Clinical trial · Interventional
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
NCT00300781CI-TRIAL-00034334completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neratinib | Drug | Neratinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neratinib 240 mg, with prior trastuzumab
- description
- Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
- interventionNames
- Drug: neratinib
- type
- EXPERIMENTAL
- label
- Neratinib 240 mg, no prior trastuzumab
- description
- Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
- interventionNames
- Drug: neratinib
Primary outcomes (1)
- measure
- 16-week Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV * Progression following at least 6 weeks of standard doses of Herceptin (Arm A only) * Over-expression of HER2 * Tumor tissue available and adequate for analysis at screening * At least one measurable lesion Exclusion Criteria: * Prior treatment with Herceptin (Arm B only) * More than 4 prior cytotoxic chemotherapy regimens * Subjects with bone or skin as the only site of measurable disease * Inadequate cardiac function * Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1 * Active central nervous system metastases * Pregnant or breastfeeding women * Inability to swallow the HKI-272 capsules
References
Publications (0)
Data not yet available
No reference posted for this study.