Treatment choices and outcomes for early luminal breast cancer patients eligible for EndoPredict testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PRELUDE is a prospective, multicenter, non-interventional registry enrolling up to 2,000 adults with ER-positive/HER2-negative (luminal) early breast cancer who are eligible for EndoPredict testing. Participants may or may not undergo the EndoPredict test, and will be followed once per year for up to 10 years after surgery to document treatments and clinical outcomes. The registry will compare 5- and 10-year outcomes by EndoPredict (EP/EPclin) risk groups and analyze how patient and tumor characteristics influence adjuvant treatment decisions in routine clinical practice. The study is planned at about 10–20 sites primarily in Greece, with the option to add sites elsewhere if needed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years old.
* Histological diagnosis of invasive breast cancer.
* T1-T3 tumor size.
* 0-3 positive axillary lymph nodes.
* Documented ER-positive tumor by immunohistochemistry (≥1% or Allred Score: ≥3/8 or H-score: ≥50/ 300)
* Documented HER2-negative tumor by immunohistochemistry and/or in situ hybridization
* Subject with signed and dated informed consent form.

Exclusion Criteria:

* History of another primary malignancy within the last 5 years, except for resected non-melanoma skin cancer.
* Pre-operative chemotherapy administered.
* Subject without signed and dated informed consent form.

Where it's running

• "Elena Venizelou" General Hospital, Department of Surgery
  Athens, Greece Recruiting
• "Prolipsis" Center, Breast Unit
  Athens, Greece Recruiting
• Henry Dunant Hospital Center, 3rd Breast Surgical Department
  Athens, Greece Recruiting
• Laiko Hospital, National and Kapodistrian University of Athens, Medical School
  Athens, Greece Recruiting
• Mediterraneo Hospital, Breast Clinic
  Athens, Greece Recruiting
• Metropolitan General Hospital, 3rd Breast Clinic
  Cholargós, Greece Recruiting

Study contacts

• Study coordinator: Michalis Kontos
• Email: michalis_kontos@yahoo.com
• Phone: +30 2132060800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Radiation therapy for inoperable breast cancer

  This trial will try adding a short, high-dose whole-breast radiation course with a focused boost to usual breast cancer medicines for people with locally advanced breast cancer who cannot or do not want surgery.

  Recruiting Stony Brook University · Stony Brook, New York · NCT07122713

• Predicting outcomes for advanced breast cancer patients treated with CDK4/6 inhibitors and endocrine therapy

  This study is trying to see how well different CDK4/6 inhibitors combined with hormone therapy work for people with advanced breast cancer and how safe they are.

  Recruiting at 24 sites Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Aviano and 23 other locations · NCT06805812

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.