QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer

Обзор

This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.

Вмешательства

• Диагностический тест CE-10-IVD
  Leftover tumor tissue from a routine biopsy will be sent for analysis.

Первичные конечные точки

• Real-World Objective Response Rate [Срок оценки: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months]

Вторичные конечные точки (4)

• Real-World Progression Free Survival [Срок оценки: from date of first dose of T-DXd to date of last dose of T-DXd for each.Up to 100 months]
• Real-World Progression Free Survival and Objective Response Rate by estrogen receptor expression [Срок оценки: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months]
• Threshold for HER2 QIF and/or mRNA levels [Срок оценки: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months]
• Association between combined mRNA + QIF and real-world Objective Response Rate [Срок оценки: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months]

Критерии участия

Критерии включения

• Women and men age > 18 years
• Metastatic breast cancer, histologically- confirmed. Any estrogen receptor (ER) status is allowed. ER status will be determined by local laboratory assessment utilizing ASCO/CAP guidelines.
• Primary and/or metastatic tumor with 1+ level of expression of HER2 by immunohistochemistry as determined by local laboratory assessment utilizing ASCO/CAP guidelines.
• Measurable disease by cross-sectional imaging at the start of treatment. Patients with measurable bone-only disease or active brain metastases are eligible.
• Archival tissue available for biomarker assessment. One specimen should be the most recent metastatic biopsy. If HER2 1+ status was determined on a different specimen (either primary or metastatic tissue), that specimen is also required. Samples obtained from bone metastases that were processed via decalcification methods are not eligible.
• Intention to initiate therapy with T-DXd (Enhertu) at FDA-approved dose and schedule as next line of therapy. If T-DXd was already initiated, patients must be registered within 30 days of initiation.
• Ability to provide informed consent

Критерии исключения

• Concurrent Her2-overexpressing metastatic breast cancer (as confirmed by a metastatic biopsy with IHC 3+ or IHC 2+ with FISH amplified as per standard ASCO/CAP guidelines)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 37 центров

• University of California San Francisco Medical Center — San Francisco
• Smilow Cancer Hospital-Derby Care Center — Derby
• Smilow Cancer Hospital Care Center — Fairfield
• Smilow Cancer Hospital at Glastonbury — Glastonbury
• Smilow Cancer Hospital Care Center at Greenwich — Greenwich
• Smilow Cancer Hospital Care Center — Guilford
• Smilow Cancer Hospital at Saint Francis — Hartford
• Yale-New Haven Hospital North Haven Medical Center — New Haven
• … и ещё 29 центров

Идентификаторы

NCT: NCT06551116 · UPCC 09124 · 855924

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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