OncoMatch/Clinical Trials/NCT05332561
Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)
Is NCT05332561 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for early-stage breast cancer.
Treatment: Atezolizumab 1200 mg in 20 ML · Inavolisib · Ipatasertib · Olaparib · Sacituzumab govitecan · Trastuzumab/pertuzumab — In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR). While this approach was exemplified in two phase III trials without biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by individualized genomic-guided post-neoadjuvant therapies. Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to reduce the substantial risk of local and distant relapse. The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials. Allocation to the therapy-arms is conducted by in depth molecular characterization of tumors within the COGNITION registry program. The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm. The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) positivity (IHC ≥1% on immune cells within the tumor) (IHC ≥1% on immune cells)
PD-L1 positivity measure by IHC (≥1% on immune cells within the tumor)
Required: PD-L1 (CD274) amplification
CD274 amplification
Required: PIK3CA known/reported oncogenic mutation
Known/reported oncogenic mutation in PIK3Ca
Required: AKT1 aberration predicting increased PI3K-AKT pathway activity except PI3K-mutations
Aberrations predicting increased PI3K-AKT pathway activity except PI3K-mutations
Required: BRCA1 inactivating somatic or germline mutation including homozygous deletions
Inactivating somatic or germline BRCA1/2 mutation including homozygous deletions
Required: BRCA2 inactivating somatic or germline mutation including homozygous deletions
Inactivating somatic or germline BRCA1/2 mutation including homozygous deletions
Required: PALB2 inactivating germline mutation
Inactivating germline PALB2 mutations
Required: TACSTD2 overexpression
Trop-2-overexpression (with IHC and except known/reported homozygous polymorphism in UGT1A1*28)
Required: HER2 (ERBB2) exon-20 insertion
HER2 exon-20 insertion
Required: HER2 (ERBB2) activating mutation
Activating HER2-mutation
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Conducted neoadjuvant chemotherapy
Must have received: surgery — post-neoadjuvant
conducted neoadjuvant chemotherapy and surgery
Must have received: post-neoadjuvant treatment — post-neoadjuvant
conducted standard post-neoadjuvant treatment +/- radiotherapy (standard according to German guidelines except Abemaciclib and Olaparib)
Lab requirements
Blood counts
adequate bone marrow function defined by laboratory tests
Kidney function
adequate renal function defined by laboratory tests
Liver function
adequate hepatic function defined by laboratory tests
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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 qualify