Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.
A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative 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.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
About the trial
This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat, płeć żeńska
- •Zrozumienie badania i chęć podpisania umowy uczestnika
- •Potwierdzony nowotwór piersi (bez receptorów HR i HER2) w stadium zaawansowanym lub nawracającym
- •Poprzednie leczenie systemowe: 1-2 linie (progresja w ciągu 12 miesięcy po leczeniu pomocniczym liczy się jako jedna linia)
- •Co najmniej jeden mierzalny guz según kryteriów RECIST 1.1
- •Ogólny stan zdrowia ECOG 0-1, bez pogorszenia w ostatnich dwóch tygodniach
- •Oczekiwana długość życia co najmniej 12 tygodni
- •Prawidłowe funkcje narządów: wystarczająca liczba neutrofili, płytek krwi, hemoglobiny oraz enzymów wątroby i nerek
✗ Disqualifies
- •Wcześniejsze leczenie gemcytabiną
- •Wcześniejsze leczenie karboplatyną w zaawansowanym raku piersi (dopuszczalne jeśli podane w leczeniu pomocniczym więcej niż 6 miesięcy przed nawrotem)
- •Przerzuty do mózgu lub opon mózgowych wymagające natychmiastowej radioterapii lub kortykosteroidów
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 18, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Hunan Cancer Hospital
Changsha, China
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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