The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.
The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.
About the trial
The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku co najmniej 20 lat
- •Potwierdzony nowotwór piersi wrażliwy na hormony (receptor estrogenowy i/lub progesteronowy dodatni)
- •Zaawansowanie raka II lub III stopnia
- •Prawidłowe funkcjonowanie organów wewnętrznych
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG 0-1)
✗ Disqualifies
- •Kobieta w ciąży lub karmiąca piersią
- •Kobieta w wieku rozrodczym bez stosowania skutecznej antykoncepcji przez czas badania i 12 miesięcy po jego zakończeniu
- •Aktywne infekcje, AIDS lub dodatni test HIV
- •Inne choroby lub stany, które mogłyby utrudnić udział w badaniu lub współpracę
Simplified criteria — AI translation
Trial details
- Minimum age
- 20 Years
- Last updated (source)
- March 16, 2023
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan
Department of Oncology,National Taiwan University Hospital
Taipei, Taiwan
Trial contact
Yen-Shen Lu, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.