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Clinical Trials/CTRI/2024/02/063118
CTRI/2024/02/063118
Not yet recruiting
Phase 3

PRe-operative ChemoTherapy versus Surgery first with peri-operative interventions in Early triple negative and HER2 enriched breast- an open label, phase 3, randomized controlled trial (PRaCTiSE) - PRaCTiSE

Tata Memorial Centre0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C509- Malignant neoplasm of breast of unspecified site

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Sponsor
Tata Memorial Centre
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Histologically proved breast carcinoma
  • •2\.Triple negative(ER, PgR, HER2\-neu) and HER2\-neu positive (ER/PgR \+/\-)
  • •3\.T1\-2 (excluding T1a), N0\-1 (non\-metastatic)
  • •4\. \> 18 years \< 65 years
  • •5\.ECOG 0\-1
  • •6\.Written informed consent
  • •7\.Fit for surgery or chemotherapy

Exclusion Criteria

  • •1\.Pregnant, lactating women
  • •2\.Previous h/o breast or any other non\-skin malignancy
  • •3\.Previous treatment for excision biopsy/other cancer.
  • •4\.History of allergy to Inj. Lignocaine

Outcomes

Primary Outcomes

Not specified

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