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

NCT ID: NCT05872412

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-04-30

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.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platinum-based regimen

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).

Group Type: EXPERIMENTAL

Doxorubicin

Intervention Type: DRUG

60 mg/m2 IV bolus on day 1 every three weeks for four cycles.

Cyclophosphamide

Intervention Type: DRUG

600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.

Paclitaxel

Intervention Type: DRUG

80 mg/m2 IV over 1 hour weekly for 12 weeks

Carboplatin

Intervention Type: DRUG

Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles

Non-platinum based regimen

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.

Group Type: ACTIVE_COMPARATOR

Doxorubicin

Intervention Type: DRUG

60 mg/m2 IV bolus on day 1 every three weeks for four cycles.

Cyclophosphamide

Intervention Type: DRUG

600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.

Paclitaxel

Intervention Type: DRUG

80 mg/m2 IV over 1 hour weekly for 12 weeks

Interventions

Doxorubicin

60 mg/m2 IV bolus on day 1 every three weeks for four cycles.

Intervention Type: DRUG

Cyclophosphamide

600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.

Intervention Type: DRUG

Paclitaxel

80 mg/m2 IV over 1 hour weekly for 12 weeks

Intervention Type: DRUG

Carboplatin

Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles

Intervention Type: DRUG

Other Intervention Names

Adriamycin; Cytoxan; Taxol; Paraplatin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Jahan Shams

Medical Officer, Department of Clinical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad J Shams, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Countries

Bangladesh

Central Contacts

Mohammad J Shams, MBBS, MD

Role: CONTACT

jsnitol@gmail.com

+8801911177774

Sajib K Talukdhar, MBBS, MD

Role: CONTACT

sajibkumar@bsmmu.edu.bd

+8801723620231

Facility Contacts

Sajib K Talukdhar, MBBS, MD

Role: primary

sajibkumar@bsmmu.edu.bd

+8801723620231

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Other Identifiers

BSMMU/2023/6669

Identifier Type: -

Identifier Source: org_study_id