CTRI/2023/05/052756
Not yet recruiting
Phase 2
A randomized, open-label, phase II study to evaluate the efficacy and safety of a novel dose-dense regimen of docetaxel-cyclophosphamide alternating with epirubicin-cisplatin compared to standard dose-dense anthracycline, taxane and cyclophosphamide as neoadjuvant chemotherapy in early and locally advanced TNBC. - NeoPlaNET
CMC Vellore0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CMC Vellore
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Documented histologically confirmed invasive ductal carcinoma of the breast
- •ECOG Performance Status 0\-2
- •Hormone Receptor Status should be documented as negative
- •HER2 documented negative
- •Stage I\-IIIC
Exclusion Criteria
- •Pregnant, breastfeeding
- •Multicentric or bilateral disease
- •neuropathy grade 2 or above
- •CCF NYHA class 3 or above
- •LV dysfunction
- •creatinine clearance less than 60 ml
Outcomes
Primary Outcomes
Not specified
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