Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary 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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-01-31

Brief Summary

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This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

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Detailed Description

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Upon determination of eligibility, patients will receive:

Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery

Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin + Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy. Patients with positive estrogen and/or progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Intervention Type DRUG

Doxorubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

To be included in this study, you must meet the following criteria:

* Histologically proven breast cancer
* Females, age greater than 18 years
* Ability to perform activites of daily living with minimal assistance
* Normal cardiac function
* Adequate bone marrow, liver and kidney
* Signed informed consent prior to beginning specific protocol procedures

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

* Prior systemic anticancer therapy for breast cancer
* Prior anthracycline or taxane based chemotherapy for any malignancy
* Pregnant or breast-feeding women.
* Pre-existing moderate to severe motor or sensory neurotoxicity
* Other serious illness or medical condition

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No