Neoadjuvant Dalpiciclib Plus Letrozole for HR+/HER2- Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: dalpiciclib plus letrozole

• Registration Number: NCT05512416
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

In this single arm, open label, phase 2 trial, operable patients with stage IIB-III HR+/HER2- breast cancer will be enrolled and receive six cycles of adjuvant dalpiciclib plus letrozole. This study aims to assessed the biological effects and safety of dalpiciclib in combination with letrozole for HR+/HER2- breast cancer in the neoadjuvant setting.

Detailed Description

This is a single arm, open label, phase 2 trial aimed to investigate the biological effects and safety of neoadjuvant dalpiciclib in combination with letrozole for HR+/HER2- breast cancer. A total of 35 patients with stage IIB-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated. In each cycle, patients use dalpiciclib orally, 150mg, day 1-21, and letrozole orally, 2.5 mg, day 1-28. Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists. The primary endpoint is complete cell-cycle arrest at C1D15, defined as ki67≤2.7%. The secondary endpoints include residual cancer burden, overall response rate, change in Ki67 from baseline to 2 weeks of treatment, preoperative endocrine prognostic index, pathologic complete response, breast-conserving surgery rate and safety profile.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-21
• Last Update Submitted: 2022-08-21
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23
• Primary Completion: 2023-08
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cohort 1	dalpiciclib plus letrozole	patients with stage IIB-III HR+/HER2- breast cancer

Primary Outcome Measures

Name	Time	Method
Complete cell-cycle arrest at C1D15, defined as ki67≤2.7%	up 2 years	From the date into this study(signed ICF) to C1D15,defined as ki67≤2.7%

Secondary Outcome Measures

Name	Time	Method
residual cancer burden	up 2 years	The percentage of residual tumors after neoadjuvant therapy is assessed according to breast tumor bed tumors and regional lymph nodes
objective response rate	up 2 years	The rate of CR and PR,determined using RECIST v1.1 criteria
change in Ki67 from baseline to 2 weeks of treatment	up 2 years	change in Ki67 from baseline（From the date into this study(signed ICF) ） to 2 weeks of treatment
preoperative endocrine prognostic index	up 2 years	Prognostic indicators of preoperative endocrine therapy, including mass size after neoadjuvant endocrine therapy, lymph node status, ki67 levels, and estrogen receptor (ER) status
pathologic complete response	up 2 years	After neoadjuvant therapy, there are no residual invasive tumors in the primary focus and regional lymph nodes of breast cancer, but ductal carcinoma in situ may be present(ypT0/is ypN0)
breast-conserving surgery rate	up 2 years	The number of cases that actually underwent breast-conserving surgery after surgery accounted for the percentage of all breast cancer patients who underwent surgery
safety profile	up 2 years	Adverse events (AE) and severe adverse events (SAEs) are recorded. Refer to NCI-CTC AE 5.0 standard