At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive carcinoma of the female breast
- ✓0-3 positive axillary lymph nodes; node-negative patients must have high-risk disease (e.g., tumors >=1 cm or ER/PR-negative of any size)
- ✓Negative tumor margins for invasive cancer and DCIS (LCIS acceptable at margin)
- ✓Registration within 84 days of last breast surgery; all primary breast and axillary node surgery must be completed prior to enrollment
- ✕Locally advanced, inflammatory, or metastatic breast cancer
- ✕Involvement of dermal lymphatics on pathology
- ✕Prior chemotherapy or trastuzumab for this malignancy (tamoxifen for ≤4 weeks allowed)
- ✕Prior anthracycline chemotherapy for any disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study
In Brief
A Phase 3 clinical trial evaluating AC regimen, cyclophosphamide, and 2 other interventions for Breast Cancer. Completed, enrolled 3,871 participants across 527 sites in 2 countries.
Detailed Summary
This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer
Study Details
Timeline
Interventions
Given IV
Given IV
Given IV
Given IV