| CTRI Number |
CTRI/2022/06/043109 [Registered on: 09/06/2022] Trial Registered Prospectively |
| Last Modified On: |
08/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of biomolecules to know cancer response in breast cancer patients |
|
Scientific Title of Study
|
Assessment of prognostic biomarkers to predict pathological complete response in patients with non-metastatic triple-negative breast cancer using a window of opportunity design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Biswajit Dubashi |
| Designation |
Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Medical Oncology, JIPMER, Puducherry,605001, India.
Pondicherry PONDICHERRY 605001 India |
| Phone |
8056338405 |
| Fax |
|
| Email |
drbiswajitdm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Biswajit Dubashi |
| Designation |
Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Medical Oncology, JIPMER, Puducherry, India.
Pondicherry PONDICHERRY 605001 India |
| Phone |
8056338405 |
| Fax |
|
| Email |
drbiswajitdm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Biswajit Dubashi |
| Designation |
Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Medical Oncology, JIPMER, Puducherry, India.
Pondicherry PONDICHERRY 605001 India |
| Phone |
|
| Fax |
|
| Email |
drbiswajitdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR Adhoc extramural grant |
|
|
Primary Sponsor
|
| Name |
ICMR Adhoc extramural grant |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
Ph: 91-11-26588895 / 91-11-26588980, 91-11-26589794 / 91-11-26589336, 91-11-26588707
Fax: 91-11-26588662
Email:icmrhqds@sansad.nic.in |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Biswajit Dubashi |
JIPMER PONDICHERY |
Department of Medical Oncology, JIPMER, dhanvantari nagar,Pondicherry-605001 Pondicherry PONDICHERRY |
8056338405
drbiswajitdm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee- interventional studies,JIPMER Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
paclitaxel and carboplatin during the waiting period of starting definitive therapy |
Injection Paclitaxel 80 mg/m2 in 1 unit NS in Glass bottle IV infusion over 1 hour using DEHP free set and 0.2-micron filter. Injection Carboplatin AUC 2 Calculated using Calverts’ formula in 1 unit 5% dextrose IV infusion over 1 hour.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Newly diagnosed triple-negative breast cancer.
Age 18 -65 years.
ECOG PS 0/1.
Early and locally advanced breast cancer (T2/T3/T4b with or without node positive).
Planned for neo-adjuvant chemotherapy with anthracycline and taxanes.
Bone marrow function- Hb> 9g%, absolute neutrophil count > 1500/ micL, platelet > 1.5 lakhs/ mic L.
Renal function- Serum creatinine < 1.5 mg%.
Liver function- Serum bilirubin > 1.5 mg%.
Normal cardiac function.Â
|
|
| ExclusionCriteria |
| Details |
The patient is not willing to the second biopsy
Pregnant women
Breast feeding mother
Prior history of any other malignancy
Bilateral breast cancer
Patient having active local site infection
Previous allergy to chemotherapy drugs paclitaxel and carboplatin
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcome from this project is to identify pathological, imaging, and molecular biomarker which would predict pCR in TNBC patients using the window period before NACT.
We would develop a predictive score that will enable us to identify patients who will achieve pCR. This score needs to be validated in a larger population.
Once validated we will prospectively use this score in a clinical trial setting to decide on chemotherapy intensity in TNBC patients planned for NACT.
|
post neoadjuvant chemotherapy, at the end of the surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| disease free survival |
post surgery followup of patients |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: The window of opportunity design, which includes administering systemic therapy for a brief period of time between diagnosis of cancer and surgery, has sparked a lot of attention in recent years as a way to assess chemosensitivity in cancer patients prior to definitive treatment. Triple-negative breast cancer (TNBC) is an aggressive tumor subtype with inferior survival. There are limited and unreliable established biomarkers that have been identified before chemotherapy to diagnose patients likely to achieve pathological complete response (pCR). Objectives: To study the association of prognostic biomarkers with pCR in patients with non-metastatic TNBC following single-dose paclitaxel and carboplatin during the window period before neoadjuvant chemotherapy (NACT) followed by developing a composite predictive score using above parameters for the assessment of pCR in TNBC before NACT. Methods: The non-metastatic triple-negative breast cancer patients will be screened as per the inclusion-exclusion criteria. A baseline biopsy will be done for the assessment of biomarkers prior to intervention followed by a PET scan to study the change in SUV of the tumor. Patients will then receive paclitaxel and carboplatin during the window of opportunity period. The additional biopsy will be done after the intervention to assess the biomarker change followed by an additional PET scan. The post-surgery pathological response will be studied. Discussion: There is now fascinating evidence in cancer research; preoperative treatment with chemotherapy during the window period gives substantial prognostic information, which further helps in deciding treatment options. Changes in biomarkers during the short time period and their association with pathological complete response can act as surrogate markers of long-term survival outcomes. |