Clinical trial · Interventional
A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer
NCT00471159CI-TRIAL-00017769withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| PF-3512676 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-free survival
- measure
- Tumor assessment every 6 weeks until disease progression
Secondary outcomes (4)
- measure
- Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
- measure
- Overall Survival - Patients will be followed for survival
- measure
- 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
- measure
- Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.