Breast Neoplasms, Neoplasm Metastasis
Conditions
Brief summary
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.
Interventions
DRUGEdotecarin
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DR) | — |
| Time to tumor progression (TTP) | — |
| Time to treatment failure (TTF) | — |
| Overall survival (OS) | — |
| Clinical benefit | — |
| Time to tumor response (TAR) | — |
| analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18] | — |
| performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2] | — |
| Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC] | — |
| [Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities. | — |
| Plasma pharmacokinetic parameters | — |
| ie, a composite profile of pain intensity | — |
Countries
Australia, Belgium, France, United States
Outcome results
None listed