Prevalence of emerging treatment-induced mutations in metastatic ER-positive breast cancer. - Pangeia-2

Study identifier:D3612L00003

ClinicalTrials.gov identifier:NCT06417801

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

PANGEIA-2: Prevalence of emerging treatment-induced mutations in metastaticER positive breast cancer.

Medical condition

Metastatic Breast Cancer

Phase

Phase 4

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

Study type

Observational

Age

18 Years - 100 Years

Date

Study Start Date: 17 Jun 2024

Estimated Primary Completion Date: 30 Dec 2025

Estimated Study Completion Date: 30 Dec 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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), 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 felame, 18 years old and older, pre or post menopausal,
with HR+ (ER and/or PR positive), 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.

Exclusion Criteria

Patients with HR+ (ER and/or PR positive) and Her-2 negative disease NOT
confirmed centrally
• Patients with NO radiologic and/or pathologic confirmed locally irresectable
and/or metastatic breast cancer
• Patients who are NOT candidates for further systemic treatment after diagnosis
of metastatic disease or disease progression
• Patients who have already started a CDK4/6i in combination with endocrine
therapy (with or without ovarian suppression) for metastatic disease in the first
line setting (for cohort 1); and patients who have already started a new line of
treatment for metastatic disease after disease progression on a CDK4/6i in
combination with endocrine therapy (with or without ovarian suppression)(for
cohort 2)
• Patients who are NOT able to undergo a liquid biopsy procedure
• Patients who are NOT able to provide informed consent.

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No locations available

Arms	Assigned Interventions
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.	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Rodrigo Dienstmann

Oncoclínicas