---
title: Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy
nct_id: NCT00903656
overall_status: TERMINATED
phase: PHASE2
sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
study_type: INTERVENTIONAL
primary_condition: Metastatic Breast Cancer
countries: Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00903656.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00903656"
ct_last_update_post_date: 2013-12-24
last_seen_at: "2026-05-12T07:08:51.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy

**Official Title:** Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy - a Phase II Study

**NCT ID:** [NCT00903656](https://clinicaltrials.gov/study/NCT00903656)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Caelyx was not available anymore
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Arbeitsgemeinschaft medikamentoese Tumortherapie
- **Collaborators:** GlaxoSmithKline
- **Conditions:** Metastatic Breast Cancer
- **Start Date:** 2009-05
- **Completion Date:** 2012-05
- **CT.gov Last Update:** 2013-12-24

## Brief Summary

The aim of this study is to evaluate the potential of a Lapatinib plus Caelyx combination therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity profile, in the treatment of metastatic breast cancer following failure of prior trastuzumab.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Female patients, age ≥ 18 years
* Advanced or metastatic breast cancer, histologically confirmed
* Documented HER2 overexpression (IHC 3+ and/or FISH positive)
* At least one measurable lesion according to RECIST criteria. Patients with bone-only lesions are not eligible for study entry
* Documented disease progression
* Patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting
* Life expectancy of at least 12 weeks
* Performance status 0-1
* Cardiac ejection fraction \>= 50% as measured by echocardiogram or MUGA scan
* Adequate hematology, liver and renal function

Exclusion Criteria:

* Pregnant or lactating women
* Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
* Severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (CHF) or cardiac disease requiring a device)
* Ejection fraction below the institutional normal limit
* Maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin
* Active bacterial, viral or fungal infection
* Patients with clinically apparent brain metastases
* Positivity for HIV, Hepatitis B or C
* History of other malignancy; patients who have been disease-free for 5 years
* Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial
* Known hypersensitivity to the study drugs Lapatinib and Caelyx or their excipients
```

## Arms

- **Caelyx/Lapatinib** (EXPERIMENTAL)

## Interventions

- **doxorubicinhydrochloride, Lapatinib** (DRUG) — Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles

## Primary Outcomes

- **Efficacy of a Lapatinib plus Caelyx combination regimen in the treatment of advanced metastatic breast cancer, in terms of overall response rates (complete or partial response)determined by RECIST**

## Secondary Outcomes

- **Safety profile**
- **Occurrence of clinically apparent brain metastases**
- **Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks)**
- **Quality of Life**

## Locations (1)

- Uniklinik Salzburg, Salzburg, State of Salzburg, Austria

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uniklinik salzburg|salzburg|state of salzburg|austria` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00903656*  
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