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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 ³.

Principal Investigators

Dr. Julie Gralow and Dr. Robert Livingston, SWOG ⁴; Dr. James Ingle, NCCTG ⁵; Dr. Carla Falkson, ECOG ⁶; Dr. Alexander Paterson, NSABP ⁷; Dr. Elizabeth Dees, CALGB ⁸; and Dr. Mark Clemons, NCIC Clinical Trials Group ⁹.

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 bisphosphonates—zoledronate 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 ¹⁰.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study contacts ¹¹ or call the NCI's Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237). The call is confidential.

Glossary Terms

Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

A drug or substance used to treat hypercalcemia (abnormally high blood calcium) and bone pain caused by some types of cancer. Forms of bisphosphonates are also used to treat osteoporosis and for bone imaging. Bisphosphonates inhibit a type of bone cell that breaks down bone. Also called diphosphonate.

Treatment with drugs that kill cancer cells.

Treatment that adds, blocks, or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body’s natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Also called endocrine therapy, hormone therapy, and hormone treatment.