CompletedPhase IIFemale onlyEN originalBreast cancerTriple negative (TNBC)

A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer

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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.

RecruitingPhase III🇵🇱 PolandBreast cancerHormone receptor positive (HR+)

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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