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

Primary Purpose

Triple Negative Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Doxorubicin
Cyclophosphamide
Paclitaxel
Carboplatin
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple negative breast cancer, Platinum, Neoadjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Bangabandhu Sheikh Mujib Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platinum-based regimen

Non-platinum based regimen

Arm 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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2023
Last Updated
May 24, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT05872412
Brief Title
Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Official Title
Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Triple negative breast cancer, Platinum, Neoadjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platinum-based regimen
Arm Type
Experimental
Arm 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).
Arm Title
Non-platinum based regimen
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
60 mg/m2 IV bolus on day 1 every three weeks for four cycles.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
80 mg/m2 IV over 1 hour weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles
Primary Outcome Measure Information:
Title
Pathological complete response rate
Description
Pathological complete response: Post-operative pathology revealed no residual invasive cancer in the breast or lymph nodes.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical response
Description
Clinical response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which rely on a history, clinical exam, and imaging.
Time Frame
1 year
Title
Treatment related acute toxicity
Description
The American National Cancer Institute's "Common Terminology Criteria for Adverse Events" will be utilized to assess toxicity.
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad J Shams, MBBS, MD
Phone
+8801911177774
Email
jsnitol@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sajib K Talukdhar, MBBS, MD
Phone
+8801723620231
Email
sajibkumar@bsmmu.edu.bd
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad J Shams, MBBS, MD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajib K Talukdhar, MBBS, MD
Phone
+8801723620231
Email
sajibkumar@bsmmu.edu.bd
First Name & Middle Initial & Last Name & Degree
Mohammad J Shams, MBBS, MD
First Name & Middle Initial & Last Name & Degree
Sajib K Talukdhar, MBBS, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

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