Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)1
Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.
This randomized phase III trial is trying to find out the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.
Eligibility criteria include the following:
- 18-75 years old
- Estrogen-receptor positive and/or progesterone-receptor positive tumor
- HER2/neu negative tumor
- Has undergone surgery to remove the tumor within the past 3 months
- No previous chemotherapy or radiation therapy for this cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. For more details about the eligibility requirements, please fill out MidMichigan's Clinical Trial Information Request Form (PDF, 35 KB), and the clinical trials nurse will contact you to determine your eligibility.
- After surgery, patients will be assigned to one of three treatment groups based on their Oncotype DX recurrence scores:
- Group one (Oncotype DX recurrence score < 11): Patients in this group will receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane by mouth for up to 5 years. Some patients will then continue to receive hormone therapy for an additional 5 years.
- Group two (Oncotype DX recurrence score 11-25): Patients in this group will be randomly assigned (have an equal chance of being placed) to receive either hormone therapy alone or combination chemotherapy and hormone therapy. The patients who receive combination chemotherapy will start receiving hormone therapy no more than 4 weeks after finishing combination chemotherapy. The same hormone therapies used in group one will be used. All patients will receive hormone therapy by mouth for up to 5 or 10 years as in group one.
- Group three (Oncotype DX recurrence score > 25): Patients in this group will receive combination chemotherapy followed by hormone therapy similar to the patients in group two who are assigned to receive both types of treatment.
- All patients who had breast-conserving surgery will also undergo radiation therapy.
- After finishing treatment, patients will be evaluated periodically for up to 20 years.
Clinical Trial Information Request Form (PDF, 35KB)
Back to Clinical Trials Page
1 Protocol information provided courtesy of the National Cancer Institute, www.cancer.gov.
This page last updated May 18, 2006.