A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)

Официальное название

A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy

Обзор

The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.

Вмешательства

• Препарат Giredestrant
  Participants will receive giredestrant at a dose of 30 mg orally once daily on Days 1-28 of each 28-day cycle for up to 4.5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Первичные конечные точки

• Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months [Срок оценки: At 12 months]
• Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0) [Срок оценки: From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months)]

Вторичные конечные точки (7)

• Percentage of Participants Achieving an Improvement in Individual Endocrine Therapy-specific Symptoms at 6 and 12 Months, Using the FACT-ES Questionnaire [Срок оценки: Baseline, 6 and 12 months]
• Percentage of Participants Categorized as Improved, Stable, or Worsening in Endocrine Therapy-specific Symptom Burden at 6 and 12 Months, Using the FACT-ES Questionnaire [Срок оценки: Baseline, 6 and 12 months]
• Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-related Burden at 6 and 12 Months, Using the BPI-SF Questionnaire [Срок оценки: Baseline, 6 and 12 months]
• Percentage of Participants Achieving an Improvement in Global Treatment Bother at 6 and 12 Months, Using the FACT-ES Questionnaire's GP5 Item [Срок оценки: Baseline, 6 and 12 months]
• Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Physical Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire [Срок оценки: Baseline, 6 and 12 months]
• Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Functional Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire [Срок оценки: Baseline, 6 and 12 months]
• Percentage of Participants Categorized as Improved, Stable, or Worsened in Global Health-Related Quality of Life (HRQoL) at 6 and 12 Months, Using the FACT-ES Questionnaire [Срок оценки: Baseline, 6 and 12 months]

Критерии участия

Критерии включения

• Considered appropriate for treatment with endocrine therapy (ET)
• Histologically confirmed diagnosis of ER+/HER2-, Stage I-III (low-/medium-/high-risk) early breast cancer (eBC)
• Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive
• Documented HER2- tumor according to ASCO/CAP
• Postmenopausal females at the time of signing the Informed Consent Form
• Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months
• Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent
• Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment
• Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance
• Participant and investigator planning the first switch from an AI
• Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and/or axillary lymph nodes dissection (ALND) and/or sentinel lymph node biopsy (SLNB) and/or radiotherapy
• Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1

Критерии исключения

• Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents
• Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease
• Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)
• Have active cardiac disease or history of cardiac dysfunction
• Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \[HBV\] or hepatitis C virus \[HCV\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
• Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
• Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Orange Coast Medical Center — Fountain Valley

Идентификаторы

NCT: NCT07541079 · GO46747

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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