Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

This study has been terminated.
(due to slow recruitment of patients)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00461344
First received: April 17, 2007
Last updated: April 1, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Ductal Carcinoma
Drug: Docetaxel
Drug: Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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) [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: July 2004
Study Completion Date: August 2007
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461344

Sponsors and Collaborators
Sanofi
Investigators
Study Director: László Erős sanofi-aventis Hungary
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00461344     History of Changes
Other Study ID Numbers: XRP6976D_2504
Study First Received: April 17, 2007
Last Updated: April 1, 2008
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Sanofi:
Breast

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Doxorubicin
Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014