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Not yet recruitingPhase 1

Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial

Pilot Study: Evaluation of Novel Data-Driven Outcomes Via Response-Guided Systems Medicine in Hormone Receptor-Positive Advanced Breast Cancer (ENDORSE)

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

  • Procedures mentioned: Blood draws, MRI scans, CT scans, Biopsies

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
  • "Patients undergo blood sample collection and computed tomography (CT) scan or magnetic resonance imaging (MRI) and/or bone scan and/or positron emission tomography (PET) scan throughout the study."
  • "Patients may undergo tumor biopsy during screening and may optionally undergo at progression."
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 a report based on tumor testing can help guide breast cancer treatment. It is for adults with hormone receptor-positive, HER2-negative breast cancer that cannot be removed by surgery or has spread, and has grown during or after hormone treatment. The report suggests medicines that may work and medicines the cancer may resist.

This clinical trial tests the feasibility and utility of a biology guided therapy recommendations report to aid in determining treatment of hormone receptor positive breast cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). The biology guided therapy recommendations report is developed from testing a patients tumor tissue when they have progression to see what medications may work best and what medications the cancer may be resistant to based on their tumor biology. Patients and their doctor then receive that report with the suggested treatments. Receiving a biology guided therapy recommendations report may be a feasible and useable way to aid in treatment determination for hormone receptor positive advanced, unresectable or metastatic breast cancer.

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

Eligibility

Who can join

  • You must be at least 18 years old and speak English.
  • You or your legal representative must give informed consent, meaning agreement after learning about the study.
  • You must agree to let researchers use stored tissue from earlier tumor biopsies. The study leader may allow an exception if no tissue is available.
  • A tissue test must confirm breast cancer that cannot be removed by surgery or has spread. It must be HER2-negative, with estrogen or progesterone receptors in at least 10% of cancer cells.
  • Your cancer must have grown during the first hormone treatment for advanced cancer, or during or within 2 years after CDK4/6 inhibitor treatment given after main treatment for early breast cancer.
  • You must be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • You must have at least one tumor area that can be sampled with a needle through the skin, and a biopsy must be medically suitable for you.

Who can't join

  • You have received any of these treatments for cancer that has spread: capecitabine; a PI3K, mTOR, or Akt inhibitor; a SERD; or HER2-targeted treatment, including neratinib. These are cancer medicines that act in different ways.
  • You have cancer in the brain or the tissues around the brain and spinal cord that the study team decides makes this treatment approach unsuitable.
  • You have a history of another cancer, except adequately treated non-melanoma skin cancer, cured early cervical cancer that had not spread, or other solid tumors that do not need active treatment.
  • You are expected to live less than 1 year.
  • You are pregnant or breastfeeding.
  • You have another condition that the study doctor believes would make study procedures unsafe for you.

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

Official eligibility criteria

Inclusion Criteria: * Participant must speak English * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Patients must have histologically confirmed, unresectable or metastatic hormone receptor positive, HER2 breast cancer. Hormone receptor positive is defined as estrogen receptor \>= 10% and/or progesterone receptor \>= 10%. Her2 negative per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines * Patient must have disease progression during or after prior endocrine therapy meeting one of the following criteria: * Disease progression on 1st line endocrine therapy for advanced/metastatic breast cancer. * Disease progression on or within 2 years of completion of treatment with a CDK4/6i in the adjuvant setting for early- stage breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Patient must have at least one lesion amenable to percutaneous core * Clinically appropriate for biopsy Exclusion Criteria: * Prior treatment in the metastatic setting with capecitabine, phosphoinositide 3 kinase (PI3K) inhibitor, mechanistic target of rapamycin (mTOR) inhibitor, protein kinase B (Akt) inhibitor, selective estrogen receptor degrader (SERD), or HER2-targeted therapy, including neratinib * Known or untreated, or active, brain or leptomeningeal metastases that are deemed inappropriate to pursue therapy guided by systems medicine approach. Enrolled patients may receive radiation or other loco regional therapy prior to initiating systemic therapy on study. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors not requiring active therapy * Life expectancy \< 1 year * Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Study sites (2)

CA