Phase 3
Completed N=1,961
TAC Versus TC for Adjuvant Breast Cancer
Breast Cancer
Source: ClinicalTrials.gov NCT00493870 ↗
Enrolled (actual)
1,961
Serious AEs
30.7%
Results posted
Mar 2023
Primary outcomePrimary: 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients — 91.1; 93.2 percentage of participants — p=0.05
◆ Published Evidence
Established
22citations · ~11 / year
Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]).
Summary
The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.
Linked Publications
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Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients |
91.1; 93.2 | 0.05 |
| PRIMARY 3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients |
91.3; 93.2 | — |
| SECONDARY 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients |
90.9; 93.0; 96.8; 96.8; 91.9; 94.5 | — |
| SECONDARY 3-year DFS-DCIS, OS and RFI Among Per-protocol Patients. |
91.1; 93.0; 96.8; 96.8; 92.1; 94.5 | — |
| SECONDARY Number and Frequency of Participants by TOP2A Status by Study Treatment |
14; 14; 131; 128; 479; 489 | — |
| SECONDARY 3-year DFS Stratified by TOP2A Among TC Arm |
85.1; 82.8; 93.8 | — |
| SECONDARY 3-year DFS Stratified by TOP2A Among TAC Arm |
100; 90.9; 93.2 | — |
Eligibility Criteria
Inclusion Criteria
A woman will be eligible for inclusion in this study if she meets all of the following criteria:
- Age >18 to 5 years ago
- Has an ECOG Performance Status (PS) 0-1
- Has laboratory values of: See protocol for specific details
- Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
- Has normal cardiac function as evidenced by a LVEF >50%, but WNL by institutional standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same modality must be used consistently throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be WNL by institutional standard.
- Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease
- Has had baseline bilateral mammography
- It has been Grade 1
- Has had a major organ allograft or condition requiring chronic immunosuppression (ie, kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible.
- Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
- Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the diagnosis or assessment of any of the study drugs
- In an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible.
- Is pregnant or breastfeeding
- Is deemed unable to comply with requirements of study
Data sourced from ClinicalTrials.gov (NCT00493870) 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.