Trial Outcomes & Findings for Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC) (NCT NCT02389764)
NCT ID: NCT02389764
Last Updated: 2019-07-17
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
2 years
Results posted on
2019-07-17
Participant Flow
One participant was registered twice in error.
Participant milestones
| Measure |
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.
BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.
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.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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.
BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.
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.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
9
|
Baseline Characteristics
Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC)
Baseline characteristics by cohort
| Measure |
BIBF 1120
n=9 Participants
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.
BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsClinical 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.
Outcome measures
| Measure |
BIBF 1120
n=9 Participants
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.
BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.
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 (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).
Progressive Disease
|
9 Participants
|
|
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).
Complete Response
|
0 Participants
|
|
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).
Partial Response
|
0 Participants
|
|
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).
Stable Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsAn 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)
Outcome measures
| Measure |
BIBF 1120
n=9 Participants
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.
BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.
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.
|
|---|---|
|
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.
Grade 3-non-hematological toxicity
|
4 participants
|
|
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.
Grade 4-non-hematological toxicity
|
0 participants
|
|
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.
Grade 3-hematological toxicity
|
0 participants
|
|
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.
Grade 4-hematological toxicity
|
0 participants
|
|
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.
Grade 2-non-hematological toxicity
|
9 participants
|
Adverse Events
BIBF 1120
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BIBF 1120
n=9 participants at risk
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.
BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • 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.
|
Other adverse events
| Measure |
BIBF 1120
n=9 participants at risk
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.
BIBF 1120: Initial dose is 200 mg twice daily orally for a 28 day cycle.
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.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • 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.
|
|
General disorders
Fatigue
|
44.4%
4/9 • 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.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
22.2%
2/9 • 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.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
22.2%
2/9 • 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.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • 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.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.1%
1/9 • 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.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • 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.
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • 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.
|
|
Investigations
Weight loss
|
11.1%
1/9 • 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.
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • 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.
|
|
Infections and infestations
Shingles
|
11.1%
1/9 • 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.
|
|
General disorders
Edema limbs
|
11.1%
1/9 • 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.
|
|
Vascular disorders
Hot flashes
|
11.1%
1/9 • 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.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
11.1%
1/9 • 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.
|
Additional Information
Ueno,Naoto,M.D., PH.D. / Breast Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-2817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place