PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02067416
Recruitment Status : Terminated (Funding agent withdrew funding)
First Posted : February 20, 2014
Last Update Posted : July 27, 2018
GE Healthcare
The Methodist Hospital System
Information provided by (Responsible Party):
Jenny C. Chang, MD, The Methodist Hospital System

February 17, 2014
February 20, 2014
July 27, 2018
July 2012
June 2014   (Final data collection date for primary outcome measure)
Compare Mammostrat score clinical response rates to chemotherapy [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT02067416 on Archive Site
pathological complete response rate compare to predictors [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer
Prospective Study To Validate The Predictive Value Of Mammostrat Score, DDR Score And TLE3 Gene When A Taxane-Based Chemo Agents Or Anthracycline-Based Chemo Agent Is Used In The Neo-Adjuvant Setting
Study of the assay, Mammostrat®. to verify its utility as a predictor or outcome tool to determine whom would benefit from chemotherapy prior to surgery. Also could be used as a clinical marker to identify patients with breast cancer who do not benefit from some preoperative chemotherapies.
The purpose of this phase II study is to find out if the test, Mammostrat® can be used as a predictor or outcome tool to determine who will best benefit from chemotherapy prior to surgery. This can be used to determine if Mammostrat assay may be used as a clinical marker to identify a subset of women with breast cancer who do not benefit from preoperative chemotherapy, either taxane/taxane-like (T) chemo agents or anthracycline-based chemotherapy and cyclophosphamide (AC).
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Anthracycline based chemotherapy
    standard of care neoadjuvant treatment with anthracycline based chemotherapy
    Other Names:
    • Adriamycin
    • Epirubicin
  • Drug: taxane-based chemotherapy
    neoadjuvant taxane based chemotherapy given as standard of care
    Other Names:
    • Paclitaxel
    • Docetaxel
    • Abraxane
    • Ixabepilone
  • Active Comparator: taxane-based chemotherapy
    physician choice: taxane-based chemotherapy to include Paclitaxel, Docetaxel, Abraxane or Ixabepilone given as standard of care
    Intervention: Drug: taxane-based chemotherapy
  • Active Comparator: anthacycline based chemotherapy
    Physician choice: anthracycline based chemotherapy including Adriamycin, Epirubicin give as standard of care
    Intervention: Drug: Anthracycline based chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with histologic confirmation of invasive breast carcinoma.
  2. Patients must have intact primary tumor.
  3. ≥18 years of age.
  4. Patients with bilateral breast cancer are eligible.
  5. Patients with second primary breast cancers are eligible.
  6. The primary breast tumor must be ≥ 2 cm by physical exam or imaging.
  7. The tumor must have been determined to be HER2-negative as follows:

    • Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to CEP17 must be < 2.2)
    • Immunohistochemistry (IHC) 0-1+; or
    • IHC 2+ and FISH-negative
  8. ECOG PS of 0, 1, or 2.
  9. Negative serum pregnancy test ≤7 days of treatment initiation and a serum or urine pregnancy test must be repeated ≤ 3 days prior to starting treatment for women of childbearing potential (WOCBP). For WOCBP, adequate contraception must be used throughout the study. For this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. Women who are already on hormonal forms of birth control may continue that treatment but must also use a barrier method.
  10. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
  11. Patient must be willing to undergo breast biopsies as required by the study protocol.
  12. Sufficient tissue must be available from the diagnostic core biopsies. If not, patients must undergo additional biopsies to perform Mammostrat.

Exclusion Criteria:

  1. Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
  2. Prior treatment with any investigational drug within the preceding 4 weeks.
  3. Evidence of New York Heart Association class III or greater cardiac disease.
  4. History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
  5. Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart Failure or major surgery) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
  6. Pregnant or nursing women.
  7. Known allergic reaction to Cremophor or any of the chemo agents on this trial.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
0712-0127 ( Other Identifier: HMRI IRB )
Not Provided
Plan to Share IPD: No
Jenny C. Chang, MD, The Methodist Hospital System
Jenny C. Chang, MD
  • GE Healthcare
  • The Methodist Hospital System
Principal Investigator: Angel A Rodriguez, MD The Methodist Hospital System
The Methodist Hospital System
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP