EUCTR2020-001651-40-DE
Active, not recruiting
Phase 1
An adaptive randomized neoadjuvant two arm trial in triple-negative breast cancer comparing a mono Atezolizumab window followed by a Atezolizumab - CTX therapy with Atezolizumab – CTX therapy (neoMono) - neoMono
DrugsTecentriq
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- palleos healthcare GmbH
- Enrollment
- 458
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Female and male patients, age at diagnosis 18 years and above
- •? Written informed consent prior to admission to this study
- •? Histologically confirmed unilateral primary invasive carcinoma of the breast
- •? Clinical T1c – T4d \*
- •? Stage N0 \- N3 until 21 patients (5%) with stage N3 are randomized, thereafter N0 \- N2
- •? TNBC defined by and confirmed by central pathology:
- •o ER negative (\< 10% positive cells in IHC) and PR negative (\< 10% positive cells on IHC)
- •o HER2 negative breast cancer:
- •? Either defined by IHC: ICH scores of 0 \- 1 or an ICH score of 2 in combination with a negative ISH
- •? Or defined by ISH: negative ISH
Exclusion Criteria
- •? Previous history of malign diseases, non\-melanoma skin cancer and carcinoma of the cervix are allowed if treated with curative intent
- •? Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of Paclitaxel, Carboplatin, Epirubicin, Cyclophosphamide or Atezolizumab
- •? Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol
- •? Concurrent treatment with other drugs that are contraindicating the use of the study drugs
- •? Existing pregnancy
- •? Breastfeeding
- •? Sequential breast cancer
- •? Concurrent treatment with other experimental drugs and participation in another clinical trial or clinical research project (except registry study) within 30 days prior to study entry
- •? Severe and relevant co\-morbidity that would interact with the application of cytotoxic agents or the participation in the study including but not confined to:
- •o Uncompensated chronic heart failure or systolic dysfunction (LVEF \< 55%, CHF NYHA classes II\-IV),
Outcomes
Primary Outcomes
Not specified
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