Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Ductal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00461344
• Other study ID #: XRP6976D_2504
• Status: Terminated
• Phase: Phase 2
• First received: April 17, 2007
• Last updated: April 1, 2008
• Start date: July 2004
• Est. completion date: August 2007

Study information

• Verified date: April 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2007
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Ductal
• Ductal Carcinoma

Intervention

Drug:
• Docetaxel

• Doxorubicin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
Secondary	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)			Yes