OncoMatch/Clinical Trials/NCT07088263
Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer
Is NCT07088263 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Gemcitabine, Vinorelbine, Eribulin, or Utidelone for breast neoplasms.
Treatment: Gemcitabine, Vinorelbine, Eribulin, or Utidelone — The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of advanced breast cancer progressive after standard treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (IHC 0 or 1+, or IHC 2+ with negative ISH) (IHC 0 or 1+, or IHC 2+ with negative ISH)
HER2 negativity is defined according to the ASCO-CAP HER2 guidelines: IHC intensity of 0 or 1+, or IHC intensity of 2+ with negative in situ hybridization results
Allowed: ESR1 expression in ≥1% of tumor cells by IHC
HR positivity is defined as ER and/or PR expression in ≥1% of tumor cells by IHC
Allowed: PR (PGR) expression in ≥1% of tumor cells by IHC
HR positivity is defined as ER and/or PR expression in ≥1% of tumor cells by IHC
Allowed: BRCA1 germline mutation
germline BRCA mutations
Allowed: BRCA2 germline mutation
germline BRCA mutations
Disease stage
Metastatic disease required
advanced invasive breast cancer; at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — metastatic
Previous failure of first-line treatment for metastatic disease. For HR+/HER2- patients: at least received endocrine therapy combined with CDK4/6 inhibitors.
Must have received: CDK4/6 inhibitor — metastatic
Previous failure of first-line treatment for metastatic disease. For HR+/HER2- patients: at least received endocrine therapy combined with CDK4/6 inhibitors.
Must have received: chemotherapy — metastatic
TNBC patients at least received chemotherapy combined with PD-1 inhibitors (if PD-L1 CPS ≥1), or PARP inhibitor treatment (if germline BRCA mutations), except for TNBC patients with known germline BRCA mutations whom the attending physician deems them unable or unsuitable for PARP inhibitor treatment.
Lab requirements
Blood counts
adequate bone marrow function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Cardiac function
adequate cardiac reserve
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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