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Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Primary Purpose

Ductal Carcinoma

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Docetaxel

Doxorubicin

About this trial

This is an interventional treatment trial for Ductal Carcinoma focused on measuring Breast

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer

Secondary Outcome Measures

Secondary: 1. Clinical response rate 2. to investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer 3. Type of surgery (radical/conservative)

Full Information

NCT ID

NCT00461344

First Posted

April 17, 2007

Last Updated

April 1, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00461344

Brief Title

Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Official Title

A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel + Anthracycline x 4 Cycles Followed by Docetaxel Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed ≥ 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®- Based Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Terminated

Why Stopped

due to slow recruitment of patients

Study Start Date

July 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ductal Carcinoma

Keywords

Breast

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Primary Outcome Measure Information:

Title

Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

László Erős

Organizational Affiliation

sanofi-aventis Hungary

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

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