Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early 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
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early breast cancer. All patients initially receive induction treatment with fovinaciclib plus endocrine therapy and HER2-targeted therapy, followed by early assessment of treatment response after 6 weeks of treatment. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to standard neoadjuvant chemotherapy combined with HER2-targeted therapy prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and reduce unnecessary chemotherapy exposure.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku od 18 do 75 lat.
- •Rak piersi potwierdzony w badaniu histopatologicznym, z cechami HR-dodatniego i HER2-dodatniego.
- •Rak we wczesnym stadium lub miejscowo zaawansowany (stadium I-III wg systemu AJCC).
- •Pacjentki przed menopauzą muszą otrzymywać terapię hamującą czynność jajników.
- •Stan ogólny pacjentki dobry (grupa 0-1 wg skali ECOG).
- •Możliwość połykania kapsułek.
- •Prawidłowe wyniki badań krwi i narządów, np. liczba białych krwinek, płytek krwi, funkcje wątroby i nerek.
✗ Disqualifies
- •Udział w innym badaniu klinicznym lub leczenie, które może wpłynąć na wyniki tego badania.
- •Rak obu piersi, rak zapalny piersi lub rak piersi ukryty.
- •Choroby neurologiczne, np. niekontrolowane napady padaczkowe.
- •Inne choroby nowotworowe w ciągu ostatnich 5 lat.
- •Kobiety w ciąży lub karmiące piersią.
- •Ciężka nadwrażliwość na którykolwiek składnik leków stosowanych w badaniu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- June 1, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (3)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
2nd Affiliated Hospital, School of Medicine
Hangzhou, China
Ningbo No. 2 Hospital
Ningbo, China
Trial contact
Yunxiang Zhou
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.