Observing mutations in metastatic ER-positive breast cancer patients

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

This observational study aims to assess the prevalence of emerging ESR1 mutations in patients with metastatic ER-positive breast cancer through liquid biopsies. It involves two cohorts: one with prior therapies and one without, comparing their mutation status to baseline tissue profiling. The study utilizes next-generation sequencing (NGS) methodologies to analyze both liquid and tissue biopsies for specific genetic mutations. The goal is to understand how treatment influences mutation development in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Cohort 1:

* BC patients, male and female,
* 18 years old and older,
* Pre or post menopausal,
* With HR+ (ER and/or PR positive) and Her-2 negative (confirmed centrally),
* Locally advanced irresectable and/or metastatic disease
* Confirmation of HR and Her-2 status may be performed in the primary tumor or in the metastatic lesion (patients with discordant results may be included),
* Patients must be candidates to CDK4/6i therapy in combination with endocrine therapy in the first line setting (with or without ovarian suppression)
* Patients may have received one previous line of chemotherapy in the metastatic setting, but no endocrine therapy in the metastatic setting is allowed,
* Patients may have received chemotherapy in the neo/adjuvant setting,
* Patients may have received endocrine therapy (with or without ovarian suppression) in the neo/adjuvant setting,
* Patients may have received a CDK4/6i in the adjuvant setting, provided they are still candidates for CDK4/6i therapy in the metastatic setting,
* Patients must be able to undergo a liquid biopsy procedure before starting their first line treatment,
* All patients must fill and sign an informed consent form.

Cohort 2:

* BC patients,
* Male and female,
* 18 years old and older,
* pre or post menopausal,
* With HR+ (ER and/or PR positive) and Her-2 negative (confirmed centrally),
* Locally advanced irresectable and/or metastatic disease who have progressed on a CDK4/6i in combination with endocrine therapy (with or without ovarian suppression) in the first or second line setting,
* All other non-conflicting inclusion criteria for cohort 1 apply.

Cohort 3:

* BC Patients,
* Male and female,
* 18 years or older,
* pre- or post-menopausal,
* With HR+ (ER and/or PR positive), HER2-negative (centrally confirmed) locally advanced unresectable and/or metastatic disease,
* Confirmation of HR and HER2 status may be performed on the primary tumour or the metastatic lesion (patients with discordant results may be included),
* Patients must be on first-line hormonal therapy with an aromatase inhibitor plus a CDK4/6 inhibitor (with or without ovarian suppression) for at least 6 months,
* No clinical or radiological evidence of progressive disease,
* Patients may have received a prior line of chemotherapy in the metastatic setting; however, prior endocrine therapy in the metastatic setting is not permitted,
* Patients may have received chemotherapy in the neoadjuvant/adjuvant setting,
* Patients may have received endocrine therapy (with or without ovarian suppression) in the neoadjuvant/adjuvant setting,
* Patients may have received a CDK4/6 inhibitor in the adjuvant setting, provided they are still eligible for CDK4/6 inhibitor therapy in the metastatic setting,
* Patients must be able to undergo a liquid biopsy procedure before starting their first-line treatment,
* All patients must read and sign an Informed Consent Form.

Exclusion Criteria:

* Patients WITHOUT HR+ (ER- and/or PR-positive)/HER2-negative disease,
* Patients without radiological and/or pathological confirmation of locally unresectable and/or metastatic breast cancer,
* Patients who are NOT candidates for further systemic treatment following a diagnosis of metastatic disease or disease progression,
* Patients who have already started a CDK4/6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) for first-line metastatic disease (for Cohort 1);
* Patients who have already started a new line of treatment for metastatic disease following progression on a CDK4/6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) (for Cohort 2);
* Patients with any suspicion of clinical or radiological disease progression at the time of the first liquid biopsy collection (for Cohort 3),
* Patients who are NOT able to undergo a liquid biopsy procedure,
* Patients who are NOT able to provide informed consent.

Where it's running

• Research Site
  São Paulo, Brazil Recruiting
• Ensino E Terapia de Inovação Clínica Amo - Ética
  Salvador, Estado de Bahia, Brazil Not yet recruiting
• Irmandade Da Santa Casa de Misericórdia de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Not yet recruiting
• Fundação Antonio Prudente - A.C. Camargo Cancer Center
  São Paulo, Brazil Not yet recruiting
• Instituto D'Or de Pesquisa E Ensino - São Paulo
  São Paulo, Brazil Not yet recruiting
• Sociedade Beneficente Israelita Brasileira Hospital Albert Eisntein
  São Paulo, Brazil Not yet recruiting

Study contacts

• Principal investigator: Rodrigo Dienstmann — Oncoclínicas
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

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

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Personalized treatment after endocrine therapy failure in metastatic breast cancer

  The study tests whether using a patient’s fresh tumor sample to try different drugs outside the body can help pick the next therapy for hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on endocrine therapy.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07895160

• SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low metastatic breast cancer

  This phase II study tests whether adding SSGJ-612 to a HER2-targeted antibody-drug conjugate helps people with HR-positive, HER2-low or ultralow metastatic breast cancer.

  Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Co., LTD. · Guangzhou, Guangdong · NCT07757230

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer

  This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.

  Recruiting at 5 sites Phase 3 Daiichi Sankyo · Columbia, Maryland and 4 other locations · NCT07683754

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.