This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer.
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2 weeks in patients with ER+/HER2- breast cancer. Eligible subjects who provide informed consent will first receive a 2-week window-of-opportunity treatment with imlunestrant combined with abemaciclib, followed by a biopsy of the primary lesion to assess Ki67 at 2 weeks. If the Ki67 of the primary lesion after 2 weeks is \<7.4%, they will be randomized in a 1:1 ratio to either Imlunestrant plus abemaciclib or neoadjuvant chemotherapy. If the Ki67 of the primary lesion after 2 weeks is ≥7.4%, patients will be assigned to neoadjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
189
Imlunestrant (400 mg orally, once daily) combined with abemaciclib (150 mg orally, twice daily) for 24 weeks.
Epirubicin (90 mg/m², intravenous infusion) combined with cyclophosphamide (600 mg/m², intravenous infusion, every 2 weeks or 3 weeks, determined by investigators) for 4 cycles, followed by docetaxel (100 mg/m², intravenous infusion, every 3 weeks) for 4 cycles.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
ORR between Arm A and Arm B
Defined as the proportion of patients whose tumor shrinks by a certain amount and maintains that reduction for a certain time, including cases of complete response (CR) and partial response (PR). Tumor objective response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). Subjects must have measurable tumor lesions at baseline.
Time frame: Immediately after the surgery
pCR rate between Arm A and Arm B
Defined as achieving pCR (ypT0/is, ypN0) upon postoperative pathological assessment, meaning the absence of any residual invasive cancer in the pathological evaluation of hematoxylin and eosin-stained resected breast samples and all ipsilateral lymph node samples after completing neoadjuvant therapy and surgery.
Time frame: Immediately after the surgery
Relative changes of Ki67 index between Arm A and Arm B
Defined as the geometric mean percentage change in Ki67 index from baseline to post-surgery. For patients with no detectable invasive cancer in the primary site post-surgery, a Ki67 value of 0.01 will be used as a substitute.
Time frame: Immediately after the surgery
3-year EFS between Arm A and Arm B
Defined as the time from randomization to the first recorded relevant event. Relevant events include preoperative disease progression, postoperative disease recurrence or metastasis, contralateral invasive breast cancer, second primary invasive cancer, and death from any cause.
Time frame: Following surgery until Year 3
3-year OS between Arm A and Arm B
Defined as the time from randomization to death from any cause. For subjects still alive at the last follow-up, OS is censored at the last follow-up time.
Time frame: Following surgery until Year 3
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Adverse events assessed according to CTCAE v6.0 criteria
To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V6.0)
Time frame: Up to one year during follow-up