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EstroTEP and circulating biomarkers for ER-positive HER2-negative metastatic breast cancer patients
EU CTIS ID: 2023-506282-66-00
What this study is testing
To assess the efficacy of chemotherapy (Arm B) versus endocrine therapy (Arm C) as post-CDK4/6 inhibitor second line therapy in ER+ HER2- metastatic breast cancer patients displaying either unfavorable 18F-FES PET/CT features and/or high circulating markers
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Metastatic invasive breast carcinoma of no special type
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations.
- Signed informed consent.
- Patient affiliated to a social security system.
- Females of age ≥18 years.
- Life expectancy > 3 months.
You likely can't join if
- Other breast cancer subtype (e.g. invasive lobular breast carcinoma).
- History of previous cancer or hematological malignancy within 3 years preceding patient enrollment in the trial. Multiple primary breast cancers (controlateral/ipsilateral cancers/local relapses) are allowed pending all tumors were ER+ HER2-.
- Persons deprived of their freedom or under guardianship or incapable of giving consent.
- One or more prior line of chemotherapy in the metastatic setting.
- Any other antineoplastic therapy given at metastatic disease than the first line therapy with aromatase inhibitor and CDK4/6 inhibitor.
- Visceral crisis, per investigator’s assessment.
See the full eligibility criteria
- Metastatic invasive breast carcinoma of no special type
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including screening evaluations.
- Signed informed consent.
- Patient affiliated to a social security system.
- Females of age ≥18 years.
- Life expectancy > 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Estrogen Receptor (ER)-positive (≥10%) and HER2-negative (ASCO/CAP guidelines) breast cancer, per local assessment on the most recent breast cancer tissue examined.
- Tumor block FFPE (primary tumor or metastasis) available.
- Patients whose disease has progressed on first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor and who are deemed eligible, per investigator assessment, to a second line endocrine therapy. The progression on first line endocrine therapy with aromatase inhibitor and CDK4/6 inhibitor must have occurred after more than 6 months on treatment.
- Patients with available 18F-FDG PET/CT imaging
- Evaluable disease per RECIST criteria and measurable disease per PERCIST criteria.
- Other breast cancer subtype (e.g. invasive lobular breast carcinoma).
- History of previous cancer or hematological malignancy within 3 years preceding patient enrollment in the trial. Multiple primary breast cancers (controlateral/ipsilateral cancers/local relapses) are allowed pending all tumors were ER+ HER2-.
- Persons deprived of their freedom or under guardianship or incapable of giving consent.
- One or more prior line of chemotherapy in the metastatic setting.
- Any other antineoplastic therapy given at metastatic disease than the first line therapy with aromatase inhibitor and CDK4/6 inhibitor.
- Visceral crisis, per investigator’s assessment.
- Liver-only metastases.
- Prior exposure to any authorized or experimental agent degrading the estrogen receptor (fulvestrant, oral SERDs, PROTAC, etc).
- Pregnancy or lactation period.
- In women of childbearing potential or premenopausal women or women with amenorrhea of less than 12 months, without adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization; LHRH agonist cannot be considered as an efficient contraceptive measure), positive urinary or serum pregnancy test 72 hours before 18F-FES PET/CT.
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. Patients with a history of CNS metastases or cord compression are eligible if they have been treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable and off anticonvulsants and steroids for at least 4 weeks before treatment start.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.