Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Not applicable: Not applicable
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed invasive ductal carcinoma (IDC) breast, with the following specifications: - Age: 15 years and above - Females - Diagnosed between 1st January 2015 and 31st December 2020 - Estrogen receptor (ER) or Progesterone receptor (PR) positive by IHC - HER2 by IHC: Zero (0) or One plus (1+) or - HER2 by IHC: Two plus (2+) and HER-2 gene amplification by FISH: non-amplified
Exclusion criteria
Exclusion criteria: 1 Ductal carcinoma in-situ DCIS 2 Lobular carcinoma 3 Triple negative breast cancer ER, PR and HER2 negative by IHC 4 HER2 positive by IHC 5 HER2 by IHC: Two plus and HER2 gene amplification by FISH amplified equivocal uninterpretable or not done
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the overall survival in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm.Timepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the DFS in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm in the curative setting. 2. To evaluate the PFS in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm in the metastatic setting. 3. To evaluate the differences in the demographic profile in the HER2 low arm of hormone-positive breast cancer as compared to HER2 negative arm.Timepoint: 5 years | — |
Countries
India
Contacts
Public ContactYogesh Kembhavi
Tata Memorial Center
Outcome results
None listed