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International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment

Phase 4
Not Enrolling
Breast Cancer

Thank you

Trial Information

International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment

Patients with tumors that have spread to other parts of the body and who are about to start
systemic treatment will be eligible to take part in this study.

As is standard of care, you will have an evaluation of your disease through CT scans, bone
scans, and PET scans. Before you begin your routine treatment, participants in this study
will have 3 teaspoons of blood drawn at an M. D. Anderson clinic. This will be the only
blood draw required for this study. You will then begin receiving standard therapy for your
disease as decided by your treating physician.

You will have follow-ups with either your physician or through the research personnel (by
phone calls by the research nurse) at 3, 6, 12, 18, and 36 months. After 36 months,
follow-up will continue indefinitely at your doctor's discretion. At these follow-ups, your
medical record will be reviewed to gather information for this study.

One of the blood samples will be preserved and used for research and development purposes
specifically related to this study. This research includes also analysis of the tumor gene
profiling. This study will be done to better understand the biology of metastatic breast
cancer. Neither participants nor the doctors taking care of them will be told about the
results of the research.

This is an investigational study. CellSearch (the technology used to count circulating
tumor cells) is approved by the FDA for breast cancer prognosis. About 660 patients will
take part in this multicenter study. About 100 patients will be enrolled at M. D. Anderson.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed invasive breast cancer.
Patients must have clinical and/or radiologic evidence of stage IV disease. Tumor may
be of any hormone receptor type.

- Patients must have newly diagnosed stage IV breast cancer that is scheduled to start
a new systemic therapy.

- Patients may have measurable or non-measurable disease.

- Extent of disease will be determined by physical examination and imaging studies as
per the primary physician. The tests utilized may include: (bone scans, PET/CT scans,
CT of the abdomen, chest radiograph and/or CT of the chest for visceral metastases,
sonogram and/or MRI for soft tissue disease). Patients with skin lesions will have
photographs to evaluate their lesions.

- ECOG performance status 0-2.

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policies of the hospital. The
only acceptable consent form is the one attached at the end of this protocol.

Exclusion Criteria:

- Patients with evidence of local regional recurrence only are excluded.

- Patients who have received prior therapy for their metastatic breast disease.

- Patients with known evidence of brain metastases (unless previously treated or
stable) or carcinomatous meningitis.

- Patients with history of any prior malignancies that have not been disease-free for
at least 5 years prior to study entry.

- Patients unwilling or unable to give consent.

- Patients unwilling or unable to provided follow-up on their condition.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer.

Outcome Time Frame:

26 Months

Safety Issue:


Principal Investigator

Massimo Cristofanilli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Circulating Tumor Cells
  • Gene Profiling
  • International Stage Stratification Study
  • Blood Sample
  • ISSS
  • Breast Neoplasms
  • Neoplastic Cells, Circulating



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030