S9719 Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003095
First received: November 1, 1999
Last updated: November 7, 2013
Last verified: November 2013

November 1, 1999
November 7, 2013
November 1997
February 2001   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003095 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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S9719 Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer
S9719: Clonal Hematopoiesis as a Marker of Genetic Damage Following Adjuvant Chemotherapy for Breast Cancer: Pilot Study to Evaluate Incidence. Ancillary to S9623

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.

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 II/III 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

tissue and blood

Non-Probability Sample

Must be enrolled in SWOG-9623 at time of registration to this study, but must not have started treatment Hormone receptor status: Not specified

Breast Cancer
Not Provided
  • bone marrow transplant
    bone marrow transplant
  • standard chemotherapy
    standard chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
February 2001
February 2001   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Must be enrolled in SWOG-9623 at time of registration to this study, but must not have started treatment Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Not specified Performance status: See Disease Characteristics Life expectancy: SWOG 0 or 1 Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See Disease Characteristics

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003095
CDR0000065813, S9719, U10CA032102
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Marilyn L. Slovak, PhD Beckman Research Institute
Southwest Oncology Group
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP