Trial · NCT01325428
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
NCT01325428, Phase 2, Completed, Boehringer Ingelheim; results first posted 2016-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer. Trials, record NCT01325428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01325428
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
- NCT number
- NCT01325428
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Breast Neoplasms
- Interventions
- Afatinib once daily (OD), Vinorelbine Weekly
- First posted
- 2011-03-29
- Last updated
- 2016-07-19
- Other registries' IDs
- eudract:2010-024454-10
- Results first posted
- 2016-02-11
- Limitations and caveats
Boehringer Ingelheim (BI) decided to stop further inclusion of patients and stop further treatment with the combination of Afatinib and Vinorelbine as of 03-May-2013. Recruitment into the trial was stopped by amendment in Jul 2013.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. | Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). |
| Primary | Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. | Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as \>182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). |
| Secondary | Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. | Objective response was defined on a patient level as a best response of CR or PR. |
| Secondary | Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days. | Objective response was defined on a patient level as a best response of CR or PR. |
| Secondary | Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. | Objective response was defined on a patient level as a best response of CR or PR. |
| Secondary | Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ). | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. | Objective response was defined on a patient level as a best response of CR or PR. |
| Secondary | Part A: Duration of Unconfirmed Objective Response. | From first drug administration until end of Part A, up to 929 days. | Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)). |
| Secondary | Part B: Duration of Unconfirmed Objective Response. | From first drug administration until end of Part B, up to 929 days. | Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS). |
| Secondary | Part A: Progression Free Survival. | From first drug administration until end of Part A, up to 713 days. | PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A. |
| Secondary | Part B: Progression Free Survival. | From first drug administration until end of Part B, up to 230 days. | PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Percentage of participants | NUMBER |
| PRIMARY | Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Percentage of participants | NUMBER |
| SECONDARY | Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Percentage of participants | NUMBER |
| SECONDARY | Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ). | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Duration of Unconfirmed Objective Response. | From first drug administration until end of Part A, up to 929 days. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Days | MEDIAN |
| SECONDARY | Part B: Duration of Unconfirmed Objective Response. | From first drug administration until end of Part B, up to 929 days. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Days | MEDIAN |
| SECONDARY | Part A: Progression Free Survival. | From first drug administration until end of Part A, up to 713 days. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Days | MEDIAN |
| SECONDARY | Part B: Progression Free Survival. | From first drug administration until end of Part B, up to 230 days. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Days | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | Part A: Afatinib Once Daily (OD). | 35 | 95% Confidence Interval 17 to 56 | Percentage of participants | |
Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | Part B: Afatinib Once Daily (OD)+V (Vinorelbine). | 20 | 95% Confidence Interval 3 to 56 | Percentage of participants | |
| Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Part A: Afatinib Once Daily (OD). | 31 | 95% Confidence Interval 14 to 52 | Percentage of participants | |
| Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Part B: Afatinib Once Daily (OD)+V (Vinorelbine). | 10 | 95% Confidence Interval 0 to 45 | Percentage of participants | |
| Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Part A: Afatinib Once Daily (OD). | 42 | 95% Confidence Interval 23 to 63 | Percentage of participants | |
| Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ). | Part B: Afatinib Once Daily (OD)+V (Vinorelbine). | 30 | 95% Confidence Interval 7 to 65 | Percentage of participants | |
| Part A: Duration of Unconfirmed Objective Response. | Part A: Afatinib Once Daily (OD). | NA | 95% Confidence Interval 57 to NA | Days | |
| Part B: Duration of Unconfirmed Objective Response. | Part B: Afatinib Once Daily (OD)+V (Vinorelbine). | 57 | 95% Confidence Interval 56 to 140 | Days | |
| Part A: Progression Free Survival. | Part A: Afatinib Once Daily (OD). | 110.5 | 95% Confidence Interval 58.0 to 386.0 | Days | |
| Part B: Progression Free Survival. | Part B: Afatinib Once Daily (OD)+V (Vinorelbine). | 106.0 | 95% Confidence Interval 36.0 to 190.0 | Days |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B). | 26 | |
| Part A | COMPLETED | Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B). | 10 | |
| Part A | NOT COMPLETED | Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B). | 16 | |
| Part B | STARTED | Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B). | 10 | |
| Part B | COMPLETED | Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B). | 7 | |
| Part B | NOT COMPLETED | Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B). | 3 |
Source ClinicalTrials.gov
Adverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: Afatinib Once Daily (OD). | 4 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Afatinib+V (Vinorelbine). | 5 | 10 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part A: Afatinib Once Daily (OD). | 1 | 26 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part B: Afatinib+V (Vinorelbine). | 8 | 10 | |
| other | Atrial flutter | Cardiac disorders | Part A: Afatinib Once Daily (OD). | 0 | 26 | |
| other | Atrial flutter | Cardiac disorders | Part B: Afatinib+V (Vinorelbine). | 1 | 10 | |
| other | Dry eye | Eye disorders | Part A: Afatinib Once Daily (OD). | 3 | 26 | |
| other | Dry eye | Eye disorders | Part B: Afatinib+V (Vinorelbine). | 0 | 10 | |
| other | Panophthalmitis | Eye disorders | Part A: Afatinib Once Daily (OD). | 0 | 26 | |
| other | Panophthalmitis | Eye disorders | Part B: Afatinib+V (Vinorelbine). | 1 | 10 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Afatinib Once Daily (OD). | ||
| Total, all-cause mortality | Part B: Afatinib+V (Vinorelbine). | ||
| Total, other adverse events | Part A: Afatinib Once Daily (OD). | 26 | 26 |
| Total, other adverse events | Part B: Afatinib+V (Vinorelbine). | 10 | 10 |
| Total, serious adverse events | Part A: Afatinib Once Daily (OD). | 12 | 26 |
| Total, serious adverse events | Part B: Afatinib+V (Vinorelbine). | 4 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27923043 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part A: Afatinib Once Daily (OD). vs Part B: Afatinib+V (Vinorelbine).: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01325428
GET https://conductscience.org/api/trials/v1/NCT01325428/events?page=2