SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01830244

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Tailored Neoadjuvant Epirubicin and Cyclophosphamide (EC) and Nanoparticle Albumin Bound (Nab) Paclitaxel for Newly Diagnosed Breast Cancer

The aim of this project is to evaluate tailored primary systemic therapy with sequential nab paclitaxel and epirubicin and cyclophosphamide in early breast cancer. This study will be an open label phase II clinical trial. The hypothesis is that tailored neoadjuvant chemotherapy with sequential nab paclitaxel and epirubicin and cyclophosphamide is feasible and achieves high response rates. It is proposed that 60 patients will be enrolled in this study including 40 patients which are likely to have chemotherapy sensitive tumors and 20 patients who have ER positive tumors and are more likely to respond to hormonal treatment as an exploratory cohort. The target population is women with early breast cancer who are eligible for primary systemic therapy. The overall response rate in the breast will be measured. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation. Participants will have a blood test to determine a specific genotype status that may help in predicting sensitivity to chemotherapy. This genotype test result is exploratory and will not influence selection of therapy for participants. Patients will also be given the option of having he their tumour tissues used in laboratory studies involving isolating cancer initiating cells from the tumor to subsequently generate breast cancer models in the laboratory and using aptamers (chemical antibodies) to target tumours.

NCT01830244 Breast Cancer
MeSH: Breast Neoplasms
HPO: Breast carcinoma Neoplasm of the breast

1 Interventions

Name: Nab-Paclitaxel

Description: Nab-Paclitaxel- 125 mg/m2 days 1,8, 15 for 12 weeks

Type: Drug

Nab-Paclitaxel 125mg/m2


Primary Outcomes

Description: Pathological complete response defined as breast only, ypT0/ ypTis regardless of nodal status

Measure: Pathological complete response in the breast

Time: 24 weeks (time window + 4 weeks)

Secondary Outcomes

Description: Pathologic assessment

Measure: Pathologic Response rate in breast and axillary lymph nodes

Time: 24 weeks (time window + 4 weeks)

Description: Pathologic assessment

Measure: Rate of pathologic complete response and near complete response in the breast combined

Time: 24 weeks (time window + 4 weeks)

Measure: Breast conservation rate

Time: 24 weeks (time window + 4 weeks)

Measure: Progression Free Survival

Time: 5 years

Description: Safety will be measured using NCI Common Toxicity Criteria for Adverse Effects version 4.0

Measure: Safety and tolerability

Time: During treatment (24 weeks)

Other Outcomes

Measure: NQ01*2 genotype (P187S) status

Time: Baseline

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P187S

NQ01*2 genotype (P187S) status. --- P187S ---

NAD(P)H:quinone oxidoreductase 1 and NQO1*2 genotype (P187S) Nicotinamide adenine dinucleotide, (NAD+), is a coenzyme found in all cells. --- P187S ---

Cells with the homozygous NQO1*2 genotype have no measurable NQO1 activity, reflecting the very low levels of the NQO1 P187S protein, which undergoes rapid turnover via the ubiquitin proteasome pathway[43]. --- P187S ---



HPO Nodes


HPO:
Breast carcinoma
Genes 51
RAD51 RAD51C RAD51D CDKN2A KRAS MRE11 SLC22A18 STK11 MSH6 KLLN BRIP1 BRCA1 ATR BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 WRN CHEK2 APC BARD1 MLH1 NBN COL14A1 AKT1 PRKN MSH2 FGFR2 IDH1 IDH2 CTNNB1 RB1CC1 PTEN MDM2 AAGAB CDH1 RNF43 PALLD PALB2 OPCML SEC23B TP53 SDHB SDHC SDHD SMAD4 TWIST1 RAD50
Neoplasm of the breast
Genes 73
RAD51 RAD51C RAD51D CDKN2A KRAS CDKN2B CDKN2D MRE11 SLC22A18 STK11 MSH6 RASGRP1 KLLN BRIP1 MGMT BRCA1 LMNA ATR ACD BRCA2 PIK3CA PPM1D POLD1 NTHL1 POLE ESR1 POT1 MC1R MITF WRN CHEK2 APC BARD1 MLH1 PRKAR1A CASP10 NBN PRKCD COL14A1 AKT1 C11ORF95 PRKN RELA MSH2 FGFR2 IDH1 GNAS IDH2 CTNNB1 RB1CC1 PTEN MDM2 FAS FASLG AAGAB CDH1 TERT RNF43 PALLD PALB2 OPCML TERF2IP PRLR SEC23B TP53 SDHB SDHC SDHD SMAD4 BAP1 CDK4 TWIST1 RAD50