Metastatic Breast CancerPangeia-2NCT06417801
Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 6 sites in Brazil.
Trial summary
Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase inhibitor plus CDK4/6 inhibitor therapy) in comparison with patient's baseline ESR1 mutation… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 170 participants
- Where
- 6 sitesBrazil
- Study dates
- 17 Jun 2024to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3 parallel cohorts: 1. Locally advanced/metastatic HR-positive/HER2-negative breast cancer, either treatment-naïve or having previously received adjuvant therapy, without prior palliative therapy, eligible for first-line hormonal therapy, with primary tumour tissue available; 2. Locally advanced/metastatic HR+/HER2- breast cancer, progression during treatment with hormone therapy plus a CDK inhibitor; with primary tumour tissue available; 3. Locally advanced/metastatic HR+/HER2- breast cancer, with no disease progression during 6 months of hormonal therapy plus a CDK4/6 inhibitor; with archived tumour tissue available. Patients will be enrolled from the start of therapy with AI plus CDK4/6i in the metastatic setting (index date) up to 6 months into this first-line therapy, provided they have no clinical or radiological evidence of progressive disease. Patients will be followed up until disease progression.
Who may be able to join
- 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
Show all 37Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
6 sites in 1 country
Brazil6 sites, 6 recruiting
- Not yet recruiting
Irmandade Da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
- Not yet recruiting
Ensino E Terapia de Inovação Clínica Amo - Ética
Salvador, Estado de Bahia, 41.950-640
- Not yet recruiting
Fundação Antonio Prudente - A.C. Camargo Cancer Center
São Paulo, 01.509-900
- Not yet recruiting
Instituto D'Or de Pesquisa E Ensino - São Paulo
São Paulo, 01401-002
- Recruiting
Research Site
São Paulo, 04513-020
- Not yet recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Eisntein
São Paulo, 05652-000
About this study
Official title: Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer, With and Without Prior Therapies inMetastatic Setting, and During First-line Aromatase InhibitorPlus CDK4/6 Inhibitor Therapy, in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.
Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase inhibitor plus CDK4/6 inhibitor therapy) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling.
Read the detailed description
This is a prospective minimally interventional biomarker cohort study.
Biomarkers:
- GS Focus Liquid Breast (liquid biopsy sequencing test, covering mutations in ESR1, PIK3CA, AKT1, PTEN, ERBB2, BRCA1, BRCA2, PALB2);
- GS Focus Breast (tissue sequencing assay performed on basal tissue biopsy from the primary tumour or metastatic lesion not exposed to any systemic therapy, covering the same gene panel);
- ESR1 mutation by πCode (PlexBioTM), which covers hotspot variants (K303R, E380Q, S463P, P535H, L536P, L536H, L536Q, L536R, Y537S, Y537N, Y537C and D538G), with analytical sensitivity ranging from 0.1% to 0.5%, depending on the variant;
- PTEN analysis by IHC (VENTANA SP218). Biomarker assessment will be carried out by NGS methodology in both liquid biopsy and baseline tissue biopsy. Both strategies consider a custom panel covering PIK3CA, AKT1, PTEN, ESR1, BRCA1, BRCA2, PALB2, ERBB2 genes.
NGS panels were internally validated and presented sensitivity, specificity and accuracy of 100,00% with a limit of detection of 0,5% VAF for liquid biopsy panel and sensitivity, specificity and accuracy of 100,00% with a limit of detection of 5% VAF for tissue panel.
Cohort 3 will be recruited in two phases. The pilot phase will include 30 patients to assess the complexity of recruitment, sample logistics and laboratory operations using the new πCode liquid biopsy assay. If approved by the investigators and the sponsor, recruitment will continue with a further 70 patients for full-scale implementation.
For the detection of ESR1 mutations in Cohort 3, πCode microdisc technology (PlexBio™) will be used with the IntelliPlex™ ESR1 Mutation cfDNA Kit. This assay covers hotspot mutations in ESR1 in exons 4, 5, 7 and 8 (12 variants), with a DNA input of 10 ng and a detection limit ranging from 0.1% to 0.5%.
In Cohort 3, an initial liquid biopsy NGS assay (GS Focus Liquid) will be collected 6 months after the start of treatment, followed by ctDNA analyses using GS Focus Liquid and the πCode assay every 3 months for each patient, provided there is no evidence of clinical/radiological progression or the emergence of an ESR1 mutation. In parallel, if archived paraffin blocks are available, tissue NGS (GS Focus) and PTEN IHC (see below) will be performed to assess alterations present in primary tissue or metastatic lesions prior to exposure to AI plus CDK4/6i.
PTEN IHC will be analyzed in samples from prospective cohorts 1, 2, and 3 with valid NGS results from tissue and residual paraffin blocks. For PTEN staining by IHC, the VENTANA SP218 antibody will be used, which binds to the PTEN protein in FFPE sample sections (OptiView DAB IHC detection kit) run on the Roche-Ventana Benchmark Ultra platform, according to the manufacturer's instructions.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer; ER-positive; ESR-1 mutation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (N=30) | Locally-advanced/metastatic HR+/HER2- breast cancer, either treatment naive or previously exposed to adjuvant therapies, no prior palliative therapy, candidates to receive first-line hormone therapy, primary tumor tissue available. | |
| Cohot 2 (N=40) | Locally-advanced/metastatic HR+/HER2- breast cancer, progression during hormone therapy plus CDK inhibitor; primary tumor tissue available. | |
| Cohort 3 (N=100) | Locally advanced/metastatic HR+/HER2- breast cancer, with no disease progression during 6 months of hormonal therapy plus a CDK4/6 inhibitor; with archived tumour tissue available. Patients will be enrolled from the start of therapy with AI plus CDK4/6i in the metastatic setting (index date) up to 6 months into this first-line therapy, provided they have no clinical or radiological evidence of progressive disease. Patients will be followed up until disease progression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of emerging ESR1 mutations
Primary objective A (Cohorts 1 and 2): to determine the prevalence of emerging ESR1 mutations in liquid biopsy samples from two cohorts of breast cancer patients (with and without prior treatment in the metastatic setting) and to compare this with the baseline ESR1 mutation status as determined by the patient's tissue profile.
Primary objective B (Cohort 3): to determine the overall prevalence of emerging ESR1 mutations during first-line treatment with AI plus CDK4/6i in patients without clinical or radiological evidence of progressive disease, using a highly sensitive ctDNA assay.
Measured: Through study completation, an avarege 2 years
Secondary outcomes (1)
Define the prevalence of PIK3CA, AKT1, PTEN, BRCA1, BRCA2, PALB2, ERBB2 mutations.
To determine the prevalence of mutations in PIK3CA, AKT1, PTEN, BRCA1, BRCA2, PALB2 and ERBB2 in liquid biopsy samples and compare these with the patient's baseline status. To determine the prevalence of ESR1 mutations at different time points during treatment with AI plus CDK4/6i; to validate a highly sensitive and specific ctDNA assay for common ESR1 variants using πCode technology (PlexBioTM).
Measured: Through study completation, an avarege 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start17 Jun 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodrigo Dienstmann, Principal investigator, OncoclínicasVladmir C. de Lima, Principal investigator, FUNDAÇÃO ANTONIO PRUDENTE - A.C. CAMARGO CANCER CENTERTomas Reinert, Principal investigator, IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRERenata Bonadio, Principal investigator, INSTITUTO D'OR DE PESQUISA E ENSINO - SÃO PAULOMayana Lopes, Principal investigator, ENSINO E TERAPIA DE INOVAÇÃO CLÍNICA AMO - ÉTICALeandro Jonata C. de Oliveira, Principal investigator, SOCIEDADE BENEFICENTE ISRAELITA BRASILEIRA HOSPITAL ALBERT EISNTEIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417801
- Sponsor's protocol ID
- D3612L00003
- Acronym
- Pangeia-2
- Status last verified
- Oct 2026
- First submitted
- 13 May 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer, With and Without Prior Therapies inMetastatic Setting, and During First-line Aromatase InhibitorPlus CDK4/6 Inhibitor Therapy, in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.
- ClinicalTrials.gov ID
- NCT06417801
- Acronym / sponsor ID
- Pangeia-2 / D3612L00003
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer; ER-positive; ESR-1 mutation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase inhibitor plus CDK4/6 inhibitor therapy) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling.
Detailed description
This is a prospective minimally interventional biomarker cohort study.
Biomarkers:
- GS Focus Liquid Breast (liquid biopsy sequencing test, covering mutations in ESR1, PIK3CA, AKT1, PTEN, ERBB2, BRCA1, BRCA2, PALB2);
- GS Focus Breast (tissue sequencing assay performed on basal tissue biopsy from the primary tumour or metastatic lesion not exposed to any systemic therapy, covering the same gene panel);
- ESR1 mutation by πCode (PlexBioTM), which covers hotspot variants (K303R, E380Q, S463P, P535H, L536P, L536H, L536Q, L536R, Y537S, Y537N, Y537C and D538G), with analytical sensitivity ranging from 0.1% to 0.5%, depending on the variant;
- PTEN analysis by IHC (VENTANA SP218). Biomarker assessment will be carried out by NGS methodology in both liquid biopsy and baseline tissue biopsy. Both strategies consider a custom panel covering PIK3CA, AKT1, PTEN, ESR1, BRCA1, BRCA2, PALB2, ERBB2 genes.
NGS panels were internally validated and presented sensitivity, specificity and accuracy of 100,00% with a limit of detection of 0,5% VAF for liquid biopsy panel and sensitivity, specificity and accuracy of 100,00% with a limit of detection of 5% VAF for tissue panel.
Cohort 3 will be recruited in two phases. The pilot phase will include 30 patients to assess the complexity of recruitment, sample logistics and laboratory operations using the new πCode liquid biopsy assay. If approved by the investigators and the sponsor, recruitment will continue with a further 70 patients for full-scale implementation.
For the detection of ESR1 mutations in Cohort 3, πCode microdisc technology (PlexBio™) will be used with the IntelliPlex™ ESR1 Mutation cfDNA Kit. This assay covers hotspot mutations in ESR1 in exons 4, 5, 7 and 8 (12 variants), with a DNA input of 10 ng and a detection limit ranging from 0.1% to 0.5%.
In Cohort 3, an initial liquid biopsy NGS assay (GS Focus Liquid) will be collected 6 months after the start of treatment, followed by ctDNA analyses using GS Focus Liquid and the πCode assay every 3 months for each patient, provided there is no evidence of clinical/radiological progression or the emergence of an ESR1 mutation. In parallel, if archived paraffin blocks are available, tissue NGS (GS Focus) and PTEN IHC (see below) will be performed to assess alterations present in primary tissue or metastatic lesions prior to exposure to AI plus CDK4/6i.
PTEN IHC will be analyzed in samples from prospective cohorts 1, 2, and 3 with valid NGS results from tissue and residual paraffin blocks. For PTEN staining by IHC, the VENTANA SP218 antibody will be used, which binds to the PTEN protein in FFPE sample sections (OptiView DAB IHC detection kit) run on the Roche-Ventana Benchmark Ultra platform, according to the manufacturer's instructions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (N=30) | – | –Locally-advanced/metastatic HR+/HER2- breast cancer, either treatment naive or previously exposed to adjuvant therapies, no prior palliative therapy, candidates to receive first-line hormone therapy, primary tumor tissue available. |
| Cohot 2 (N=40) | – | –Locally-advanced/metastatic HR+/HER2- breast cancer, progression during hormone therapy plus CDK inhibitor; primary tumor tissue available. |
| Cohort 3 (N=100) | – | –Locally advanced/metastatic HR+/HER2- breast cancer, with no disease progression during 6 months of hormonal therapy plus a CDK4/6 inhibitor; with archived tumour tissue available. Patients will be enrolled from the start of therapy with AI plus CDK4/6i in the metastatic setting (index date) up to 6 months into this first-line therapy, provided they have no clinical or radiological evidence of progressive disease. Patients will be followed up until disease progression. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 parallel cohorts: 1. Locally advanced/metastatic HR-positive/HER2-negative breast cancer, either treatment-naïve or having previously received adjuvant therapy, without prior palliative therapy, eligible for first-line hormonal therapy, with primary tumour tissue available; 2. Locally advanced/metastatic HR+/HER2- breast cancer, progression during treatment with hormone therapy plus a CDK inhibitor; with primary tumour tissue available; 3. Locally advanced/metastatic HR+/HER2- breast cancer, with no disease progression during 6 months of hormonal therapy plus a CDK4/6 inhibitor; with archived tumour tissue available. Patients will be enrolled from the start of therapy with AI plus CDK4/6i in the metastatic setting (index date) up to 6 months into this first-line therapy, provided they have no clinical or radiological evidence of progressive disease. Patients will be followed up until disease progression.
Key inclusion criteria (37 listed)
- 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
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of emerging ESR1 mutations
Time frame: Through study completation, an avarege 2 years
Primary objective A (Cohorts 1 and 2): to determine the prevalence of emerging ESR1 mutations in liquid biopsy samples from two cohorts of breast cancer patients (with and without prior treatment in the metastatic setting) and to compare this with the baseline ESR1 mutation status as determined by the patient's tissue profile. Primary objective B (Cohort 3): to determine the overall prevalence of emerging ESR1 mutations during first-line treatment with AI plus CDK4/6i in patients without clinical or radiological evidence of progressive disease, using a highly sensitive ctDNA assay.
1 secondary outcome
Define the prevalence of PIK3CA, AKT1, PTEN, BRCA1, BRCA2, PALB2, ERBB2 mutations.
Time frame: Through study completation, an avarege 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Rodrigo Dienstmann principal investigator
Oncoclínicas
Vladmir C. de Lima principal investigator
FUNDAÇÃO ANTONIO PRUDENTE - A.C. CAMARGO CANCER CENTER
Tomas Reinert principal investigator
IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of emerging ESR1 mutations (time frame: Through study completation, an avarege 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.