Clinical trial · Interventional
Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic 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)
This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.
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 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Edotecarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
Secondary outcomes (12)
- measure
- Time to tumor response (TAR)
- measure
- Duration of response (DR)
- measure
- Time to tumor progression (TTP)
- measure
- Time to treatment failure (TTF)
- measure
- Overall survival (OS)
- measure
- Clinical benefit
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent * Must have received any chemotherapy regimen in the past * Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease * Must have measurable (by imaging techniques) disease * Adequate bone marrow, liver and renal function * Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures. Exclusion Criteria: * Received more than 2 prior chemotherapy regimens for metastatic disease * Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor * Enrolled in another clinical intervention study * Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods * Cardiac or thrombotic event in the last 12 months * Brain metastases
References
Publications (0)
Data not yet available