None listed
Conditions
Interventions
Intervention1: Treatment Arm A: Standard Treatment (Doxorubicin + Cyclophosphamide IV Injection)
: - Doxorubicin injection at 60 mg/m , administered every 3 weeks as a 1-hour intravenous infusion.
- C
Sponsors
D.K.Srinivasaprabhu
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients aged between 18 and 65 years, with a pathologically confirmed diagnosis of invasive breast carcinoma 2. Patients with documented HER-2/Neu status, either negative or positive 3. Patients presenting with bi-dimensionally measurable and evaluable disease lesions 4. Patients showing no evidence of disease beyond the breast or chest wall, except for involvement of ipsilateral axillary lymph nodes 5. Patients with a life expectancy of at least 6 months at the time of screening 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Patients with a chest CT scan at screening that shows no evidence of metastatic disease 8. Patients who are willing and able to provide written informed consent prior to study participation 9. Patients of childbearing potential who agree to use effective contraceptive methods throughout the study duration and for at least 3 months following its completion 10. Patients must have baseline laboratory values within the following acceptable ranges at screening: white blood cell count less than or equal to 3000/mm absolute neutrophil count less than or equal to 2000/mm hemoglobin concentration less than or equal to 8 g/dL, platelet count less than or equal to 100,000/mm ; serum creatinine greater than or equal to 1.5 times the upper normal limit (UNL), alkaline phosphatase greater than or equal to 1.5 UNL; total serum bilirubin greater than or equal to 1.5 the institutional UNL; serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 1.5 UNL; and serum calcium within the institution-defined normal range 11. Patients with a negative pregnancy test result at the time of screening
Exclusion criteria
Exclusion criteria: 1. Patients with prior systemic treatment for breast cancer, including hormonal therapy, chemotherapy, or any other form of anticancer therapy 2. Patients who have received prior radiation therapy 3. Patients who have received, are currently receiving, or are scheduled to receive post-operative radiotherapy 4. Patients with a history of any malignancy other than breast cancer 5. Patients currently taking alternative therapies for cancer must discontinue such therapies prior to enrolment with appropriate washout period, alternative therapies are not permitted during either the treatment or follow-up phases of the study 6. Patients with peripheral neuropathy of Grade 2 or higher 7. Patients with electrocardiogram (ECG) findings that show significant abnormalities, as determined by the investigator 8. Patients who are medically unstable, including but not limited to those with active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, or superior vena cava syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Radiographic evaluation will be conducted as per the Response Evaluation Criteria in Solid Tumors (RECIST), which includes the following assessments, a. Chest computed tomography (CT) imaging for evaluation of clinical lesions. b. CT imaging for objective tumor response evaluation. c. Tumor markers (HER2, CA15-3, CA27-29) and histological assessment. 2. Improvement in Quality of life (SF-36) comparing baseline with end of study.Timepoint: The radiographic evaluations will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Time frame: Visits 4, 6, and 8 -CT imaging Time frame: visits 4,6, and 8 -Tumor markers (HER2, CA15-3, CA27-29) Time Frame: Screening Visit (Visit 1), Week 6 (Visit 4), Week 12 (Visit 6), Week 18 (Visit 8). and histological assessment at Screening Visit 2. Quality of life will be evaluated at two key time points Time frame: baseline and end of study (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. NCI (National Cancer Institute) toxicity criteria at every course-adverse events were summarized by NCI CTC (Common Toxicity Criteria). 2. TEAEs will be graded and tabulated by severity and relationship to the study medications.Timepoint: (Time frame from baseline to EOS). | — |
Countries
India
Contacts
Public ContactD.K.Srinivasaprabhu
Sanjeev Biomedical Research Centre
Outcome results
None listed