PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer

NCT02067416 | Withdrawn Phase 2

• 2 other identifiers: Pro000076240712-0127
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

neoadjuvant; mammostrat; TLE3; DDR; breast cancer

Outcome Measures

Primary Outcomes (1)

• Compare Mammostrat score clinical response rates to chemotherapy

  The percentage of patients undergoing chemotherapy who have Mammostrat low risk scores will be calculated

  2 years

Secondary Outcomes (1)

• pathological complete response rate compare to predictors

  2 years

Study Arms (2)

taxane-based chemotherapy

ACTIVE COMPARATOR

physician choice: taxane-based chemotherapy to include Paclitaxel, Docetaxel, Abraxane or Ixabepilone given as standard of care

Drug: taxane-based chemotherapy

anthacycline based chemotherapy

ACTIVE COMPARATOR

Physician choice: anthracycline based chemotherapy including Adriamycin, Epirubicin give as standard of care

Drug: Anthracycline based chemotherapy

Interventions

Anthracycline based chemotherapy DRUG

standard of care neoadjuvant treatment with anthracycline based chemotherapy

Also known as: Adriamycin, Epirubicin

anthacycline based chemotherapy

taxane-based chemotherapy DRUG

neoadjuvant taxane based chemotherapy given as standard of care

Also known as: Paclitaxel, Docetaxel, Abraxane, Ixabepilone

taxane-based chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologic confirmation of invasive breast carcinoma.
• Patients must have intact primary tumor.
• ≥18 years of age.
• Patients with bilateral breast cancer are eligible.
• Patients with second primary breast cancers are eligible.
• The primary breast tumor must be ≥ 2 cm by physical exam or imaging.
• 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
• ECOG PS of 0, 1, or 2.
• 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.
• 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.
• Patient must be willing to undergo breast biopsies as required by the study protocol.
• Sufficient tissue must be available from the diagnostic core biopsies. If not, patients must undergo additional biopsies to perform Mammostrat.

You may not qualify if:

• 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.
• Prior treatment with any investigational drug within the preceding 4 weeks.
• Evidence of New York Heart Association class III or greater cardiac disease.
• History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
• 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.
• Pregnant or nursing women.
• Known allergic reaction to Cremophor or any of the chemo agents on this trial.

Sponsors & Collaborators

• Jenny C. Chang, MD: lead
• GE Healthcare: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Links

• Cancer-related options for clinical trial participation

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Epirubicin; Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Angel A Rodriguez, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Methodist Cancer Center Director (Rodriguez no longer at MCC)

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 20, 2014
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)