Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Drug: Anthracycline based chemotherapy
Drug: taxane-based chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Compare Mammostrat score clinical response rates to chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pathological complete response rate compare to predictors [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: taxane-based chemotherapy
physician choice: taxane-based chemotherapy to include Paclitaxel, Docetaxel, Abraxane or Ixabepilone given as standard of care
Drug: taxane-based chemotherapy
neoadjuvant taxane based chemotherapy given as standard of care
Other Names:
  • Paclitaxel
  • Docetaxel
  • Abraxane
  • Ixabepilone
Active Comparator: anthacycline based chemotherapy
Physician choice: anthracycline based chemotherapy including Adriamycin, Epirubicin give as standard of care
Drug: Anthracycline based chemotherapy
standard of care neoadjuvant treatment with anthracycline based chemotherapy
Other Names:
  • Adriamycin
  • Epirubicin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067416

Contacts
Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org

Locations
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Houston Methodist Cancer Center    713-441-0629    ccresearch@houstonmethodist.org   
Sub-Investigator: Jenny CN Chang, MD         
Sub-Investigator: Daniel Lehane, MD         
Sub-Investigator: Monisha Singh, MD         
Sub-Investigator: Jorge Darcourt, MD         
Sub-Investigator: Tejal Patel, MD         
Sponsors and Collaborators
The Methodist Hospital System
GE Healthcare
Investigators
Principal Investigator: Angel A Rodriguez, MD The Methodist Hospital System
  More Information

Additional Information:
No publications provided

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT02067416     History of Changes
Other Study ID Numbers: 0712-0127
Study First Received: February 17, 2014
Last Updated: February 18, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The Methodist Hospital System:
neoadjuvant
mammostrat
TLE3
DDR
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Taxane
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014