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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00678626

Enrollment

Registered

2008-05-15

Start date

2009-04-30

Completion date

2011-09-30

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.

Brief summary

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.

Interventions

DRUGCP-751,871

Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.

DRUGDocetaxel

Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	3 years

Secondary

Measure	Time frame
Overall Response	3 years
Overall Survival	3 years
Safety and tolerability	3 years
Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)	3 years
Pharmacokinetics of CP-751,871	3 years
Optional tissue markers of the IGF-1R pathway from tumor tissue obtained	3 years
Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire	3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026