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Tumor Specific Plasma DNA in Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Tumor Specific Plasma DNA in Breast Cancer

Inclusion Criteria:

- Histologic documentation of invasive breast cancer by core needle or incisional

- The invasive cancer must be hormone receptor poor, defined as both estrogen receptor
and progesterone receptor staining present in fewer than 10% of invasive cancer cells
by IHC.

- The invasive cancer must be Her-2 negative, defined as IHC 0-1+ or with a FISH ratio
of < 1.8 if IHC is 2+.

- Clinical Stage II-III invasive breast cancer with the intent to perform surgical
resection after neoadjuvant chemotherapy. Patients with multicentric or bilateral
disease are eligible if the target lesions meet the other eligibility criteria.

- The subject must agree to undergo the pre-treatment research biopsy.

- No prior chemotherapy, endocrine therapy, or radiotherapy with therapeutic intent is

- No baseline neuropathy > Grade 2.

- Women or men > age 18.

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

- Pregnant or nursing women are not eligible. All women of reproductive potential must
have a negative pregnancy test at baseline and agree to use an effective, nonhormonal
method of contraception during the period of treatment on this trial.

- The pre-treatment echocardiogram or multiple gated acquisition scan (MUGA) must have
an left ventricular ejection fraction (LVEF) above 50%.

- Required pre-treatment laboratory values include:

- Granulocytes > 1,000/mcL (microliters)

- Platelets > 100,000/mcL

- Total bilirubin < 1.5 x upper limit of normal

- Calculated creatinine clearance > 30 mL/minute

- Serum AST (Aspartate Aminotransferase) < 2.5 x upper limit of normal

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Circulating tumor levels correlation to response

Outcome Description:

To determine whether acute increases in the levels of circulating tumor DNA correlate with response to neoadjuvant chemotherapy in women with early-stage breast cancer.

Outcome Time Frame:

6 months

Safety Issue:



United States: Data and Safety Monitoring Board

Study ID:




Start Date:

October 2012

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756