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

Breast Cancer Clinical Trial

Official title: A Phase II Study of BIBF1120 (Nintedanib) for Patients With Metastatic HER2-Negative Inflammatory Breast Cancer (IBC)

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Study Drug Administration:

Each study cycle is 4 weeks.

If you are found to be eligible to take part in this study, you will take nintedanib capsules by mouth 2 times each day. Each dose should be about 12 hours apart, at about the same times every day. The capsules should be swallowed whole with about a cup (8 ounces) of water within 30 minutes after eating a meal.

If you forget to take the capsules and it has been more than 2 hours since you were scheduled to take the dose, you should skip that dose and take the next dose as scheduled. Do not double the next dose to "make up" the missed one.

You will be given a study drug diary to write down when you took each dose of study drug. You will need to bring back any empty or partially used bottles of study drug, along with any leftover study drug, with you to the clinic at each cycle.

If you experience side effects, you will be given standard drugs to help decrease the symptoms of the side effects. You may ask the study staff for information about how the drugs are given and their risks.

Study Visits:

All tests and procedures below will be performed before your dose of study drug.

On Day 1 of every cycle:

• You will have a physical exam.

• Blood (about 2 tablespoons) will be drawn for routine tests.

On Day 1 of Cycles 1-7 and then every odd-numbered cycle after that (Cycles 9,11, 13, and so on), the physical exam and blood draw will be performed at MD Anderson . On Day 1 of Cycles 8 and then every even-numbered cycle after that (Cycles 10, 12, 14, and so on), the physical exam and blood draw may be performed at a local clinic or doctor's office and the results will be sent to the study doctor for review. The study doctor will discuss this option with you.

On Day 1 of Cycle 3, blood (about 2 tablespoons) will also be drawn for biomarker testing.

On Day 1 of Cycles 3, 5, 7, and then every odd numbered cycle after that (Cycles 9, 11, 13, and so on):

• If the doctor thinks it is needed, photographs will be taken of any areas affected by the disease.

• If the doctor thinks it is needed, you will have an x-ray, ultrasound, CT scan, PET/CT scan, and/or a bone scan to check the status of the disease.

At any point that the doctor thinks it is needed, you will have an EKG, ECHO, and/or MUGA scan. You may have any of the above tests/procedures repeated as well, if the doctor thinks it is needed, to check on your health.

Length of Study:

You may continue taking the study drug for up to 2 years. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after you have completed the follow-up period.

End-of-Treatment Visit:

Within 14 days after the last study visit:

• You will have a physical exam.

• Blood (about 1 tablespoon) will be drawn for routine tests.

• If the doctor thinks it is needed, photographs will be taken of your skin and any areas affected by the disease.

• If the doctor thinks it is needed, you will have an x-ray, ultrasound, CT scan, PET/CT scan, and/or a bone scan to check the status of the disease.

• If the doctor thinks it is needed, you will have an EKG and either an ECHO or MUGA scan.

Follow-up Visits:

You will be called by a member of the study staff every 3 months for up to 1 year after your end-of-treatment visit and asked how you are doing. These calls should last about 2 minutes. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02389764
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: June 22, 2015
• Completion date: June 8, 2019