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Report for Clinical Trial NCT00127205

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.

NCT00127205 Breast Cancer
MeSH: Breast Neoplasms
HPO: Breast carcinoma Neoplasm of the breast

3 Interventions

Name: clodronate disodium

Description: Given orally

Type: Drug

Arm II

Name: ibandronate sodium

Description: Given orally

Type: Drug

Arm III

Name: zoledronic acid

Description: Given IV

Type: Drug

Arm I


Primary Outcomes

Description: Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.

Measure: Disease-free Survival

Time: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence

Secondary Outcomes

Description: Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.

Measure: Overall Survival

Time: follow up completed every 6 months for 5 years and then annually for 5 years or until death

Description: All sites of invasive disease documented within 30 days of first documentation of invasive recurrence.

Measure: Distributions of Sites of First Recurrence on the Three Arms.

Time: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence

Description: Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Measure: Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Time: Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs2297480

- Investigate whether there is an association between inherited germ-line single nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate synthase (FDPS) and the adverse event of acute phase reactions in these patients.



HPO Nodes


HPO:
Breast carcinoma
Genes 95
TP53 PPM1D CTNNB1 TP53 COL14A1 AKT1 AKT1 OPCML MDM2 BRCA1 SLC22A18 POLE BRCA2 BRCA1 SDHC NTHL1 PTEN XRCC3 MSH6 IDH1 RAD51C RAD51C CASP8 RB1CC1 PIK3CA PALLD KRAS PIK3CA CHEK2 BRIP1 MRE11 NTHL1 ATM TP53 RAD51D STK11 PRKN ESR1 PIK3CA KLLN MSH2 SDHD KRAS SEC23B HMMR PTEN POLD1 PIK3CA IDH2 BRCA1 PALB2 BRIP1 TP53 RAD51 RNF43 BARD1 BARD1 AAGAB AKT1 SMAD4 RAD50 STK11 CHEK2 RAD54L NBN CDKN2A SEC23B CDH1 WRN NQO2 PALB2 ATR PALB2 TWIST1 SDHB MSH2 BRCA2 BRCA1 RAD51 CHEK2 MLH1 BRCA1 FGFR2 TP53 PHB BRCA2 CDH1 PTEN BRCA2 CHEK2 CDKN2A APC MLH1 AKT1 APC
Neoplasm of the breast
Genes 123
PPM1D CTNNB1 PTEN MGMT AKT1 BRCA1 SLC22A18 BRCA1 SDHC NTHL1 XRCC3 APC IDH1 LMNA RAD51C CDKN2B PIK3CA PALLD CHEK2 NTHL1 ATM RAD51D ESR1 GNAS APC PIK3CA RASGRP1 SDHD PRKCD KRAS BAP1 IDH2 PALB2 FAS RAD51 RNF43 PRLR AKT1 CHEK2 CDKN2A CDH1 CDK4 RELA BRCA2 BRCA1 TERF2IP CHEK2 MLH1 BRCA1 PRKAR1A POT1 BRCA2 CDH1 TERT APC MLH1 AKT1 TP53 CASP10 TP53 COL14A1 AKT1 OPCML MDM2 POLE BRCA2 PTEN MSH6 RAD51C CASP8 RB1CC1 KRAS ACD PIK3CA BRIP1 MRE11 TP53 STK11 PRKN KLLN MSH2 SEC23B HMMR PTEN POLD1 PIK3CA BRCA1 MITF FAS BRIP1 TP53 BARD1 BARD1 AAGAB SMAD4 RAD50 STK11 RAD54L NBN C11ORF95 SEC23B WRN PTEN NQO2 PTEN PALB2 ATR PALB2 CDKN2A TWIST1 SDHB MSH2 MC1R FASLG RAD51 FGFR2 TP53 PHB PTEN BRCA2 CHEK2 CDKN2A APC