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Blood Biomarkers for Breast Cancer Treatment Response

Prospective Plasma Biomarker Study to Predict 2nd Line Endocrine Therapy Response in ER+ Metastatic Breast Cancer (TrackER)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 18 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study looks at whether a simple blood test can help predict how well a breast cancer treatment will work."
  • "Researchers collect a blood sample when patients start a second hormone therapy treatment and may collect additional samples over time."
  • "Participants will provide a blood sample before starting treatment, with optional additional samples collected during treatment or at disease progression."
  • "The study will be conducted across multiple sites within a single institution and will run for approximately 18 months, including a 12-month enrollment period and 6 months of follow-up."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether blood tests can help predict how well a second hormone treatment will work. It is for adults with breast cancer that uses hormones to grow, has spread to distant parts of the body, and has gotten worse during their first treatment.

This study looks at whether a simple blood test can help predict how well a breast cancer treatment will work. It follows patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment. Researchers collect a blood sample when patients start a second hormone therapy treatment and may collect additional samples over time. By comparing blood test results with patient outcomes, the study aims to identify biomarkers that can predict which patients are most likely to benefit from treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Breast cancer confirmed by a cell or tissue test that has spread to distant parts of the body (stage IV).
  • Cancer uses hormones to grow and has gotten worse during the first treatment.
  • Able to care for yourself and be out of bed or a chair for more than half of waking hours (ECOG score 0–2).
  • Local tests show the cancer is estrogen receptor-positive (ER-positive), meaning estrogen can help it grow.
  • Local tests show the cancer is HER2-negative, meaning it does not have high levels of the HER2 protein.
  • Have not had chemotherapy.
  • Able to understand and willing to sign a study consent form, and willing to give blood samples over time.

Who can't join

  • A health condition or life situation that could keep you from following the study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Patients must be ≥18 years of age 2. Cytologically or histologically confirmed invasive breast cancer that is: 1. Clinical stage IV 2. HR positive 3. Progressing on first line treatment 3. ECOG 0-2 4. Locally assessed ER+. 5. Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested). 6. No prior chemotherapy 7. Must have the ability to understand and the willingness to sign a written informed consent document. 8. Must be willing to provide serial blood samples for the study. Exclusion Criteria: 1\. Medical condition or social situation that may preclude adherence to the protocol.

Study sites (1)

PA