The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment

Официальное название

A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

Обзор

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer. This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

Вмешательства

• Препарат Ribociclib; abemaciclib; palbociclib; Dalpiciclib
  Neoadjuvant therapy: CDK4/6 inhibitor combined with endocrine, a total of 6 cycles, 1 cycle every 28 days. CDK4/6 inhibitors (choose one of the following four types): * Dalpiciclib 125 mg orally once a day d1-21 every 28 days for a cycle (3 weeks/1 week off) * Palbociclib 125 mg orally once a day, d1-21, every 28 days in cycles (3 weeks/1 week off) * Abemaciclib 150 mg orally twice daily in 28-day cycles (may be reduced to 100 mg orally twice daily if not tolerated) * Ribociclib 400 mg orally

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: At the end of Cycle 6 (each cycle is 28 days)]

Вторичные конечные точки (4)

• Ki67 variations [Срок оценки: At the end of Cycle 2(each cycle is 28 days)]
• complete cell cycle arrest (CCCA; Ki67 ≤ 2.7%) [Срок оценки: 6 months]
• iDFS [Срок оценки: 2 years]
• QoL [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age ≥ 18 years old.
• Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).
• Patients must have histologically confirmed ER and/or PR >10%, HER2-, early invasive breast cancer.
• Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases.
• ECOG PS score 0-2.
• Patients must be able and willing to swallow and retain oral medications.
• Premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test.
• Patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy.
• Absolute neutrophil count ≥ 1500/µL, platelet ≥ 100000/mm3, hemoglobin ≥ 10g/dL

Критерии исключения

• Prior treatment with any CDK inhibitor.
• Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.
• History of anaphylaxis caused by chemical or biologic components similar to dalsily.
• Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
• Uncontrolled intercurrent illness that would limit compliance with study requirements.
• Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission.
• Patients with any history of malignancy are not eligible.
• Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06810492 · HBCHBCC011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗