Early Breast Cancer TreatmentParticipating in breast cancer clinical trials

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What are breast cancer clinical trials?

Clinical trials are a type of research study that tests how well medical approaches work in people. These studies test methods of screening, prevention, diagnosis, or treatment of a disease.

  • Clinical trials are the cornerstone of future advances in cancer therapies and help determine whether promising approaches to cancer prevention and treatment are safe and effective
  • Before you decide whether to enter a clinical trial, you should discuss your disease, diagnosis, and available treatment options with your physician
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Finding breast cancer clinical trials

The following Web sites may provide you with further information about clinical trials.


www.cancer.gov/clinical_trials
The "Clinical Trials" section of the National Cancer Institute Web site allows patients to search for clinical trial information.


www.clinicaltrials.gov
ClinicalTrials.gov is a service of the National Institutes of Health (a division of the US Department of Health and Human Services) developed by the National Library of Medicine that provides patients with regular updates about clinical trials, clinical trial locations, and eligibility for participation.


www.centerwatch.com
CenterWatch provides patients with information and educational materials about the clinical research industry.


www.emergingmed.com
EmergingMed.com is a free and confidential online service that helps match patients to clinical trials.

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Important Information About ARIMIDEX

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

Important Safety Information About ARIMIDEX

  • Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child
  • Based on information from a study in patients with early breast cancer, women with a history of blockages in heart arteries (ischemic heart disease) who take ARIMIDEX may have a slight increase in this type of heart disease compared to similar patients who take tamoxifen
  • ARIMIDEX can cause bone softening/weakening (osteoporosis) increasing the chance of fractures. In a clinical study in early breast cancer, there were more fractures (including fractures of the spine, hip, and wrist) with ARIMIDEX (10%) than with tamoxifen (7%)
  • In a clinical study in early breast cancer, some patients taking ARIMIDEX had an increase in cholesterol. Skin reactions, allergic reactions, and changes in blood tests of liver function have also been reported
  • In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms (including arthritis and arthralgia), weakness, mood changes, pain, back pain, sore throat, nausea and vomiting, rash, depression, high blood pressure, osteoporosis, fractures, swelling of arms/legs, insomnia, and headache
  • In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, headache, bone pain, increased cough, shortness of breath, sore throat, and swelling of arms and legs. Joint pain/stiffness has been reported in association with the use of ARIMIDEX
  • ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies

Please click here for full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).