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

Sponsor
Hongmei Zheng, PhD
Study ID
NCT06810492
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Stage II
  • Breast Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib; abemaciclib; palbociclib; Dalpiciclib — DRUG
    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 once a day in a 28-day cycle Endocrine therapy drugs: take according to the label. Premenopausal patients need to be treated for ovarian function suppression.

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Dec 2024
Primary completion
Dec 30, 2025
Completion
Dec 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HR+/HER2- breast cancer patients who are intolerance or insensitivity to neoadjuvant chemotherapy
    1. Age ≥ 18 years old. 2. 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). 3. 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. 4. ECOG PS score 0-2

Primary Outcome Measure

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

Central Contacts

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