Clinical trial · Interventional
Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer
A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer
NCT00678626CI-TRIAL-00017767withdrawnPhase 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)
This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.
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 |
|---|---|---|---|
| CP-751,871 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- combination of CP-751,871 + docetaxel administered
- interventionNames
- Drug: CP-751,871
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- chemotherapy
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 3 years
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB). * Her-2negative breast cancer or unknown Her-2 status. * at least 1 measurable lesion as defined by RECIST. * ECOG status 0-1 * adequate bone marrow, hepatic and renal function. * left ventricular ejection fraction of greater than or equal to 50%. * willingness to discontinue hormonal therapy. Exclusion Criteria: * any previous chemotherapy for advanced disease. * prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization. * symptomatic brain metastases. * prior anti-IGF-1R based investigational therapy. * peripheral neuropathy greater than grade 2.
References
Publications (0)
Data not yet available
No reference posted for this study.