OncoMatch/Clinical Trials/NCT06793553
Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+ TNBC
Is NCT06793553 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Induction therapy for metastatic breast cancer.
Treatment: Induction therapy — The objective of this research is to evaluate the efficacy of the treatment strategy to administer atezolizumab + nab-paclitaxel (PTX) following 2 cycles of induction therapy with PTX + bevacizumab (induction treatment strategy) in programmed cell death ligand-1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) in comparison with the standard atezolizumab + nab-PTX therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) positivity (SP142 IC ≥ 1) (SP142 IC ≥ 1)
Documented PD-L1 positivity (SP142 IC ≥ 1) confirmed by local assessment of the most recent tumor sample or an archival tumor sample.
Required: ESR1 negative (< 10% positive cell occupancy or Allred Proportion score of 0-2) (< 10% positive cell occupancy or Allred Proportion score of 0-2)
ER-negative (< 10% positive cell occupancy or Allred Proportion score of 0-2)
Required: HER2 (ERBB2) negative (IHC 1+ or less or FISH/DISH negative) (IHC 1+ or less or FISH/DISH negative)
HER2-negative (IHC 1+ or less or FISH/DISH negative) according to ASCO/CAP Criteria 2018 (in the case of IHC2+, negativity is confirmed by FISH/DISH)
Disease stage
Required: Stage IV, UNRESECTABLE ADVANCED
Metastatic disease required
Diagnosed with metastatic recurrent or unresectable advanced TNBC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: prior treatment with PARP inhibitors for metastatic recurrent or unresectable advanced cancers in patients with pathogenic BRCA variants is allowed
Patients who have not received chemotherapy for metastatic recurrent or unresectable advanced cancer. However, prior treatment with PARP inhibitors for metastatic recurrent or unresectable advanced cancers in patients with pathogenic BRCA variants is allowed.
Cannot have received: radiation therapy
Exception: Administration or irradiation on the same day of the week 14 days prior to the day of enrollment is permitted.
Patients who have received radiotherapy within 14 days prior to enrollment.
Cannot have received: other study drugs
Exception: Administration on the same day of the week 14 days prior to the day of enrollment is permitted.
Patients who have received other study drugs within 14 days prior to enrollment.
Cannot have received: live vaccine
Exception: Administration of inactivated vaccines is permitted.
Administration of a live vaccine within 30 days of the first dose of the study drug.
Lab requirements
Blood counts
Neutrophil count ≥ 1500/mm3; Platelet count ≥ 10 x 10^4/mm3; Hemoglobin ≥ 8.0 g/dL
Kidney function
Creatinine ≤ 1.5 mg/dL; urine protein (dipstick) is negative (-) or 1+; if urine protein (dipstick) is ≥ 2+, 24-hour urine protein ≤ 1 g/24 hours or urine protein/creatinine ratio ≤ 1
Liver function
AST (GOT) ≤ 100 IU/L (≤ 200 IU/L if liver metastasis is present); ALT (GPT) ≤ 100 IU/L(≤ 200 IU/L if liver metastasis is present); Total bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL for Gilbert's syndrome)
Cardiac function
Blood pressure is sufficiently controlled (systolic ≤ 150 mmHg and diastolic ≤ 90 mmHg with ≤ 2 antihypertensive drugs); no significant cardiovascular disease (history of MI, acute coronary artery disease, coronary angioplasty/stenting/bypass grafting within last 6 months; CHF NYHA Class III-IV)
Laboratory tests performed within 14 days before enrollment meet the following criteria [1] to [8]... Blood pressure is sufficiently controlled (systolic blood pressure ≤ 150 mmHg and diastolic blood pressure ≤ 90 mmHg with ≤ 2 antihypertensive drugs [counted as the number of combinations]).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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