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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: taxane-based chemotherapy; Drug: Anthracycline based chemotherapy

Detailed Description

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).

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Abraxane; Docetaxel; Paclitaxel; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological complete response rate compare to predictors	The percentage of patients undergoing chemotherapy who have Mammostrat low risk scores will be calculated	2 years

Collaborators and Investigators

• Sponsor: Jenny C. Chang, MD
• Collaborators: GE Healthcare; The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Angel A Rodriguez, MD, The Methodist Hospital Research Institute

Publications and helpful links

Helpful Links

• Cancer-related options for clinical trial participation

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 17, 2014
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; neoadjuvant; DDR; mammostrat; TLE3
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Paclitaxel; Epirubicin; Taxane
• Other Study ID Numbers: Pro00007624; 0712-0127 (Other Identifier: HMRI IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No