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Trial Title:
Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
NCT ID:
NCT05872412
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Conditions: Keywords:
Triple negative breast cancer
Platinum
Neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
60 mg/m2 IV bolus on day 1 every three weeks for four cycles.
Arm group label:
Non-platinum based regimen
Arm group label:
Platinum-based regimen
Other name:
Adriamycin
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.
Arm group label:
Non-platinum based regimen
Arm group label:
Platinum-based regimen
Other name:
Cytoxan
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
80 mg/m2 IV over 1 hour weekly for 12 weeks
Arm group label:
Non-platinum based regimen
Arm group label:
Platinum-based regimen
Other name:
Taxol
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles
Arm group label:
Platinum-based regimen
Other name:
Paraplatin
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bangabandhu Sheikh Mujib Medical University
Address:
City:
Dhaka
Zip:
1000
Country:
Bangladesh
Contact:
Last name:
Sajib K Talukdhar, MBBS, MD
Phone:
+8801723620231
Email:
sajibkumar@bsmmu.edu.bd
Investigator:
Last name:
Mohammad J Shams, MBBS, MD
Email:
Principal Investigator
Investigator:
Last name:
Sajib K Talukdhar, MBBS, MD
Email:
Sub-Investigator
Start date:
June 1, 2023
Completion date:
April 30, 2024
Lead sponsor:
Agency:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Agency class:
Other
Source:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05872412
