Pyrotinib and Trastuzumab Combined With Dalpiciclib Versus Combined With Docetaxel in Advanced HER2-Positive Breast Cancer

The DIAMOND study (DIAMOND-01) is a multicenter, randomized, open-label, non-inferiority Phase III clinical trial conducted by Fudan University Shanghai Cancer Center. The study aims to evaluate the efficacy and safety of an oral, "non-intravenous" regimen (pyrotinib + trastuzumab \[subcutaneous\] + dalpiciclib) compared to a standard intravenous chemotherapy-containing regimen (pyrotinib + trastuzumab \[subcutaneous\] + docetaxel) in patients with advanced HER2-positive breast cancer. Approximately 502 patients with histologically confirmed advanced HER2-positive breast cancer who have recei

Trial Details

NCT ID

NCT07615751

Phase

PHASE3

Sponsor

Fudan University

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

Pyrotinib 320mg po qd d1-d21 q3w and Trastuzumab 600mg IH d1 q3w Combined with Dalpicicli 125mg po gd d1-d21 q4w
Pyrotinib 320mg po qd d1-d21 q3w and Trastuzumab 600mg IH d1 q3w Combined with Docetaxel 75mg/m² ivgtt d1 q3w,

Locations (sample)

Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

Age ≥ 18 years.
Patients with histopathologically confirmed recurrent/metastatic breast cancer that is HER2-positive (HER2 positivity is defined as IHC 3+, or IHC …
Hormone receptor status is known, based on the most recent pathological report.
At least one measurable lesion meeting RECIST 1.1 criteria.

For full eligibility, visit ClinicalTrials.gov.

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