Breast Neoplasms
Conditions
Brief summary
To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.
Interventions
DRUGdocetaxel
DRUGPF-3512676
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients with confirmed advanced breast cancer. * Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen. * Patients with adequate general well-being, kidney and liver function.
Exclusion criteria
* Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study. * Patients who have had prior chemotherapy for advanced breast cancer. * Patients of child-bearing potential who are unwilling to use contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Tumor assessment every 6 weeks until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression | — |
| Overall Survival - Patients will be followed for survival | — |
| Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up | — |
| Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy | — |
Outcome results
None listed