Evaluation of biomolecules to know cancer response in breast cancer patients
- Conditions
- Malignant neoplasm of breast of unspecified site,
- Registration Number
- CTRI/2022/06/043109
- Lead Sponsor
- ICMR Adhoc extramural grant
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 80
- 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. post neoadjuvant chemotherapy, at the end of the surgery 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 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. post neoadjuvant chemotherapy, at the end of the surgery
- Secondary Outcome Measures
Name Time Method disease free survival post surgery followup of patients
Trial Locations
- Locations (1)
JIPMER PONDICHERY
🇮🇳Pondicherry, PONDICHERRY, India
JIPMER PONDICHERY🇮🇳Pondicherry, PONDICHERRY, IndiaDr Biswajit DubashiPrincipal investigator8056338405drbiswajitdm@gmail.com