Clincosm LogoSign in Get a demo

Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT00461344
Collaborator
(none)
20
Enrollment
37
Duration (Months)

Study Details

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)

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Jun 1, 2005
Actual Study Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: László Erős, sanofi-aventis Hungary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00461344
Other Study ID Numbers:
  • XRP6976D_2504
First Posted:
Apr 18, 2007
Last Update Posted:
Apr 3, 2008
Last Verified:
Apr 1, 2008
Keywords provided by , ,
Breast
Additional relevant MeSH terms:
Carcinoma, Ductal
Docetaxel
Doxorubicin

Study Results

No Results Posted as of Apr 3, 2008