Phase 3
Completed N=1,060
Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
Source: ClinicalTrials.gov NCT00121992 ↗Enrolled (actual)
1,060
Serious AEs
13.3%
Results posted
Dec 2020
Primary outcomePrimary: Disease-free Survival (DFS) Events — 127; 112 events
◆ Published Evidence
Highly cited
208citations · ~13 / year
Adjuvant docetaxel for high-risk, node-negative breast cancer.
Summary
This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:
* TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
* FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
Linked Publications
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Adjuvant docetaxel for high-risk, node-negative breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival (DFS) Events |
127; 112 | — |
| SECONDARY Overall Survival (OS) |
57; 53 | — |
| SECONDARY The Number of Participants Who Experienced Adverse Events (AE) |
519; 532; 88; 151; 22; 119 | — |
| SECONDARY Best Score During Study for Global Health Status Scale |
79.30; 77.78 | — |
| SECONDARY Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup |
6; 6 | — |
| SECONDARY Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup |
50; 37 | — |
| SECONDARY Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup |
6; 5 | — |
| SECONDARY Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup |
29; 28 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.
- Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.
- Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.
- Patients without proven metastatic disease.
- Estrogen and progesterone receptors performed on the primary tumour prior to randomization.
- Age between 18 years and 70 years.
- Karnofsky performance status index > 80 %.
- Adequate hepatic, renal and heart functions.
- Adequate hematology levels.
- Negative pregnancy test
Exclusion Criteria
- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
- Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
- Prior radiation therapy for breast cancer.
- Bilateral invasive breast cancer.
- Pregnant, or lactating patients.
- Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .
- Any T4 or N1-3 or M1 breast cancer.
- Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.
- Other serious illness or medical condition
- Past or current history of neoplasm other than breast carcinoma.
- Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.
- Lobular carcinoma in-situ (LCIS) of the breast.
- Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose
- Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.
- Definite contraindications for the use of corticosteroids.
- Concurrent treatment with other experimental drugs.
- Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- Concurrent treatment with any other anti-cancer therapy.
- Male patients.
Data sourced from ClinicalTrials.gov (NCT00121992) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.