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

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ClinicalTrials.gov Identifier: NCT00003095
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : October 26, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.


Condition or disease
Breast Cancer

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 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.


Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : November 1997
Actual Primary Completion Date : February 2001
Actual Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort
bone marrow transplant
bone marrow transplant
standard chemotherapy
standard chemotherapy



Biospecimen Retention:   Samples With DNA
tissue and blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Must be enrolled in SWOG-9623 at time of registration to this study, but must not have started treatment Hormone receptor status: Not specified
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003095


  Show 83 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Marilyn L. Slovak, PhD City of Hope Comprehensive Cancer Center

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003095     History of Changes
Other Study ID Numbers: CDR0000065813
S9719 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Southwest Oncology Group:
stage II breast cancer
stage III breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases