Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

combination of CP-751,871 + docetaxel administered

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

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.

Arm B

chemotherapy

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

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

Interventions

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CP-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.

Intervention Type DRUG

Docetaxel

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No