Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02389764

Run by

M.D. Anderson Cancer Center

People needed

10

Starts

2015-06-22

Expected to finish

2019-06-08

Last updated by the study team

2019-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Have received at least one any prior treatment for local recurrence or metastatic disease and have relapsed.
• Signed and dated written informed consent prior to admission to the study
• If Patients have been treated with anti-VEGF agents, such as Bevacizumab, last dose must be >/= 4 weeks.
• Have tissues from a biopsy, or have up to 20 unstained slides available from archived metastatic tissue block for biomarker evaluation
• Patients are able to swallow and retain oral medication

You may not qualify if…

• 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
• Known hypersensitivity to the trial drugs , to their excipients or to contrast media
• Chemotherapy, hormonal therapy, radiotherapy (except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug
• Persistence of toxicity from previous chemo and/or radiotherapy > grade 2.
• Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation).
• Radiographic evidence of cavitary or necrotic tumors
• Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
• Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
• Therapeutic anticoagulation( except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325mg per day
• Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
• History of clinically significant haemorrhagic or thromboembolic event in the past 6 months
• Known inherited predisposition to bleeding or thrombosis
• Proteinuria CTCAE grade 2 or greater
• Creatinine >/= 1.5 x ULN or GFR < 45 ml/min
• Hepatic function: total bilirubin outside of normal limits; ALT or AST >1.5 x ULN in pts without liver metastasis. For Pts with liver metastasis: total bilirubin outside of normal limits, ALT or AST >2.5 x ULN
• Coagulation parameters: International normalised ratio ( INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
• Absolute neutrophil count ( ANC) < 1500/ml, platelets < 100000/ml, Haemoglobin < 9.0 g/dl
• Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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