CompletedPhase 2

TKI258 for Metastatic Inflammatory Breast Cancer Patients

United States22 participantsStarted 2012-01-27

Plain-language summary

The goal of this clinical research study is to learn if dovitinib can help to control inflammatory breast cancer. The safety of this drug will also be studied.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Patients have histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
✓. Patients have stage IV disease with local or distant relapse
✓. Patients have negative HER2 expression by IHC (defined as 0 or1+), or fluorescence in situ hybridization (FISH). If HER2 is 2+, negative HER2 expression must be confirmed by FISH.
✓. Patients are able to swallow and retain oral medication.
✓. Patients have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
✓. Patients have received two or more standard chemotherapies for metastatic disease and have relapsed.
✓. Patients have ability and willingness to sign written informed consent.
✓. Patients are 18 years of age or older.

Exclusion criteria

✕. Patients are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiation therapy and biological therapy) while taking study medication.
✕. Cirrhosis of liver, or known hepatitis B or C infection have hepatic impairment Child-Pugh Score of B or worse.
✕. Absolute neutrophil count (ANC) \< 1.5
✕. Patients have an active infection and require IV or oral antibiotics.
✕. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: a) History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation; b) Clinically significant resting bradycardia (\< 50 beats per minute); c) left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) \< 50% or lower limit of normal (which ever is higher) or multiple gated acquisition scan (MUGA) \< 45% or lower limit of normal (which ever is higher). d) Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE); e) Uncontrolled hypertension defined by an SBP\>150 and/or a diastolic blood pressure (DBP)\>100 mm Hg with or without anti-hypertensive medication.
✕. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.
✕. Patients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients safety.
✕. Patients with only locally or regionally confined disease without evidence of metastatic disease.

What they're measuring

Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants

Timeframe: 6 months

Trial details

NCT IDNCT01262027

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11-25

Results submitted2016-12-08

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