SCCA Clinical Studies: Phase 1 Program
|Closed||Advanced Breast Cancer||Phase I||NCT01104259|
RATIONALE: ABT-888 may stop the growth of some tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and vinorelbine ditartrate, work in different ways to stop the growth of tumor cells, either by killing them or stopping them from dividing. Giving ABT-888 together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of ABT-888 when given together with cisplatin and vinorelbine ditartrate in treating patients with recurrent and/or metastatic breast cancer.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Subjects with histologically confirmed (either primary or metastatic site) recurrent and/or metastatic breast cancer that is ER-negative, PR-negative, and HER2 non-overexpressing by IHC (0, 1) or non-amplified by FISH
- Subjects with histologically confirmed BRCA1 or BRCA2 deficient recurrent and/or metastatic breast cancer
- Subjects must have measurable disease, defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
- Subjects may have had any number of prior chemotherapy, endocrine therapy, immunologic, or biologic regimens for metastatic breast cancer
- Performance status >= 60% on the Karnofsky scale (ECOG =< 2)
- Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm^3 (1.5 x 10^9/L); Platelets >= 100,000/mm^3 (100 x 10^9/L); Hemoglobin >= 9.5 g/dL (1.4 mmol/L)
- Serum creatinine =< 1.5 x upper normal limit of institution's normal range OR creatinine clearance >= 50 mL/min/1.73m^2 for subjects with creatinine levels above institutional normal
- Hepatic function: AST and/or ALT =< 2.5 x the upper normal limit of institution's normal range; for subjects with liver metastases, AST and/or ALT < 5 x the upper normal limit of institution's normal range
- Bilirubin =< 1.5 x the upper normal limit of institution's normal range; subjects with Gilbert's Syndrome may have a bilirubin > 1.5 x the upper normal limit of institution's normal range
- PTT must be =< 1.5 x the upper normal limit of institution's normal range and INR < 1.5; subjects on anticoagulant (such as coumadin) will have PTT and INR as determined by the Investigator
- Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for 90 days following completion of therapy; women of childbearing potential must have a negative serum pregnancy test within 21 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential: 1) total abstinence from sexual intercourse (minimum one complete menstrual cycle); 2) vasectomized partner of female subjects; 3) hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; 4) double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream); 5) IUD (Intra-Uterine Device)
- Radiation therapy of a non-target lesion must have been completed at least 2 weeks prior to the enrollment date
- Subjects with previously treated brain metastases if stability documented on imaging within 28 days of enrollment
- Ability to understand and the willingness to sign a written informed consent document
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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