Clinical trial · Interventional
PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer
A Phase I/II Study of PTK787 in Combination With Trastuzumab in Patients With Newly Diagnosed HER2 Overexpressing Locally Recurrent or Metastatic Breast Cancer: Hoosier Oncology Group Trial BRE04-80
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low patient enrollment; toxicities
Summary
Brief summary (as posted)
HER2 gene amplification increases VEGF production in breast cancers; combined inhibition of HER2 and VEGF enhances response in xenograft models. The upregulation of VEGF in HER2-overexpressing breast cancers may contribute to the aggressive phenotype observed in HER2-positive breast cancer. New therapeutics targeting VEGF and/or its receptors may enhance the efficacy of trastuzumab monotherapy. This trial will investigate the safety and efficacy of combined HER2 and VEGF inhibition.
Conditions
Conditions (1)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTK787 | Drug | Vatalanib | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group Assignment
- description
- Trastuzumab + PTK787 for HER2 positive patients
- interventionNames
- Drug: PTK787
- Drug: Trastuzumab
Primary outcomes (4)
- measure
- Phase I Cohorts:
- timeFrame
- 18 months
- measure
- The primary objective is to ensure the safety and tolerability of the combination of Trastuzumab and PTK787,
- timeFrame
- 18 months
- measure
- Phase II Cohorts:
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease. Locally recurrent disease must not be amenable to resection OR radiation with curative intent. * Patient's disease may not involve more than 3 metastatic sites. In addition, patient may not be symptomatic from pulmonary metastasis or have liver metastasis involving \> 50% of parenchyma. * HER2 gene amplification by FISH. HER protein overexpression by immunohistochemistry will not be sufficient for entry. * Negative pregnancy test Exclusion Criteria: * No prior cytotoxic chemotherapy or trastuzumab for locally recurrent or metastatic disease. * No prior treatment with any VEGF inhibiting agents * No history or presence of central nervous system (CNS) disease. * No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy. * No major surgery within 28 days prior to being registered for protocol therapy. * No uncontrolled hypertension (SBP \> 170, DBP \> 90), history of labile hypertension or history of poor compliance with antihypertensive therapy. * No requirement for therapeutic anticoagulation, regular aspirin (\> 325 mg/day) or NSAID use. * No current breast feeding. * No impairment of gastrointestinal (GI) function that may significantly alter the absorption of PTK787. * No evidence of other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
References
Publications (0)
Data not yet available