US Oncology 9735.
| Methods | Randomised controlled trial Randomisation method not specified Patients stratified by age and nodal status Accrual July 1997 to December January 2000 Baseline characteristics well balanced between treatment arms | |
| Participants | Female, premenopausal and postmenopausal Patients aged 18 to 75 years. Median age: 52 years (28 to 78) Following surgery for operable breast cancer, stage I to III Approximately 48% node negative and 52% node positive included Locally advanced tumours excluded HR positive: 71% of patients | |
| Interventions | ARM 1 (AC):
AC × 4 21‐day cycles (doxorubicin 60 mg/m², cyclophosphamide 600 mg/m² day 1)
ARM 2 (TC):
TC × 4 21‐day cycles (docetaxel 75 mg/m², cyclophosphamide 600 mg/m² day 1) Tamoxifen 20 mg/d for 5 years given to all patients with ER and/or PR positive Radiotherapy as indicated |
|
| Outcomes | Primary endpoints:
Secondary endpoints:
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| Notes | Median follow‐up: 84 months
Trial identifier not retrieved Supported by Sanofi‐Aventis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomly assigned" No further details provided in the trial report |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
| Blinding of outcome assessment ‐ OS (detection bias) | Low risk | Assessment of overall survival unlikely to be influenced by no or incomplete blinding |
| Blinding of outcome assessment ‐ DFS & Toxicity (detection bias) | Unclear risk | Quote: "follow‐up was done at 6‐month intervals for 5 years and annually thereafter to 7 years. Lab work, annual chest X‐rays, mammograms (if indicated), and assessments of health status occurred at these visits" Quote: "toxicity was assessed at each patient visit and for 30 days after the last dose" Graded according to NCI CTC Comment: no independent adjudication committee involved in assessing these outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients reported as randomised (1016) accounted for in the results presented: 506 in the TC group and 510 in the AC group. Efficacy analyses conducted as intention‐to‐treat and safety analyses including patients who had received at least 1 dose of study drug |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes in the methods section reported in the results section of the trial publication |
| Other bias | Low risk | Quote: "patient characteristics were well balanced between treatment arms" |
AC: doxorubicin, cyclophosphamide. CBC: complete blood count. CMF: cyclophosphamide, methotrexate, fluorouracil. CR: complete response. CT: computed tomography. DCIS: ductal carcinoma in situ. DDFS: distant disease‐free survival. DFS: disease‐free survival. DMC: data monitoring committee. EC: epirubicin, cyclophosphamide. ER: oestrogen receptor. EV: epirubicin, vinorelbine. FAC: fluorouracil, doxorubicin, cyclophosphamide. FEC: fluorouracil, epirubicin, cyclophosphamide. G‐CSF: granulocyte colony‐stimulating factor. HER2: human epidermal growth factor 2. HR: hormone receptor. ITT: intention‐to‐treat. LVEF: left ventricular ejection fraction. NCI‐CTC: National Cancer Institute Common Toxicity Criteria. OS: overall survival. PR/PgR: progesterone receptor. QoL: quality of life. SD: stable response. TAC: docetaxel, doxorubicin, cyclophosphamide. V: vinorelbine.