Clinical trial · Interventional
Myocet Plus Endoxan for Older Patients With Breast Cancer
Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual
Summary
Brief summary (as posted)
This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment
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 |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Liposomal-encapsulated doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Cyclofosfamide/Liposomal-encapsulated doxorubicin
- interventionNames
- Drug: Cyclophosphamide
- Drug: Liposomal-encapsulated doxorubicin
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Objective responses confirmed by CT or MRI every 3 months
Secondary outcomes (3)
- measure
- Toxicity profile
- timeFrame
- Toxicity assessment every month
- measure
- Time to Tumor Progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed metastatic breast adenocarcinoma * No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable. * Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * Performance status (WHO) 0-2 * Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases) * Adequate renal function (serum creatinine \<1.5 times the upper normal limit) * Adequate cardiac function (LVEF within normal limits) * Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) * No radiation of measurable disease (except brain metastases) * No progressive brain metastases according to clinical or radiological criteria * No brain metastases without prior radiation therapy * Written informed consent Exclusion Criteria: * Active infection * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period * Other invasive malignancy except non-melanoma skin cancer * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women
References
Publications (0)
Data not yet available