SWOG clinical trial number
S0622

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer

Closed
Phase
Accrual
100%
Published
Abbreviated Title
ADVANCED: Phase II Dasatinib Treatment for Bone-Metastasis Predominant MBC
Activated
03/15/2007
Closed
12/15/2010
Participants
NCORP, Members, Medical Oncologists, Affiliates

Research committees

Breast Cancer

Treatment

Dasatinib

Eligibility Criteria Expand/Collapse

--Women/men with Stage IV breast carcinoma that is bone-predominant.
--May have had 0 or 1 prior chemotherapy regimens for metastatic disease.
--Patients who are ER+ and/or PgR+ must have progressed on at least one hormonal therapy in the metastatic setting.
--Must have measurable disease by RECIST criteria or non-measurable disease. If non-measurable, CA15-3, CA27-29, CEA, or CA-125 must be greater than the institution's upper limit of normal and there must be documentation of at least a 20% increase over the earlier measurement in the marker value prior to registration.
--EKG w/ QTc < 450 ms.
--Must consent to the serum and whole blood specimen submission (leftover serum for specimen banking is encouraged, but not required).
--Must complete Brief Pain Inventory w/in 14 days of registration and prior to the beginning of treatment (if consent is obtained).
--PS=0-2;
--Age >= 18.
--Must not have had prior therapy for RankL inhibitors.
--Must not have an inability to take oral medication.
--Must not have active brain or CNS metastasis (may have previously treated brain or CNS metastasis w/ radiation completed at least 8 wks prior to registration).
--Must not be receiving concurrent treatment for BC during this study (i.e. radiation, chemotherapy, immunotherapy, biological therapy, hormonal therapy, or gene therapy) except HER2+ patients taking trastuzumab for >=12 wks.
--Patients taking bisphophonates must stop at least 3 wks prior to registration.
--Must not have active infection requiring systemic therapy.
--Must not have significant cardiac disease or MI w/in 12 months.
--Must not have pleural or pericardial effusion prior to registration; must not require full dose anticoagulation w/ warfarin or heparins.
--Must not be receiving concurrent treatment w/ aspirin or other anti-platelet agents; treatment w/ CYP3A4 inhibitors must stop >= 7 days prior to registration.
--Must not be receiving concurrent treatment w/ meds that prolong the QT interval.
--No concurrent active malignancy is allowed. Prior malignancies are acceptable if the patient is currently disease-free.
--Must not be pregnant or nursing.
--Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

Publication Information Expand/Collapse

2016

Phase II studies of two different schedules of dasatinib in bone-metastasis predominant metastatic breast cancer: SWOG S0622

A Schott;W Barlow;C Van Poznak;D Hayes;C Moinpour;D Lew;C Reynolds;P Dy;E Keller;J Keller;G Hortobagyi Breast Cancer Research and Treatment Aug;159(1):87-95; 2016 Jul 30 [Epub ahead of print]

PMid: PMID27475087 | PMC number: PMC5021222