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Clinical Trials/CTRI/2024/03/063553
CTRI/2024/03/063553
Recruiting
未知

A Multicenter, Retrospective, Noninterventional Study to Determine thePrevalence of HER2-low, Clinical Characteristics, Treatment Patterns, andAssociated Outcomes in Patients Previously Identified With HER2 negativeLocally-advanced or Metastatic Breast Cancer Who Progressed on Systemic Anticancer Therapy - iRetroBC-HER2L Study

AstraZeneca Pharma India Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C509- Malignant neoplasm of breast of unspecified site

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Sponsor
AstraZeneca Pharma India Ltd
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Men or women, \=18 years of age at study entry
  • •2\. Provision of informed consent by the patient or next of kin/legal representative (for
  • •deceased patients at study entry, unless a waiver was granted) according to local
  • •regulations
  • •3\. Must have a histological or cytological confirmed previous diagnosis as HER2\-negative
  • •(IHC zero, 1\+, 2\+/ISH\-) locally\-advanced or mBC between 01 January 2019 and
  • •31 December 2022, regardless of HR status
  • •4\. Must have progressed on any systemic anticancer therapy (eg, ET, chemotherapy, CDK4/6
  • •inhibitor, targeted therapies other than anti\-HER2, or immunotherapy) in the metastatic
  • •setting with the availability of at least 12 months of follow\-up data (from the index date)

Exclusion Criteria

  • •1\. Have a history of other malignancies, other than basal cell carcinoma of the skin and
  • •squamous cell carcinoma of the skin until 3 years prior to diagnosis of locally\-advanced or
  • •2\. Patients with historical HER2 status of IHC 2\+/ISH\+ or 3\+, or HER2 amplified

Outcomes

Primary Outcomes

Not specified

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