Clinical trial · Interventional
Lapatinib and Radiation Therapy in Treating Patients With Locally Recurrent or Chemotherapy-Refractory Locally Advanced or Metastatic Breast Cancer
Phase I Radiosensitization Study of GW572016 With Biologic Correlates in Locoregionally Recurrent Breast Cancer
- 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)
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving lapatinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with radiation therapy in treating patients with locally recurrent or chemotherapy-refractory locally advanced or metastatic breast cancer.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| lapatinib ditosylate | Drug | Lapatinib | ALIAS |
| microarray analysis | Genetic | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| TdT-mediated dUTP nick end labeling assay | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GW572016
- interventionNames
- Drug: lapatinib ditosylate
- Genetic: TdT-mediated dUTP nick end labeling assay
- Genetic: gene expression analysis
- Genetic: microarray analysis
- Other: immunohistochemistry staining method
- Procedure: biopsy
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Toxicity as assessed by NCI CTCAE v3.0
- timeFrame
- 4-5 years
- measure
- Inhibition of receptor and downstream signal transduction pathway activation in tumor tissue as assessed by IHC
- timeFrame
- 4-5 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer meeting 1 of the following criteria:
* Locally recurrent disease
* Locally advanced disease AND meets the following criterion:
* Chemotherapy-refractory disease (achieved \< partial response to ≥ 3 courses of neoadjuvant chemotherapy)
* Metastatic disease
* Evaluable disease by exam and/or imaging studies
* Amenable to serial biopsies by skin punch, core biopsy, or fine-needle aspiration
* Unresectable disease after standard neoadjuvant chemotherapy
* Resectability must be determined by a surgical oncologist prior to treatment
* Stable CNS metastases allowed
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* Life expectancy \> 12 weeks
* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow and retain oral medication
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Cardiac ejection fraction normal by ECHO or MUGA
* No other malignancy within the past 5 years
* No concurrent disease or condition that would preclude study participation
* No ongoing coagulopathy
* No active severe infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* At least 3 weeks since prior and no other concurrent systemic therapy for breast cancer
* At least 14 days since prior and no concurrent herbal or alternative medicine
* At least 14 days since prior and no concurrent dietary supplement
* At least 14 days since prior CYP3A4 inducers
* At least 7 days since prior CYP3A4 inhibitors
* No antacid within 1 hour before or after study drug administration
* Concurrent bisphosphonate allowed
* No concurrent oral glucocorticosteroid \> 1.5 mg of dexamethasone (or equivalent)References
Publications (0)
Data not yet available