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Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up

20 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up



- To establish a specimen bank from peripheral blood specimens collected from women with
a full spectrum of breast disease (invasive breast cancer [IBC], ductal or lobular
carcinoma in situ [CIS], or benign breast disease [BBD]) with standardized clinical
follow up and serial specimen collection for those with IBC.

- To determine the ability of quantitative real-time reverse-transcriptase PCR (qRT-PCR)
to discriminate between patients with IBC, CIS, and BBD by comparing baseline assay
values from pre-biopsy specimens to the histologic diagnosis.

- To determine the ability of qRT-PCR to predict treatment response by comparing serial
assay values from patients with evaluable IBC to their objective response.

- To determine the ability of qRT-PCR to predict relapse by comparing the serial assay
values from all patients with IBC to their disease status.

- To determine the ability of qRT-PCR to perform as an independent prognostic factor by
comparing baseline assay values from all patients with IBC to their disease status,
stratified by known breast cancer prognostic factors.


- To perform exploratory studies identifying potential targets for novel nucleic acid and
proteomic-based early detection assays.

OUTLINE: Patients undergo baseline peripheral blood specimen collection pre-biopsy and then
periodically for up to 10 years. Specimens are analyzed for circulating tumor cells via
quantitative real-time reverse-transcriptase PCR, immunofluorescence, and bidirectional
pyrophosphorolysis-activated polymerization allele-specific amplification; and for protein
profiles via mass spectometry, liquid chromatography, enzyme digestion, and tandem mass
spectometry. Patients' tumor tissue (invasive breast cancer [IBC] only) is analyzed for p53
via IHC. Medical records are reviewed periodically.

Patients with IBC complete a quality of life assessment at baseline and every 6 months for
up to 10 years.

Inclusion Criteria


- Biopsy-confirmed diagnosis of one of the following:

- Stage I-IV infiltrating ductal or infiltrating lobular carcinoma

- Patients with early-stage disease must not have started systemic treatment;
if no systemic treatment is planned, patients must be either preoperative
or ≤ 120 days since definitive breast surgery

- Patients with locally advanced disease must be scheduled for neoadjuvant
chemotherapy prior to initiation of systemic treatment

- Ductal carcinoma in situ

- Lobular carcinoma in situ

- Benign breast disease

- Proliferative or non-proliferative

- With or without atypia


- Karnofsky performance status 50-100%

- Not pregnant

- No prior invasive cancer diagnosis within the past 5 years except for squamous cell
or basal cell carcinoma of the skin


- See Disease Characteristics

- No prior systemic therapy (chemotherapy or hormonal therapy) for patients with stage
I-III disease

Type of Study:


Study Design:


Outcome Measure:

Establishment of a specimen bank

Safety Issue:


Principal Investigator

Melanie R. Palomares, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute



Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • invasive ductal breast carcinoma
  • invasive lobular breast carcinoma
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms
  • Breast Diseases
  • Carcinoma in Situ
  • Fibrocystic Breast Disease
  • Carcinoma, Lobular



City of Hope Comprehensive Cancer CenterDuarte, California  91010
City of Hope Medical GroupPasadena, California  91105
Tower Cancer Research FoundationBeverly Hills, California  90211