PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer

NCT ID: NCT02067416

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-06-30

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.

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

taxane-based chemotherapy

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

Group Type: ACTIVE_COMPARATOR

taxane-based chemotherapy

Intervention Type: DRUG

neoadjuvant taxane based chemotherapy given as standard of care

anthacycline based chemotherapy

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

Group Type: ACTIVE_COMPARATOR

Anthracycline based chemotherapy

Intervention Type: DRUG

standard of care neoadjuvant treatment with anthracycline based chemotherapy

Interventions

Anthracycline based chemotherapy

standard of care neoadjuvant treatment with anthracycline based chemotherapy

Intervention Type: DRUG

taxane-based chemotherapy

neoadjuvant taxane based chemotherapy given as standard of care

Intervention Type: DRUG

Other Intervention Names

Adriamycin; Epirubicin; Paclitaxel; Docetaxel; Abraxane; Ixabepilone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

Jenny C. Chang, MD

OTHER

Sponsor Role: lead

Responsible Party

Jenny C. Chang, MD

Methodist Cancer Center Director (Rodriguez no longer at MCC)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Angel A Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

Related Links

https://www.houstonmethodist.org/research/clinical-trials/

Cancer-related options for clinical trial participation

Other Identifiers

0712-0127

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00007624

Identifier Type: -

Identifier Source: org_study_id