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Trial Title: Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

NCT ID: NCT05512780

Condition: Solid Tumor

Conditions: Official terms:
Letrozole

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Dalpiciclib
Description: An exploratory study of a single-arm, open design All subjects enrolled will receive the following treatment: Dalpiciclib combined with Letrozole, 28 days as one cycle.
Arm group label: Dalpiciclib+ letrozole

Other name: Letrozole

Summary: This is a single-arm, open-label, exploratory clinical study

Detailed description: This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1. Postmenopausal women aged ≥18 years, the definition of postmenopausal: 1. the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or 2. Age <60, natural postmenopausal state (defined as the spontaneous cessation of regular menstruation for at least 12 consecutive months, without other pathological or physiological causes), E2 and FSH at the postmenopausal levels 2. All patients were estrogen receptor (ER) positive (>10%), HER2 -negative invasive breast cancer regardless of PR expression level. Immunohistochemistry (IHC) score of 0+, or 2+ confirmed by pathology laboratory and negative in situ hybridization (ISH) test (HER-2/CEP17 ratio <2.0); 3. Treatment-naive patients with stage Ⅱ-Ⅲ tumors whose tumor staging meets the criteria of the 8th edition of the American Joint Committee on Cancer (AJCC) Staging; Exclusion Criteria: - 1. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. Concurrently receiving any other anti-tumor therapy that those specified in the protocol; 3. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 4. Stage Ⅳ breast cancer;

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: September 10, 2022

Completion date: August 10, 2024

Lead sponsor:
Agency: Hebei Medical University Fourth Hospital
Agency class: Other

Source: Hebei Medical University Fourth Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05512780

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