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

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05872412
Collaborator
(none)
82
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
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.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 (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: Doxorubicin
60 mg/m2 IV bolus on day 1 every three weeks for four cycles.
Other Names:
  • Adriamycin

    • Drug: Cyclophosphamide
    600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.
    Other Names:
  • Cytoxan

    • Drug: Paclitaxel
    80 mg/m2 IV over 1 hour weekly for 12 weeks
    Other Names:
  • Taxol

    • Drug: Carboplatin
    Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles
    Other Names:
  • Paraplatin

    		•
    Active Comparator: 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.

    Drug: Doxorubicin
    60 mg/m2 IV bolus on day 1 every three weeks for four cycles.
    Other Names:
  • Adriamycin

    • Drug: Cyclophosphamide
    600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.
    Other Names:
  • Cytoxan

    • Drug: Paclitaxel
    80 mg/m2 IV over 1 hour weekly for 12 weeks
    Other Names:
  • Taxol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pathological complete response rate [1 year]

      Pathological complete response: Post-operative pathology revealed no residual invasive cancer in the breast or lymph nodes.

    Secondary Outcome Measures

    1. 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.

    2. Treatment related acute toxicity [1 year]

      The American National Cancer Institute's "Common Terminology Criteria for Adverse Events" will be utilized to assess toxicity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh 1000

    Sponsors and Collaborators

    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    Investigators

    • Principal Investigator: Mohammad J Shams, MBBS, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohammad Jahan Shams, Medical Officer, Department of Clinical Oncology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    ClinicalTrials.gov Identifier:
    NCT05872412
    Other Study ID Numbers:
    • BSMMU/2023/6669
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohammad Jahan Shams, Medical Officer, Department of Clinical Oncology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    Triple negative breast cancer
    Platinum
    Neoadjuvant
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms
    Paclitaxel
    Cyclophosphamide
    Carboplatin
    Doxorubicin

    Study Results

    No Results Posted as of May 25, 2023