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A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00355316
First received: July 19, 2006
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.


Condition Intervention
Breast Neoplasms
Other: Blood draw

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Peripheral Blood Molecular Staging of Breast Cancer: A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The prevalence of breast cancer cells in the peripheral blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Specifically, it is predicted that 60% of subjects with Stage IV breast cancer will have evidence of breast cancer cells in the peripheral blood by multi-marker real-time RT-PCR analysis, and that these subjects will experience a significantly decreased progression-free and overall survival.


Secondary Outcome Measures:
  • Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy. [ Time Frame: Until patient death ] [ Designated as safety issue: No ]
    Specifically, we will determine if molecular detection of circulating breast cancer cells after the initiation of systemic therapy is associated with a significantly decreased progression-free and overall survival.

  • Quantify baseline molecular marker expression levels in the peripheral blood of healthy volunteers [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
    Determine if baseline molecular marker expression levels are dependent on patient age, race, and/or the presence of benign breast disease.

  • Compare molecular analyses to the results of the CellSeach assay [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: November 2005
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage IV Breast Cancer
Blood draws at baseline before systemic therapy. Blood draw then every 6 weeks for approximately 12 weeks.
Other: Blood draw
Healthy Volunteers
Baseline blood draw.
Other: Blood draw

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria - Stage IV breast cancer patients

  1. Patient age must be > 21 years.
  2. Patient must have a tissue diagnosis of invasive breast cancer.
  3. Patient must have documented evidence of metastatic disease.
  4. Patient must have measurable lesions.
  5. Patients must be initiating systemic therapy. Patients receiving hormonal therapy, and/or chemotherapy alone or in combination with other therapies are eligible.
  6. Patient must have an ECOG performance status of 0, 1, or 2.
  7. Patient must be available for follow-up.
  8. Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
  9. The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).

Inclusion Criteria - Healthy volunteers

A volunteer will be eligible for inclusion in this study only if ALL of the following criteria apply:

  1. Volunteer age must be > 21 years.
  2. Volunteer or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
  3. Patients with benign breast disease are eligible for enrollment.
  4. The volunteer with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided both of the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patient has been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).

Exclusion Criteria:

Exclusion Criteria - Stage IV breast cancer patients

A patient will be ineligible for inclusion in this study if ANY of the following criteria apply:

  1. No documented metastatic disease.
  2. No measurable lesions.
  3. Bone only and/or brain metastasis.
  4. Patient is not initiating a new regimen of systemic therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355316

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: William E. Gillanders, M.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
Pantel, K., R.J. Cote, and O. Fodstad. 1999. Detection and lcinical importance of micrometastic disease. Journal National Cancer Institute 91:1113-1124.
Emmert-Buck, M.R., R.F. Bonner, P.D. Smith, R.F. Chuaqui, Z. Zhuang, S.R. Goldstein, R.A. Weiss, and L.A. Liotta. 1996. Laser capture microdissection. Science 274:998-1001.
Perou, C.M., T. Sorlie, M.B. Eisen, M. van de Rijn, S.S. Jeffrey, C.A. Rees, J.R. Pollack, D.T. Ross, H. Johnsen, L.A. Akslen, O. Fluge, A. Pergamenschikov, C. Williams, S.X. Zhu, P.E. Lonning, A.L. Borresen-Dale, P.O. Brown, and D. Botstein. 2000. Molecular portraits of human breast tumours. Nature 406:747-752.
Hedenfalk, I., D. Duggan, Y. Chen, M. Radmacher, M. Bittner, R. Simon, P. Meltzer, B. Gusterson, M. Esteller, O.P. Kallioniemi, B. Wilfond, A. Borg, and J. Trent. 2001. Gene-expression profiles in hereditary breast cancer. N Engl J Med 344:539-548.
Staunton, J.E., D.K. Slonim, H.A. Coller, P. Tamayo, M.J. Angelo, J. Park, U. Scherf, J.K. Lee, W.O. Reinhold, J.N. Weinstein, J.P. Mesirov, E.S. Lander, and T.R. Golub. 2001. Chemosensitivity prediction by transcriptional profiling. Proc Natl Acad Sci U S A 98:10787-10792.
Banks, R.E., M.J. Dunn, D.F. Hochstrasser, J.C. Sanchez, W. Blackstock, D.J. Pappin, and P.J. Selby. 2000. Proteomics: new perspectives, new biomedical opportunities. Lancet 356:1749-1756.
Mikhitarian, K., W.E. Gillanders, J.S. Almeida, R.H. Martin, J.C. Varela, J.S. Metcalf, D.J. Cole, and M. Mitas. 2005. Relative levels of gene expression are correlated with the ability to detect micrometastatic breast cancer: statistical analysis of data from a multi-institutional prospective cohort study and development of an innovative microarray strategy. Clin Cancer Res In Press.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00355316     History of Changes
Other Study ID Numbers: 05-0435 / 201109033
Study First Received: July 19, 2006
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Peripheral
Blood

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

ClinicalTrials.gov processed this record on November 23, 2014