18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).Primary· 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 n
Group
Value
95% CI
BIBF 1120
9
BIBF 1120
0
BIBF 1120
0
BIBF 1120
0
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.Secondary· 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)
Grade 3-hematological toxicity
Group
Value
95% CI
BIBF 1120
0
Grade 4-hematological toxicity
Group
Value
95% CI
BIBF 1120
0
Grade 2-non-hematological toxicity
Group
Value
95% CI
BIBF 1120
9
Grade 3-non-hematological toxicity
Group
Value
95% CI
BIBF 1120
4
Grade 4-non-hematological toxicity
Group
Value
95% CI
BIBF 1120
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event collection was from a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to 24 months and/or up to 30 days following discontinuation of study drug..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BIBF 1120
Serious: 1/9 (11%)
Deaths: 1/9
Serious adverse events (2 terms)
Reaction
System
BIBF 1120
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Other adverse events (22 terms — click to expand)
Reaction
System
BIBF 1120
Vomiting
Gastrointestinal disorders
—
Diarrhea
Gastrointestinal disorders
—
Fatigue
General disorders
—
Nausea
Gastrointestinal disorders
—
Abdominal pain
Gastrointestinal disorders
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01346540 — A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First
· Phase 1
· completed
NCT01170065 — Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
· Phase 2
· completed
NCT01024920 — Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
· Phase 2
· completed
NCT01015118 — LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of
· Phase 3
· completed
NCT01004003 — Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcino
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 17 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02389764.