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

NCT02389764 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2014-0464NCI-2015-00506
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Metastatic inflammatory breast cancer; MIBC; HER2-negative; Breast carcinoma; BIBF 1120; Nintedanib; Phone call

Outcome Measures

Primary Outcomes (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).

  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.

  2 years

Secondary Outcomes (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.

  2 years

Study Arms (1)

BIBF 1120

EXPERIMENTAL

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; Behavioral: Phone Call

Interventions

BIBF 1120 DRUG

Initial dose is 200 mg twice daily orally for a 28 day cycle.

Also known as: Nintedanib

BIBF 1120

Phone Call BEHAVIORAL

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.

BIBF 1120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Ueno,Naoto,M.D., PH.D. / Breast Medical Oncology
• Organization: UT MD Anderson Cancer Center

nueno@mdanderson.org

713-792-2817

Study Officials

• Naoto Ueno, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: June 22, 2015
• Primary Completion: June 8, 2018
• Study Completion: June 8, 2019
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-06

Locations

US (1)