Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With 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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-08-31

Brief Summary

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Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer

Secondary:

* Clinical response rate
* To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer
* Type of surgery (radical/conservative)

Detailed Description

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Conditions

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Ductal Carcinoma

Keywords

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Breast

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

Eligibility Criteria

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Inclusion Criteria

* Histologically verified breast cancer
* Large (≥ 3 cm) breast cancer
* IIb-IIIa stage
* ECOG (Eastern Cooperative Oncology Group) status: 0-1-2
* Adequate bone marrow reserve: (Haemoglobin ≥ 12g/l, Absolute Neutrophil Count (ANC) ≥ 2.0x 10\^9, Platelets ≥100 000)
* Laboratory results:
* Bilirubin ≤ Upper Limit Normal (ULN)
* Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 ULN, Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 ULN,
* Alk.phosph. ≤ 5.0 ULN,
* Creatinin ≤ ULN, if borderline calculated at ≤ 60ml/min
* Normal cardiac function (the result of Left Ventricular Ejection Function (LVEF) must be above the lower limit of normal for the institution)
* Negative pregnancy test
* Hormonal receptor status assessed

Exclusion Criteria

* Pregnancy or lactation
* SGOT and/or SGPT \> 1.5 upper limit normal, associated with Alk.phosph \> 2.5 ULN
* Serious medical condition including but not limited to:
* Uncontrolled hypertension
* Active ulcus pepticum
* Non-stable diabetes mellitus
* Other contraindication of steroid treatment
* Myocardial infarction within the last 6 months prior study entry
* Significant neurologic/psychiatric disorders
* Active infection
* Peripheral neuropathy grade ≥ 2
* Unstable angina
* Severe arrhythmia
* Participation in other clinical trial
* Prior surgery, chemotherapy, hormonotherapy for breast cancer
* Past or current history of neoplasm other than breast cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 7 years
* History of hypersensitivity to the investigational products or to drugs with similar chemical structures
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
* Treatment with any investigational product in the last 1 month before study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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László Erős

Role: STUDY_DIRECTOR

sanofi-aventis Hungary

Other Identifiers

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XRP6976D_2504

Identifier Type: -

Identifier Source: org_study_id