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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


Phase 2
18 Years
70 Years
Not Enrolling
Female
Ductal Carcinoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

László Erős

Investigator Role:

Study Director

Investigator Affiliation:

sanofi-aventis Hungary

Authority:

Hungary: National Institute of Pharmacy

Study ID:

XRP6976D_2504

NCT ID:

NCT00461344

Start Date:

July 2004

Completion Date:

August 2007

Related Keywords:

  • Ductal Carcinoma
  • Breast
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

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