Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00461344

Enrollment

Registered

2007-04-18

Start date

2004-07-31

Completion date

2007-08-31

Last updated

2008-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ductal Carcinoma

Keywords

Breast

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)

Interventions

DRUGDocetaxel

DRUGDoxorubicin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026