Adjuvant Bisphosphonates for Breast Cancer
Untitled Document
Name of the Trial
Phase III Randomized Study of Adjuvant Zoledronate Versus Clodronate Versus
Ibandronate in Women With Resected Primary Stage I-III Adenocarcinoma of the
Breast (SWOG-S0307). See the protocol
summary.
Principal Investigators
Dr. Julie Gralow and Dr. Robert Livingston, SWOG;
Dr. James Ingle, NCCTG; Dr. Carla Falkson,
ECOG; Dr. Alexander Paterson, NSABP;
Dr. Elizabeth Dees, CALGB; and Dr. Mark
Clemons, NCIC
Clinical Trials Group.
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Dr. Julie Gralow
Principal Investigator |
Why This Trial Is Important
When breast cancer spreads (metastasizes), it often spreads first to the bones.
Bone metastases can lead to complications such as pain, fractures, spinal cord
compression, bone marrow suppression, and hypercalcemia (abnormally high blood
calcium).
Drugs called bisphosphonates have been shown to slow the progression of bone metastases and reduce skeletal complications in women with metastatic breast
cancer. Bisphosphonates may also prevent the development of bone metastases
in newly diagnosed patients with no evidence of metastasis.
"Breast cancer cells stimulate bone cells called osteoclasts, and these
osteoclasts in turn stimulate the growth of breast cancer cells," said
Dr. Gralow. "A bisphosphonate called clodronate has been shown to interrupt
the relationship between osteoclasts and breast cancer cells in early stage
breast cancer. With this trial, we're comparing clodronate with two newer, more-potent
bisphosphonateszoledronate and ibandronate.
"If we can eliminate bone as a safe harbor for breast cancer cells in
women who would have experienced bone metastases as the first site of metastasis,
we may be able to prevent the spread of breast cancer in these women altogether
and save lives. Additionally, we hope to determine which types of breast cancer
preferentially metastasize to bone," Dr. Gralow added.
Who Can Join This Trial
Researchers will enroll 6,000 women aged 18 or over whose tumors have been
surgically removed and who are receiving, or will receive, standard adjuvant hormonal therapy, chemotherapy, or both. See the list
of eligibility criteria.
Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See
the list
of study contacts or call the NCI's Cancer Information Service toll free
at 1-800-4-CANCER (1-800-422-6237). The call is confidential.
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