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.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2021/07/034579
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.To evaluate impact of chosen covariates on DFS in patients with HER2 positive breast cancers who do not achieve pCR after NACT <br/ ><br>2.To evaluate the impact of chosen covariates on (OS) in patients with HER2 positive breast cancers who achieve pCR after NACT. <br/ ><br>3.To evaluate impact of chosen covariates on OS in patients with HER2 positive breast cancers who do not achieve pCR after NACT. <br/ ><br>4.To evaluate the impact of chosen covariates on the achievement of pCR in the collected dataset. <br/ ><br>Timepoint: 1 year from the date of starting treatment