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Observational research to study the factors that can affect the outcome in patients who have HER2 positive breast cancer, who have received chemotherapy before surgery.

Retrospective observational study to determine factors influencing outcome in patients with Human Epidermal Growth Factor Receptor 2 positive breast cancers who receive neoadjuvant chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/034579
Enrollment
1000
Registered
2021-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Nil: Nil

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All individuals above 18 years of age with histologically confirmed HER2 positive breast cancers who received neoadjuvant chemotherapy during the period of January 2014 to December 2018. 2.Patients who have received even 1 cycle of treatment in the neoadjuvant setting will be included in the analysis. 3.Patients who have received one or more of the following treatments as part of neoadjuvant treatment will be included in the study: chemotherapy and/or HER2targeted therapy. 4.Patients with Stage 1 to Stage 3 breast cancer (AJCC 7th edition 2010) will be included in the analysis

Exclusion criteria

Exclusion criteria: 1.Individuals with HER2 positive breast cancers who did not receive neoadjuvant therapy for any reason 2.Upfront metastatic HER2 positive breast cancers 3.Individuals with other coexistent malignancies

Design outcomes

Primary

MeasureTime frame
To evaluate the impact of chosen covariates on disease free survival (DFS) in patients with HER2 positive breast cancers who achieve pathological complete response after neoadjuvant chemotherapy.Timepoint: 3 months

Secondary

MeasureTime frame
1.To evaluate impact of chosen covariates on DFS in patients with HER2 positive breast cancers who do not achieve pCR after NACT 2.To evaluate the impact of chosen covariates on (OS) in patients with HER2 positive breast cancers who achieve pCR after NACT. 3.To evaluate impact of chosen covariates on OS in patients with HER2 positive breast cancers who do not achieve pCR after NACT. 4.To evaluate the impact of chosen covariates on the achievement of pCR in the collected dataset. Timepoint: 1 year from the date of starting treatment

Countries

India

Contacts

Public ContactYogesh Kembhavi

Tata Memorial Centre

sudeepgupta04@yahoo.com02224177201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026