms and FAQ about clinical trials.
Agustin Garcia, M.D.
Other Trial Staff:
Kristy Watkins, R.N., Nancy Perez, R.N., Yvonne Flores, D.M., Anayansi Miloud, D.M.
to see study documents.
You may participate in this study if:
Patients must be female, and must have histologically confirmed breast cancer that is metastatic or locally advanced, unresectable and for which standard curative measures do not exist or are no longer effective.
Patients must have a known deleterious BRCA mutation confirmed by report from a CLIA certified laboratory (generally Myriad Genetics Laboratory). It is expected that BRCA testing will be covered as medically necessary care by the patient’s insurance carrier.
Measurable disease by RECIST criteria. (Evaluable disease is allowed only for the Safety Lead-In phase).
Prior chemotherapy regimens for metastatic disease are completed, at least 3 weeks prior to starting therapy.
Female, 18 years or older. Because no dosing or adverse event data are currently available on the use of ABT-888 in patients <18 years of age, children are excluded from this study.
ECOG Performance Status 0-2
Life expectancy of greater than four months.
Patients must have normal organ and marrow function as defined below - absolute neutrophil count greater than or equal to 1,500 - platelets greater than or equal to 100,000 - total bilirubin less than or equal to 1.5 X institutional upper limit of normal - AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal unless there is evidence of liver metastasis, in which case the AST(SGOT)/ALT(SGPT) must be less than or equal to 5 X institutional upper limit of normal - creatinine within normal institutional limits OR - creatinine clearance greater than or equal to 60 for patients with creatinine levels above institutional normal.
If a woman is of child-bearing potential, a negative serum or urine pregnancy test is required. (The effects of ABT-888 [NSC 737664] on the developing human fetus are unknown. For this reason and because PARP Inhibitor agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Participants should agree to use contraception for at least 3 months after the completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.)
Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
You may not participate in this study if:
Prior therapy with platinum agents (adjuvant therapy with platinum agents is allowed, if completed greater than or equal to 12 months prior to relapse), or PARP inhibitors.
Patients may not be receiving any other investigational agents
Patients with known CNS metastases with active symptomatology, or requiring anticonvulsive medications, or steroids.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 (NSC 737664) or PARP Inhibitors.
Patients with contraindications to platinum agents are excluded.
Prior or current non-breast malignancy within 5 years except non-melanoma skin cancer, or resected stage I ovarian cancer
Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the patient on protocol.
Pregnant women are excluded from this study because ABT-888 (NSC 737664) has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ABT-888 (NSC 737664), breastfeeding should be discontinued.
Patients unable to swallow the ABT-888 tablets whole are ineligible. (The tablets cannot be crushed or broken.)
Patients with an active severe infection; known infection with HIV, hepatitis B virus, or hepatitis C virus. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ABT-888 (NSC 737664). In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.