OncoMatch/Clinical Trials/NCT05601440
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
Is NCT05601440 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: RP-6306 · Gemcitabine · Niraparib · Fulvestrant · RP-3500 · CFI-402257 · CFI-400945 · Sacituzumab govitecan — This study is being done to answer the following question: Can testing breast cancer for DNA abnormalities or "biomarkers" help predict which patients are most likely to be helped by certain treatments? The pre-study screening is being done to test a sample of blood (or tumour tissue) for biomarkers to see if patients can participate in the study
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER >10%)
ER >10%
Required: HER2 (ERBB2) wild-type (not HER2 overexpressing/amplified as per ASCO/CAP criteria)
not HER2 overexpressing/amplified as per ASCO/CAP criteria
Disease stage
Required: Stage IV
Metastatic disease required
advanced / metastatic breast cancer, ER >10% and not HER2 overexpressing/amplified as per ASCO/CAP criteria. Patients with locally advanced or inflammatory disease without distant metastases that is potentially resectable or treatable with curative intent are not eligible
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CDK4/6 inhibitor — first line for advanced/metastatic disease, in combination with endocrine therapy
objective disease progression demonstrated on (defined as while taking or within 8 weeks of the last dose) first line CDK4/6i + ET for MBC. Patients must have received at least 24 weeks of first line CDK4/6i + ET therapy
Cannot have received: cytotoxic chemotherapy
Exception: adjuvant/neoadjuvant setting allowed; not permitted in palliative setting
cytotoxic chemotherapy or antibody drug conjugates (ADC) in the palliative setting are not permissible
Cannot have received: antibody-drug conjugate
Exception: adjuvant/neoadjuvant setting allowed; not permitted in palliative setting
cytotoxic chemotherapy or antibody drug conjugates (ADC) in the palliative setting are not permissible
Lab requirements
Blood counts
Hemoglobin ≥90 g/L; Absolute neutrophils ≥ 1.5 x 10^9/L (1500/µL); Platelets ≥ 100 x 10^9/L (100 x 10^3/µL)
Kidney function
Serum creatinine ≤ 1.5 x ULN, Creatinine clearance ≥50 mL/min
Liver function
Bilirubin ≤ 1.5 x ULN; AST & ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if liver metastases)
Cardiac function
LVEF ≥ 50%
Hemoglobin ≥90 g/L; Absolute neutrophils ≥ 1.5 x 10^9/L (1500/µL); Platelets ≥ 100 x 10^9/L (100 x 10^3/µL); Bilirubin ≤ 1.5 x ULN; AST & ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if patient has liver metastases); Serum creatinine ≤ 1.5 x ULN, Creatinine clearance ≥50 mL/min; LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05601440 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytotoxic chemotherapy, antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages