Breast Cancer Foundation NZ
BGB-43395-101
Advanced Breast Cancer clinical trials for ER+
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works alone or in combination with fulvestrant, letrozole, or elacestrant in patients with advanced HR+/HER2- breast cancer (BC).
The main purpose of this study is to explore the recommended dosing for BGB-43395.
This is a phase 1a/1b study investigating the safety, tolerability, pharmacokinetics (how the drug behaves in your body), pharmacodynamics (how your body responds to the drug), and early signs of effectiveness of BGB-43395 (a CDK4 inhibitor), given alone or as part of combination therapies in patients with advanced HR+/HER2- breast cancer.
Inclusion Criteria:
- Phase 1a (Dose Escalation) and 1b (Dose Expansion): patients with advanced (metastatic) HR+/HER2- breast cancer.
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
- Adequate organ function without symptomatic visceral disease.
- Received prior therapy for their condition (if available) and should be refractory to, or intolerant of standard-of-care therapies:
- Phase 1a:
- must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.
- for combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.
- Phase 1b:
- must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease.
- Phase 1a:
Exclusion criteria also apply. Talk to your doctor or study site for details.
The trial will also be looking at the use of this drug in patients with other types of advanced solid tumours.
New Zealand
Christchurch: NZCR
Australia
QLD
SA
VIC
If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.
Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz
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