Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

NCT ID: NCT00524810

Last Updated: 2011-06-30

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-06-30

Brief Summary

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Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

Detailed Description

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Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caelyx - Taxotere

Group Type EXPERIMENTAL

Pegylated liposomal doxorubicin

Intervention Type DRUG

Caelyx 30 mg/m² day 1 every 3 weeks

Docetaxel

Intervention Type DRUG

Taxotere 75 mg/m² day 2 every 3 weeks

Interventions

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Pegylated liposomal doxorubicin

Caelyx 30 mg/m² day 1 every 3 weeks

Intervention Type DRUG

Docetaxel

Taxotere 75 mg/m² day 2 every 3 weeks

Intervention Type DRUG

Other Intervention Names

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Caelyx Taxotere

Eligibility Criteria

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Inclusion Criteria

* first metastatic chemo line
* presence of measurable or bone lesion
* at least one lesion outside the radiated areas
* can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks

Exclusion Criteria

* only local tumoral progression
* symptomatic cerebral metastasis
* neuropathy \> NCI-CTC 2
* previous cancer within 10 years \_ previous cancer within 10 years
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

Responsible Party

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ARCAGY-GINECO

Principal Investigators

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Laure CHAUVENET, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Hôpital HOTEL DIEU - Paris

Locations

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Hôpital HOTEL DIEU

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CAPYTTOLE

Identifier Type: -

Identifier Source: org_study_id