Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)
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|ClinicalTrials.gov Identifier: NCT02389764|
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : March 21, 2018
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of BIBF1120 (Nintedanib) for Patients With Metastatic HER2-Negative Inflammatory Breast Cancer (IBC)|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
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.
- Clinical Benefit Rate (CBR) of BIBF-1120 in Metastatic Inflammatory Breast Cancer (IBC) [ Time Frame: 2 years and 3 months ]Clinical benefit defined as participants who achieve complete response or partial response within 3 months post-treatment, or participants who experience stable disease for at least three months post-treatment. Clinical benefit rate determined by RECIST.
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
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PHD||M.D. Anderson Cancer Center|