Triple Negative Breast Cancer
Conditions
Keywords
Triple negative breast cancer, Platinum, Neoadjuvant
Brief summary
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
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.
Interventions
DRUGDoxorubicin
60 mg/m2 IV bolus on day 1 every three weeks for four cycles.
DRUGCyclophosphamide
600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.
DRUGPaclitaxel
80 mg/m2 IV over 1 hour weekly for 12 weeks
DRUGCarboplatin
Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response rate | 1 year | Pathological complete response: Post-operative pathology revealed no residual invasive cancer in the breast or lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | 1 year | Clinical response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which rely on a history, clinical exam, and imaging. |
| Treatment related acute toxicity | 1 year | The American National Cancer Institute's Common Terminology Criteria for Adverse Events will be utilized to assess toxicity. |
Countries
Bangladesh
Contacts
Primary ContactMohammad J Shams, MBBS, MD
Backup ContactSajib K Talukdhar, MBBS, MD
Outcome results
None listed