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Optimizing Postoperative Chemotherapy for Breast Cancer
Untitled Document
Name of the Trial
Phase III Randomized Study of Adjuvant Cyclophosphamide and Doxorubicin Versus
Single-Agent Paclitaxel in Women With Operable Breast Cancer and 0-3 Positive
Axillary Lymph Nodes (CALGB-40101). See the protocol
summary.
Principal Investigator
Dr. Lawrence Shulman, Cancer and Leukemia Group B
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Dr. Lawrence Shulman
Principal Investigator |
Why This Trial Is Important
Women who undergo surgery for early-stage breast cancer are often treated with
postoperative (adjuvant) chemotherapy if they are deemed to have a high risk
for recurrence. High risk may be indicated by the presence of cancer in the
axillary lymph nodes near the breast that contained the tumor, a large tumor,
an absence of hormone receptors in the tumor cells, or other characteristics.
Adjuvant chemotherapy is given in hopes of preventing or delaying recurrence
of cancer and its spread to other organs.
Currently, adjuvant chemotherapy with the drugs cyclophosphamide
and doxorubicin
is considered standard
of care. However, this combination carries with it the risk of serious
long-term complications, including greater chances of heart problems and development
of acute
leukemia as a secondary cancer. Researchers want to know if adjuvant
chemotherapy using a different drug, paclitaxel,
is as effective as cyclophosphamide and doxorubicin in preventing recurrences,
with fewer immediate and long-term side effects.
In this trial, women with early-stage breast cancer deemed by their doctors
to be at high risk for recurrence will receive adjuvant chemotherapy with either
cyclophosphamide and doxorubicin or paclitaxel given four times over an 8-week
period.
"Paclitaxel has been used in breast cancer treatment for more than 20
years," said Dr. Shulman, "and it has shown equivalency to combination
chemotherapy in other breast cancer settings. It hasn't been tested as a single
agent, however, in women with early-stage disease.
"In this group of patients, we estimate that 80 to 85 percent will be
long-term survivors, so the long-term side effects of treatment are very important
considerations," added Dr. Shulman. "Paclitaxel hasn't demonstrated
the long-term cardiac or leukemia risks of the doxorubicin/cyclophosphamide
combination, and it usually causes fewer short-term side effects as well."
Nevertheless, treatment with paclitaxel is not without risks, Dr. Shulman noted.
"One of the common side effects of paclitaxel is peripheral neuropathy,
a loss of sensation or painful sensation in the extremities. Usually the neuropathy
is mild and doesn't persist long, but it is a concern.
"A companion study will look at the quality of life of the women receiving
these breast cancer treatments so that we will better understand their side
effects," he said.
For More Information
See the lists of entry
criteria and trial
contact information or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237). The toll-free call is confidential.
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