Pyrotinib and Trastuzumab Combined With Dalpiciclib Versus Combined With Docetaxel in Advanced HER2-Positive Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 received at most one prior line of systemic therapy (including anti-HER2 treatment) in the advanced setting will be randomized 1:1 to either the experimental or control arm. Stratification factors include ER status and presence of visceral metastases. The primary endpoint is Progression-Free Survival (PFS). Key secondary endpoints include Overall Survival (OS), Objective Response Rate (ORR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR), safety, and patient-reported quality of life. Exploratory endpoints involve correlating circulating tumor cells (CTCs) and PAM50 molecular subtyping with survival outcomes. This study seeks to determine if the all-oral, chemotherapy-free combination is non-inferior to the standard chemo-containing regimen, potentially offering a less toxic and more convenient treatment option for patients with advanced HER2-positive breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony nowotwór piersi z przerzutami, wrażliwy na HER2 (potwierdzone badaniem patologicznym)
- •Znany status receptorów hormonalnych
- •Co najmniej jedno mierzalne ognisko nowotworu
- •Maksymalnie jedno poprzednie leczenie systemowe w stadium zaawansowanym
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Prawidłowe wyniki badań krwi i funkcji organów (liczba komórek, wątroba, nerki, serce)
- •Dobra wola udziału w badaniu i podpisana zgoda
✗ Disqualifies
- •Przerzuty do mózgu powodujące objawy lub przerzuty do opon mózgowych
- •Aktywne przerzuty do mózgu (chyba że bezobjawowe i stabilne przez co najmniej 4 tygodnie)
- •Problemy z połykaniem lub zaburzenia wchłaniania leków
- •Niekontrolowany płyn w jamie brzusznej lub opłucnej
- •Radioterapia, chemioterapia lub leczenie celowane w ciągu ostatnich 4 tygodni
- •Ciąża, karmienie piersią lub brak efektywnej antykoncepcji
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 29, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Fudan Cancer Hospital
Shanghai, China
Trial contact
Hongxia Wang Chief physician
Ting Li Associate chief physician
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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