Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with histologically confirmed locally advanced, hormone receptor-positive (ER+ and/or PR+), HER2-negative breast cancer. 2. Women not suitable for chemotherapy due to age, comorbidities, or personal preference. 3. Women with adequate organ function. 4. Women with ECOG performance status of 0-2
Exclusion criteria
Exclusion criteria: 1. Women with prior treatment for the current breast cancer diagnosis. 2. Women with bilateral breast cancer 3. Women with inflammatory breast cancer 4. Women with metastatic breast cancer 5. Women with contraindications to endocrine therapy, and 6. Women not willing to sign informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the clinical response rate to neoadjuvant endocrine therapy in patients with locally advanced HR+ breast cancer who are not candidates for chemotherapy. Timepoint: 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety & tolerability of NET in elderly patients. To evaluate its impact on surgical outcomes. To identify biomarker predictives of response to NET in population.Timepoint: at 3 & 6 months | — |
Countries
India
Contacts
DMIMS