Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC) (NCT02389764) | Clinical Trial Compass
TerminatedPhase 2
Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)
Stopped: Slow Accrual
United States10 participantsStarted 2015-06-22
Plain-language summary
The goal of this clinical research study is to learn if Ofev® (nintedanib, also called BIBF1120) can help to control IBC. The safety of this drug will also be studied.
This is an investigational study. Nintedanib is commercially available and FDA approved for the treatment of certain types of lung disease. Its use in this study is investigational. The study doctor can explain how the study drug is designed to work.
Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients are 18 years of age or older
✓. Patients are female or male.
✓. 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 at diagnosis.
✓. Have confirmed distant metastasis with or without local recurrence.
✓. Have negative HER2 expression by IHC (defined as 0 or1+), or FISH. If HER2 is 2+, negative HER2 expression must be confirmed by FISH.
✓. Patients may undergo an optional biopsy of the metastatic disease at baseline and after 2 cycles of BIBF-1120.
✓. Estimated life expectancy of at least 3 months
✓. Have ECOG performance status score 0-2
Exclusion criteria
What they're measuring
1
Clinical Benefit Rate (Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Date) of BIBF 1120 (Nintedanib) in Patients With HER2-negative Metastatic Inflammatory Breast Cancer (IBC).
. Patients have an active infection and require IV or oral antibiotics.
✕. Patients have 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) LVEF assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) \< 45%; d). pericardial effusion
✕. 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) \> NYHA II, Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE),
✕. Uncontrolled hypertension defined by an SBP\>150 and/or a 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 as determined by the investigator.
✕. 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 as determined by the investigator.
✕. Patients with only locally or regionally confined disease without evidence of metastatic disease
✕. Prior treatment with BIBF 1120 or any other VEGFR inhibitor within 4 weeks