Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

NCT00461344 | Terminated Phase 2

• 1 other identifier: XRP6976D_2504
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Ductal Carcinoma

Keywords

Breast

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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)

Interventions

Docetaxel DRUG

Doxorubicin DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Carcinoma, Ductal

Interventions

Docetaxel; Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• László Erős

  sanofi-aventis Hungary

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: July 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: August 1, 2007
• Last Updated: April 3, 2008

Record last verified: 2008-04