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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Not yet enrolling; Phase 2

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: Doxorubicin; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT05872412

BSMMU/2023/6669

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

Platinum-based regimen

Experimental group

Description:

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).

Treatment:

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Carboplatin

Drug: Paclitaxel

Non-platinum based regimen

Active Comparator group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Paclitaxel