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Study of Paclitaxel and Carboplatin chemotherapy in metastatic breast carcinoma

Phase 2
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Registration Number
CTRI/2023/03/051117
Lead Sponsor
ALL INDIA INSTITUTE OF MEDICAL SCIENCES Jodhpur
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Written informed consent.

2. Treatment naive metastatic HER2/neu negative breast cancer patients requiring chemotherapy.

3. Age group 18 to 75 years.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria

1. Known case of cardiac diseases (congestive heart failure, Myocardial infarction in past 1 year).

2. Pregnancy and lactating women.

3. Patients with CNS metastasis

4. Known cases of psychiatric illness

5. Patients with Sepsis

6. Clinically relevant peripheral neuropathy

7.Pancytopenia (neutropenia (Absolute neutrophil count < 1.5x109/l), thrombocytopenia (Platelet count <100x109 /l), anemia).

8.Serum creatinine > 2.7 mg/dL & Creatine clearance <30ml

9. Serum total bilirubin > 1.5 times the upper limit of normal

10.ASAT (SGOT) and ALAT (SGPT) > 3x UNL

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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