PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The Methodist Hospital System
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT02067416
First received: February 17, 2014
Last updated: February 18, 2014
Last verified: February 2014

February 17, 2014
February 18, 2014
July 2012
August 2016   (final data collection date for primary outcome measure)
Compare Mammostrat score clinical response rates to chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02067416 on ClinicalTrials.gov Archive Site
pathological complete response rate compare to predictors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2018
August 2016   (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.
Both
18 Years and older
No
Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org
United States
 
NCT02067416
0712-0127
No
The Methodist Hospital System
The Methodist Hospital System
GE Healthcare
Principal Investigator: Angel A Rodriguez, MD The Methodist Hospital System
The Methodist Hospital System
February 2014

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