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

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ClinicalTrials.gov Identifier: NCT02389764
Recruitment Status : Terminated (Slow Accrual)
First Posted : March 17, 2015
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Boehringer Ingelheim
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: BIBF 1120 Behavioral: Phone Call Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of BIBF1120 (Nintedanib) for Patients With Metastatic HER2-Negative Inflammatory Breast Cancer (IBC)
Actual Study Start Date : June 22, 2015
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2019

Arm Intervention/treatment
Experimental: BIBF 1120
Initial dose of BIBF 1120 is 200 mg twice daily orally for a 28 day cycle. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit.
Drug: BIBF 1120
Initial dose is 200 mg twice daily orally for a 28 day cycle.
Other Name: Nintedanib

Behavioral: Phone Call
Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. These calls should last about 2 minutes.

Primary Outcome Measures :
  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). [ Time Frame: 2 years ]
    Clinical benefit defined as participants who achieve CR or PR within 3 months post-treatment, or participants who experience SD for at least three months post-treatment. Clinical benefit rate determined by RECIST 1.1 version." PATHOLOGICAL CR: No evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes. PR is defined as 30% or greater decrease for a minimum of 4 weeks in the measurable lesion as determined by the product of the perpendicular diameters of the lesion. Every lesion should not regress to qualify as a PR. However, if any lesion progresses or if new lesions appear, the response cannot be classified as a (PR). Minor Response [MR] Decreases in tumor masses insufficient to qualify as a partial remission, i.e. <50%. SD between MR and PD. PD increase in the size by 25% of any measured lesion from baseline. Appearance of new lesions will also constitute increasing disease. Mixed responses will be considered PD.

Secondary Outcome Measures :
  1. Safety Measures of BIBF 1120 in Terms of Type, Frequency and Severity of Adverse Event According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in Patients With Metastatic IBC. [ Time Frame: 2 years ]
    An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All adverse events (grade 3 or higher for hematological toxicity, grade 2 or higher for non-hematological toxicity)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients are 18 years of age or older
  2. Patients are female or male.
  3. 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.
  4. Have confirmed distant metastasis with or without local recurrence.
  5. Have negative HER2 expression by IHC (defined as 0 or1+), or FISH. If HER2 is 2+, negative HER2 expression must be confirmed by FISH.
  6. Patients may undergo an optional biopsy of the metastatic disease at baseline and after 2 cycles of BIBF-1120.
  7. Estimated life expectancy of at least 3 months
  8. Have ECOG performance status score 0-2
  9. Have received at least one any prior treatment for local recurrence or metastatic disease and have relapsed.
  10. Signed and dated written informed consent prior to admission to the study
  11. If Patients have been treated with anti-VEGF agents, such as Bevacizumab, last dose must be >/= 4 weeks.
  12. Have tissues from a biopsy, or have up to 20 unstained slides available from archived metastatic tissue block for biomarker evaluation
  13. Patients are able to swallow and retain oral medication

Exclusion Criteria:

  1. Patients have an active infection and require IV or oral antibiotics.
  2. 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
  3. 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),
  4. Uncontrolled hypertension defined by an SBP>150 and/or a DBP>100 mm Hg with or without anti-hypertensive medication
  5. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug as determined by the investigator.
  6. 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.
  7. Patients with only locally or regionally confined disease without evidence of metastatic disease
  8. Prior treatment with BIBF 1120 or any other VEGFR inhibitor within 4 weeks
  9. Known hypersensitivity to the trial drugs , to their excipients or to contrast media
  10. 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
  11. Persistence of toxicity from previous chemo and/or radiotherapy > grade 2.
  12. 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).
  13. Radiographic evidence of cavitary or necrotic tumors
  14. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
  15. 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
  16. 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
  17. 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
  18. History of clinically significant haemorrhagic or thromboembolic event in the past 6 months
  19. Known inherited predisposition to bleeding or thrombosis
  20. Proteinuria CTCAE grade 2 or greater
  21. Creatinine >/= 1.5 x ULN or GFR < 45 ml/min
  22. 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
  23. Coagulation parameters: International normalised ratio ( INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
  24. Absolute neutrophil count ( ANC) < 1500/ml, platelets < 100000/ml, Haemoglobin < 9.0 g/dl
  25. Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix
  26. Known history of active or chronic hepatitis C and/or B infection
  27. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
  28. Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females) during the trial and for at least three months after end of active therapy (Contraception in patients with preserved reproductive capacity, patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.)
  29. Patients with child bearing potential must have a negative pregnancy test (urine or serum) prior to study treatment
  30. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
  31. Active alcohol or drug abuse
  32. Significant weight loss (> 10% of BW) within past 6 months prior to inclusion into the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389764

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Boehringer Ingelheim
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Principal Investigator: Naoto Ueno, MD, PHD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02389764    
Other Study ID Numbers: 2014-0464
NCI-2015-00506 ( Other Identifier: NCI CTRP )
First Posted: March 17, 2015    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Breast cancer
Metastatic inflammatory breast cancer
Breast carcinoma
BIBF 1120
Phone call
Additional relevant MeSH terms:
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Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action