Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Sur… (NCT00310180) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
United States, Australia, Canada10,273 participantsStarted 2006-04-07
Plain-language summary
This randomized phase III trial studies 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. 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, by stopping them from dividing, or by stopping them from spreading. 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment and meet the following criteria:
* ER and/or progesterone receptor (PR)-positive: Estrogen and/or progesterone receptor positive disease (as defined by local pathology laboratory)
* Negative axillary nodes: As assessed by a sentinel lymph node biopsy, an axillary dissection, or both, and as defined by the Sixth Edition of the American Joint Committee on Cancer (AJCC) staging criteria
* Tumor size 1.1-5.0 cm (or 5 mm-1.0 cm plus unfavorable histological features):
* Unfavorable features defined as intermediate or poor nuclear and/or histologic grade, or lymphovascular invasion
* NOTE: Definition of tumor size: The tumor size used for determination of eligibility is the pathologic tumor size, which is usually determined by the size of the tumor as measured by inspection of the gross specimen; if the tumor size is measured microscopically and the tumor includes ductal carcinoma in-situ, the measurement should include only the invasive component of the tumor
* The tumor must be human epidermal growth factor receptor 2 (Her2)/neu negative by either fluorescent in-situ hybridization (FISH) or immunohistochemistry (e.g. 0 or 1+ by DAKO Herceptest)
* The patient and physician must be agreeable to initiate standard chemotherapy and hormonal therapy as adjuvant therapy
* A tissue specimen from the primary breast cance…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1The TAILORx trial is specifically studying whether adding chemotherapy to hormone therapy actually improves disease-free survival for women with node-negative, hormone receptor-positive breast cancer like mine — given that this is a Phase 3 trial, what do the results so far suggest about whether chemotherapy would add any real benefit in my specific situation?
2This trial uses a genomic test score to help decide whether chemotherapy is needed on top of hormone therapy — is that kind of genomic testing something that would apply to my case, and what does my score suggest about my risk of recurrence?
3Since the trial is no longer enrolling patients but is still active, could my doctor access any published or interim findings from TAILORx that might inform my treatment plan right now, even if I can't join the study?
4The trial focuses on 5-year disease-free survival as its main measurement — how does that timeframe line up with my own treatment goals, and does my doctor think the hormone therapy alone arm would be sufficient for someone with my cancer stage?
5Given that this trial covers a range of stages from Stage IA up to Stage IIIB, how does my specific stage affect whether the TAILORx findings are most relevant to my case, or would my doctor recommend a different approach based on where I fall in that range?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
5-year Disease-free Survival
Timeframe: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years