Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003095
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
1999-11-01
Brief Title:
S9719 Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S9719 Clonal Hematopoiesis as a Marker of Genetic Damage Following Adjuvant Chemotherapy for Breast Cancer Pilot Study to Evaluate Incidence Ancillary to S9623
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy for breast cancer may damage the genes of cells This may lead to the development of secondary cancers
PURPOSE Pilot study to evaluate the degree of gene damage following chemotherapy in women with stage II or stage III breast cancer involving four to nine axillary lymph nodes
PURPOSE Pilot study to evaluate the degree of gene damage following chemotherapy in women with stage II or stage III breast cancer involving four to nine axillary lymph nodes
Detailed Description:
OBJECTIVES I Estimate the incidence of early genetic damage defined by the presence of clonal hematopoiesis using the human androgen receptor assay HUMARA in pretreatment blood and bone marrow apheresis and two sequential post-treatment specimens from women with stage IIIII breast cancer enrolled in SWOG-S9623 II Detect genetic damage following dose-intensive adjuvant regimens for breast cancer by screening for the presence of defective DNA mismatch repair mechanisms and loss of heterozygosity using microsatellite instability assays III Estimate the incidence of myeloid lymphoid leukemia gene fusion transcripts in cases where either the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis IV Determine the frequency of RAS gene mutations H- K- and N-RAS following dose-intensive adjuvant regimens for breast cancer
OUTLINE Prior to beginning treatment on SWOG-9623 blood samples and bone marrow aspirates when available are collected from each patient Patients randomized to autologous peripheral stem cell transplant have specimens collected again at 3 months apheresis aliquot and blood At 3 and 12 months after completing chemotherapy blood samples are collected from all patients Samples are collected again from any patient presenting with a second malignancy in the future DNA is collected from blood or bone marrow samples Clonality at the HUMARA locus is examined Microsatellite instability is assessed at multiple chromosomal loci 7q31 5q31 17p12 8p22 11q23 and the BAT loci If the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis then specimens are examined for myeloid lymphoid leukemia fusion transcripts commonly reported in acute myeloid leukemia with 11q23 abnormalities Specimens are also examined for RAS mutations H- K- N-RAS Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL This study will accrue 100 patients for each arm of SWOG-9623 for a total of 200 patients
OUTLINE Prior to beginning treatment on SWOG-9623 blood samples and bone marrow aspirates when available are collected from each patient Patients randomized to autologous peripheral stem cell transplant have specimens collected again at 3 months apheresis aliquot and blood At 3 and 12 months after completing chemotherapy blood samples are collected from all patients Samples are collected again from any patient presenting with a second malignancy in the future DNA is collected from blood or bone marrow samples Clonality at the HUMARA locus is examined Microsatellite instability is assessed at multiple chromosomal loci 7q31 5q31 17p12 8p22 11q23 and the BAT loci If the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis then specimens are examined for myeloid lymphoid leukemia fusion transcripts commonly reported in acute myeloid leukemia with 11q23 abnormalities Specimens are also examined for RAS mutations H- K- N-RAS Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment
PROJECTED ACCRUAL This study will accrue 100 patients for each arm of SWOG-9623 for a total of 200 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9719 | OTHER | None | None |