Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

Study Overview
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Brief Summary
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In this study, individuals with triple-negative breast cancer will receive either a platinum-based or non-platinum-based preoperative chemotherapy treatment. This study will help us identify which option is the most effective and safe.

Detailed Description
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Breast cancer is a significant health concern, and triple-negative breast cancer (TNBC) is a particularly aggressive and lethal subtype. Chemotherapy is currently the only recommended systemic treatment for TNBC, with the standard regimen being a combination of anthracyclines and taxanes. Platinum agents have shown promising results in TNBC neoadjuvant chemotherapy due to their ability to damage DNA and be more effective in tumors with dysfunctional DNA repair mechanisms. However, there is still a lack of consensus on the optimal neoadjuvant chemotherapy regimen for TNBC. This study will be conducted to compare the responses and toxicities of platinum-based versus non-platinum-based neoadjuvant chemotherapy in TNBC patients receiving neoadjuvant chemotherapy in the Department of Clinical Oncology of Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh, Dhaka. After pretreatment evaluation, a total of 82 patients who fulfill the inclusion and exclusion criteria will be divided into Arm A and Arm B by simple random sampling. After the completion of the chemotherapy, all patients will undergo surgical management. A postoperative histopathology report will be collected and assessed by the investigator. During the treatment, the patients will be monitored before each cycle of chemotherapy, including physical examinations and laboratory investigations. All the relevant data will be compiled on a master chart first, and then statistical analysis of the results will be obtained by using Windows-based computer software facilities with Statistical Packages for Social Sciences. The data will be analyzed using the Chi-square test and the T' test. The results will be presented in tables, figures, and diagrams. A significant value of 'p' will be decided at a level of 0.05 in two-tailed tests.

Official Title
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Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Doxorubicin
* Drug: Cyclophosphamide
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Triple-negative breast cancer Stage II and III Exclusion Criteria: Double primaries Male breast cancer Pregnant or lactating women Patients with Eastern Cooperative Oncology Group (ECOG) performance status more than two Patients below 18 years old Initial surgery of the primary site (excluding diagnostic biopsy) Serious concomitant medical illness including clinically significant cardiovascular disease Major surgery or trauma in the previous four weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double-blinded randomized controlled trial to explore the efficacy and toxicity of platinum-based versus non-platinum-based neoadjuvant chemotherapy in triple-negative breast cancer.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platinum-based regimen<br>Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks concurrently with carboplatin (area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles). | Drug: Doxorubicin<br>* 60 mg/m2 IV bolus on day 1 every three weeks for four cycles.<br>* Other names: Adriamycin;Drug: Cyclophosphamide<br>* 600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.<br>* Other names: Cytoxan;Drug: Paclitaxel<br>* 80 mg/m2 IV over 1 hour weekly for 12 weeks<br>* Other names: Taxol;Drug: Carboplatin<br>* Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles<br>* Other names: Paraplatin;|
| Active Comparator: Non-platinum based regimen<br>Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks. | Drug: Doxorubicin<br>* 60 mg/m2 IV bolus on day 1 every three weeks for four cycles.<br>* Other names: Adriamycin;Drug: Cyclophosphamide<br>* 600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.<br>* Other names: Cytoxan;Drug: Paclitaxel<br>* 80 mg/m2 IV over 1 hour weekly for 12 weeks<br>* Other names: Taxol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response rate | Pathological complete response: Post-operative pathology revealed no residual invasive cancer in the breast or lymph nodes. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Clinical response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which rely on a history, clinical exam, and imaging. | 1 year | 
| Treatment related acute toxicity | The American National Cancer Institute's Common Terminology Criteria for Adverse Events will be utilized to assess toxicity. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triple negative breast cancer, Platinum, Neoadjuvant