Phase III Randomized Study of Adjuvant CA (Cyclophosphamide/Doxorubicin) Comparing Standard- vs Intermediate- vs High-Dose Doxorubicin, with vs without Subsequent Paclitaxel, in Women with Node-Positive Breast Cancer
|Phase III||Treatment||Closed||over 18||NCI||CLB-9344|
E-C9344, NCCTG-943051, SWOG-9410, INT-0148
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
- At least 19 years old
- At least one lymph node positive for cancer
- No inflammatory breast cancer
- No more than 12 weeks since surgery to remove the tumor
- For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned to receive one of three different doses of doxorubicin plus cyclophosphamide for 3 months. Within each of these groups, patients will be further randomized to receive either 3 additional months of chemotherapy with paclitaxel or no further treatment. Some patients from all groups will also receive tamoxifen by mouth once a day for 5 years. Patients will be evaluated every 3 months for 1 year, every 6 months for 2 years, and once a year thereafter.
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.
Trial Lead Organizations
Cancer and Leukemia Group B
|I. Craig Henderson, MD, Protocol chair|
Eastern Cooperative Oncology Group
|Lori Goldstein, MD, Protocol chair|
Southwest Oncology Group
|Silvana Martino, DO, Protocol chair|
North Central Cancer Treatment Group
|James Ingle, MD, Protocol chair|