Phase 3
Completed N=633
Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Source: ClinicalTrials.gov NCT00024102 ↗Enrolled (actual)
633
Serious AEs
9.5%
Results posted
Jan 2013
Primary outcomePrimary: Relapse-free Survival Rates at 2.4 Years — 11; 20; 89; 80 percentage of participants — p=<0.001
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse-free Survival Rates at 2.4 Years |
11; 20; 89; 80 | <0.001 sig |
| SECONDARY Overall Survival Rate at 2.4 Years |
93; 88 | 0.02 sig |
| SECONDARY Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. |
92; 109; 101 | — |
Eligibility Criteria
- Patients with operable, histologically confirmed adenocarcinoma of the female breast.
- TNM Stage per AJCC Cancer Staging Manual 6th edition:
- T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0
- Patients with bilateral, synchronous breast cancer are eligible as long as one primary tumor meets the criteria above.
- Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.
Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.
- Age 65 years or older
- Performance status 0-2 (Common Toxicity Criteria).
- Prior treatment:
- Surgical resection -
- All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered ≤ 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.
- Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.
- Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor 1,500/µl
- Platelet count ≥100,000/µl
- Calculated Creatinine Clearance > 30 mL/min
- Total bilirubin ≤ ULN
Data sourced from ClinicalTrials.gov (NCT00024102). 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.