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Clinical Trials/CTRI/2021/02/031588
CTRI/2021/02/031588
Recruiting
Phase 2

eoadjuvant Concurrent Chemo-radiation with Paclitaxel and Trastuzumab versus Neoadjuvant chemotherapy with trastuzumab followed by sequential radiation in locally advanced Her2 neu positive breast cancers: a phase 2 randomized controlled trial

Cancer Institute0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Cancer Institute
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • •1\.All female patients with Her2 positive LABC who are planned for CTRT with paclitaxel and trastuzumab as neoadjuvant modality of treatment after multi\-speciality board discussion.
  • •2\.The following stages as per AJCC TNM staging 8th edition will be considered as LABC (IIIA, IIIB and IIIC). Except for patients with T4a tumors (chest wall fixity).
  • •3\.Age between 18 to 65 years
  • •4\.Karnofsky performance status score \>\=70
  • •5\.Normal cardiac function with echocardiography showing Ejection Fraction (EF) \> 50%

Exclusion Criteria

  • •1\.Patients with metastatic disease
  • •2\.Patients with chest wall fixity of tumor, as they are not considered for surgery after completion of neoadjuvant treatment.
  • •3\.Inflammatory breast cancer.
  • •4\.Male breast cancer
  • •5\.Patients deemed inoperable at presentation due to factors like lymphedema, chest wall fixity or cutaneous nodules extending beyond the confines of the breast.
  • •6\.SGOT (AST) \> 2\.0 x upper limit of normal (ULN) and SGPT (ALT) \>2\.0 x ULN and Bilirubin \>1\.5 x ULN
  • •7\.Serum creatinine \> ULN
  • •8\.Patient has received prior radiotherapy to the affected breast
  • •9\.Patients with uncontrolled diabetes mellitus, hypertension or ischemic heart disease.
  • •10\.Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.

Outcomes

Primary Outcomes

Not specified

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