Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer

Description

There are three major subtypes of breast cancer: 1) hormone receptor-positive[express estrogen receptor alpha (ER) and/or progesterone receptor (PR)]; 2) HER2-positive 3) Triple negative (lack ER, PR and HER2). While effective targeted therapies exist for patients with ER/PR+(anti-estrogens) and HER2+ (anti-Her2 agents) disease, and some triple-negative cancers respond to DNA-damaging chemotherapy, many patients eventually exhibit disease refractory to all standard breast therapies, particularly in the metastatic setting. Many other targeted therapies have been developed for other types of solid tumors and are in the process of being evaluated for use in breast cancer, such as the epidermal growth factor receptor(EGFR) targeted agent cetuximab. Expanding catalogs of cancer mutations further dispel the notion that mutations are tumor type-specific. Identifying targetable genetic changes for which there are drugs, using non-invasive procedures, will be an increasing challenge for medical oncologists. This study represents the first step in this important process: evaluating plasma DNA as a potential route to non-invasive genomic sequencing of a solid tumor.

Study Start Date

December 2013

Estimated Completion Date

March 2016

Interventions

No interventions cited

Specialties

  • Oncology: Basic Science/Genetics,Breast

MeSH Terms

  • Breast Neoplasms
  • Plasma DNA

Study ID

Dartmouth-Hitchcock Medical Center -- D13100

Status

Unknown

Trial ID

NCT01836640

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

10

Sponsor

Dartmouth-Hitchcock Medical Center

Inclusion Criteria

  • 3.2 Radiographic evidence of new or progressive metastatic breast cancer by CT chest/abdomen/pelvis and bone scan, or by PET scan, with 3 or more distant sites of metastasis involving 2 or more organ sites appropriate for biopsy.
  • 3.3 Histologic documentation of metastatic invasive breast cancer with metastasis to a distant organ site (lung, liver, pleural/peritoneal, skin (>20 cm away from breast), and/or bone) by core needle or excisional biopsy
  • patients may consent to study prior to diagnostic procedure.
  • 3.4 Estrogen Receptor, Progesterone Receptor, and HER2 status must be available, either from archived primary tumor, or from diagnostic biopsy.
  • 3.5 Archived primary tumor must be obtainable and on-site by the date of registration, or primary tumor must be intact and biopsy-able.
  • 3.5 Patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria.
  • 3.6. The subject must agree to undergo and tolerate the research biopsy(ies) and blood draw.
  • 3.7. Prior chemotherapy, endocrine therapy, or radiotherapy with therapeutic intent is allowed.
  • 3.8. Women or men > age 18.
  • 3.9. Ability to give informed consent.
  • 3.10 Normal PT/INR
  • 3.11 Negative pregnancy test or beyond reproductive potential.
  • 3.12 Medical evaluation by medical oncology within 4 weeks.
  • 3.13 Non-smokers only are eligible, see exclusion criteria #4.

Exclusion Criteria

  • 1. Brain-only metastatic disease.
  • 2. Poor venous access (unable to tolerate 19-gauge needle).
  • 3. Unable to tolerate blood draw or research biopsy procedures.
  • 4. Current smokers, smoked at all within the last 10 years, or have a lifetime smoking history greater than equal to 5 pk years.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Mary D Chamberlin MD 800-639-6918 cancer.research.nurse@Dartmouth.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.