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Phase 2
18 Years
N/A
Open (Enrolling)
Female
Triple Negative Breast Cancer

Thank you

Trial Information


Inclusion Criteria:



- invasive breast cancer

- stage I-IIIA disease

- ER, PR, Her2/neu-negative status

- no prior treatment for breast cancer

- age 18 years of greater

- normal renal, liver function

- normal hematologic status

- ECOG Performance status 0, 1

- Evaluation by a surgeon to determine breast conservation eligibility

- Women of childbearing potential must have a documented negative pregnancy test within
2 months of study trial entry and agree to birth control during the duration of the
trial therapy

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Metastatic breast cancer

- Inoperable breast cancer, including Stage IIIB and IIIC

- Tumor size less than 1 centimeter

- Prior surgery, systemic therapy, or radiotherapy for the current cancer

- Hormone receptor-positive breast cancer

- Her2/neu-positive breast cancer

- Any concurrent condition which in the investigator's opinion makes it inappropriate
for the patient to participate in the trial or which would jeopardize compliance with
the protocol

- Pregnant or nursing women

- Receipt of any investigational agents within 30 days prior to commencing study
treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic complete response

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TCD11487

NCT ID:

NCT00813956

Start Date:

December 2008

Completion Date:

November 2012

Related Keywords:

  • Triple Negative Breast Cancer
  • triple negative breast cancer
  • Breast Neoplasms

Name

Location

Stanford Comprehensive Cancer CenterStanford, California  94305
PrECOGPhiladelphia, Pennsylvania  19103