Clinical trial · Interventional
Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients
A Randomized Multicenter Trial of Neoadjuvant Taxotere (T) and Adriamycin/Cytoxan (Ac): A Validation
NCT00206518CI-TRIAL-00046223TACACcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn if the biomarker information obtained (learned or received) from the earlier studies can tell us whether or not Taxotere and/or Adriamycin/Cytoxan can cause tumors to become smaller.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin/Cytoxan | Drug | — | UNRESOLVED |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| Taxotere/Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Taxotere/Docetaxel
- description
- Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
- interventionNames
- Drug: Taxotere/Docetaxel
- Drug: doxorubicin
- type
- EXPERIMENTAL
- label
- B: AC Adriamycin/Cytoxan
- description
- In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients must be female. 2. Signed informed consent. 3. Primary breast cancers must be of clinical and/or radiologic size \>3 cm, and deemed surgically operable. 4. Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential. 5. Adequate bone marrow function: * Hematocrit of greater than 30%, * total neutrophil count must be \>1.5 x 10\^9/L and * platelets of \> 100 x 10\^9/L prior to the start of any cycle. 6. Renal function tests: * creatinine within 1.5 times of the institution's upper limit of normal (ULN). 7. Liver function tests: * Total serum bilirubin within ULN, and * liver transaminases within 2.5 times ULN, and * alkaline phosphatase within 5 times ULN. 8. Electrocardiogram showing no acute ischemic changes. 9. Performance status (World Health Organization \[WHO\] scale) \<2. 10. Age \> 18 years. 11. Patients older than 70 years of age should have left ventricular ejection fraction within ULN by multigated acquisition scan (MUGA) or 2D echocardiogram. Exclusion Criteria: 1. Patients with metastatic breast cancer. 2. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential. 3. Women who are lactating or breastfeeding. 4. Severe underlying chronic illness or disease. 5. Peripheral neuropathy - grade 2 or greater. 6. Patients on other investigational drugs while on study will be excluded. 7. Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease. 8. Prior taxane or anthracycline chemotherapy for malignancy. 9. Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80. 10. No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
References
Publications (0)
Data not yet available
No reference posted for this study.