Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Azacytidine: Azacytidine priming with Paclitaxel + Carboplatin 4 cycles After 4 cycles response assessment will be done using CECT scan and bone scan. Patients with CR/PR/SD will recei
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant must be greater than or equal to 18 years 2. ECOG PS 0 or 1 3. Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC. 4. TNBC is defined using IHC as ER and PR negative (intensity zero percent or Alred score less than 3) Negative for HER2 with zero or one plus intensity on IHC or two plus intensity on IHC and negative by in situ hybridization per the ASCO CAP HER2 guideline (Wolff et al 2018; Allison et al 2020) 5. At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1 baseline and can be accurately measured at baseline as greater than or equal to 10 millimeters in the longest diameter (except lymph nodes, which must have short axis greater than or equal to 15 millimeters) with computed tomography or magnetic resonance imaging, and is suitable for accurate repeated measurements. 6. Eligible for receiving chemotherapy with paclitaxel and carboplatin, has had an adequate treatment washout period before Cycle 1 Day 1, defined as: Major surgery: greater than or equal to 4 weeks. Radiation therapy including palliative radiation to chest: greater than or equal to 4 weeks. Adequate organ and bone marrow function within 7 days before day of first dosing as follows: Hemoglobin greater than or equal to 9.0 grams per deciliter (red blood cell or plasma transfusion is not allowed within 1 week prior to screening assessment). Absolute neutrophil count greater than or equal to 1.5 times 10 to the power of 9 per liter (granulocyte colony stimulating factor administration is not allowed within 1 week prior to screening assessment). Platelet count greater than or equal to 100 times 10 to the power of 9 per liter (platelet transfusion is not allowed within 1 week prior to screening assessment). Total bilirubin TBL less than or equal to 3 times upper limit of normal ULN. Alanine aminotransferase ALT and aspartate aminotransferase AST less than or equal to 5 times ULN). Minimum life expectancy of 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Presence of other active malignancy 2. Known hypersensitivity to azacytidine or chemotherapy agents 3. CNS metastatic disease 4. Uncontrolled comorbidities 5. Uncontrolled or significant cardiac disease including: a) Myocardial infarction or uncontrolled or unstable angina within 6 months, Congestive heart failure (New York Heart Association Class II to IV), or b) Uncontrolled or significant cardiac arrhythmia, or c) Uncontrolled hypertension (resting systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg). 6. Patient expressing unwillingness to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study assesses Azacytidine priming with Paclitaxel and Carboplatin for mTNBC. The primary outcome of the study is overall response rates assessed by radiology.Timepoint: The assessment of primary endpoint will be performed at 3 months (end of 4 cycles). Post 4 cycles patient in CR/PR/SD will receive 2 more cycles of paclitaxel and carboplatin in both the arms without Azacytidine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include progression free survival, quality of life & biomarker assessment. Whole genome DNA methylation sequencing of circulating tumor DNA to explore potential prognostic & predictive biomarkers.Timepoint: For the secondary endpoint of progression free survival the patients will be followed up for a minimum of 6 months. Patients will be followed up every 3 months with clinical examination & Imaging after completion of 6 cycles of chemotherapy till disease progression. | — |
Countries
India
Contacts
Public ContactDr Biswajit Dubashi
Jawaharlal Institute of Post Graduate Medical Education and Research
Outcome results
None listed