TerminatedPhase 3

Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Stopped: Poor recruitement

Denmark123 participantsStarted 2009-05

Plain-language summary

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Who can participate

Age range

60 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: * Informed consent * Age 60 years or older * Measurable non-metastatic and non-inflammatory breast cancer * Tumor of 2 cm or larger * ER and/or PgR positive tumor * Co-morbidity index 0 - 3, e.g., no other serious medical condition Exclusion Criteria: * Prior medical therapy for a malignant disease, including aromatase inhibitors * Distant metastasis * Need for chemotherapy * Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri) * Treatment with a non-approved drug within 30 days

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

pCR

Timeframe: At four months

Clinical tumor response

Timeframe: At four months

Trial details

NCT IDNCT00908531

SponsorDanish Breast Cancer Cooperative Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12-01

View on ClinicalTrials.gov More Operable Breast Neoplasms trials