Study of Paclitaxel and Carboplatin chemotherapy in metastatic breast carcinoma

To compare the efficacy and safety of Paclitaxel vs Paclitaxel and Carboplatin combination regimens in patients with HER2/neu negative metastatic breast carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/051117

Enrollment

Registered

2023-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Paclitaxel, Carboplatin: Paclitaxel 175mg/m2, Carboplatin AUC of 5 as calculated, First day of 21-day cycle? 4 cycles Control Intervention1: Paclitaxel: Paclitaxel 175mg/m2 - First da

Eligibility

Inclusion criteria

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

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 8.Serum creatinine > 2.7 mg/dL & Creatine clearance 9. Serum total bilirubin > 1.5 times the upper limit of normal 10.ASAT (SGOT) and ALAT (SGPT) > 3x UNL

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Paclitaxel, Paclitaxel and Carboplatin combination regimen in HER2/neu negative metastatic breast cancer patients at the end of the 4th cycle of chemotherapy in both study groups.Timepoint: To compare the objective response rate of group 1 Paclitaxel with group 2 Paclitaxel and Carboplatin using the RECIST 1.1 criteria. For accessing the efficacy of the two regimens objective response rate using the targetable and non-targetable lesions of the baseline CT and after 4 cycles of chemotherapy. Measured at Baseline and 15days after 4th chemotherapy cycle	—

Measure

Time frame

To compare the efficacy of Paclitaxel, Paclitaxel and Carboplatin combination regimen in HER2/neu negative metastatic breast cancer patients at the end of the 4th cycle of chemotherapy in both study groups.Timepoint: To compare the objective response rate of group 1 Paclitaxel with group 2 Paclitaxel and Carboplatin using the RECIST 1.1 criteria. For accessing the efficacy of the two regimens objective response rate using the targetable and non-targetable lesions of the baseline CT and after 4 cycles of chemotherapy. Measured at Baseline and 15days after 4th chemotherapy cycle

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Secondary

Measure	Time frame
To compare the safety profile of Paclitaxel, Paclitaxel and Carboplatin.Timepoint: During and after each chemotherapy cycle. ;To study the association of the plasma concentration of Paclitaxel in terms of efficacy in two study groups.Timepoint: plasma concentration of paclitaxel will be measured at the end, 3hours and 24hrs after first chemotherapy cycle paclitaxel infusion.;To study the effect of single nucleotide genetic polymorphism of GSTPI rs1695 on plasma concentration & safety among two study groups.Timepoint: Percentage of SNP GSTP1 rs1695 polymorphism in two study groups at 24hours after 1st chemotherapy cycle	—

Measure

Time frame

To compare the safety profile of Paclitaxel, Paclitaxel and Carboplatin.Timepoint: During and after each chemotherapy cycle. ;To study the association of the plasma concentration of Paclitaxel in terms of efficacy in two study groups.Timepoint: plasma concentration of paclitaxel will be measured at the end, 3hours and 24hrs after first chemotherapy cycle paclitaxel infusion.;To study the effect of single nucleotide genetic polymorphism of GSTPI rs1695 on plasma concentration & safety among two study groups.Timepoint: Percentage of SNP GSTP1 rs1695 polymorphism in two study groups at 24hours after 1st chemotherapy cycle

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Countries

India

Contacts

Public ContactDr Arun S

All India Institute of Medical Sciences Jodhpur

ambwanis@aiimsjodhpur.edu.in9414912698

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026