Clinical Trials /

Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity

NCT02124902

Description:

This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be developed simultaneously for the purposes of genoproteomic analysis. Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Neoadjuvant Treatment of <span class="go-doc-concept go-doc-keyword">Triple Negative</span> <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Patients With <span class="go-doc-concept go-doc-intervention">Docetaxel</span> and <span class="go-doc-concept go-doc-intervention">Carboplatin</span> to Assess Anti-tumor Activity

Title

  • Brief Title: Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity
  • Official Title: A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
  • Clinical Trial IDs

    NCT ID: NCT02124902

    ORG ID: 201404107

    Trial Conditions

    Triple Negative Breast Neoplasms

    Trial Interventions

    Drug Synonyms Arms
    Docetaxel Docefrez, Taxotere Neoadjuvant docetaxel and carboplatin
    Carboplatin Paraplatin, Paraplatin-AQ Neoadjuvant docetaxel and carboplatin

    Trial Purpose

    This is a single arm open label phase II study in women with clinical stage 2 or 3 triple
    negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete
    response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived
    xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Neoadjuvant docetaxel and carboplatin Experimental Docetaxel, Carboplatin

    Eligibility Criteria

    Inclusion Criteria:

    - Newly diagnosed clinical stage II or III breast cancer with complete surgical
    excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal.

    - Patients with PR+ tumors are allowed.

    - HER2 negative by FISH or IHC staining 0 or 1+.

    - ER less than Allred score of 3 or less than 1% positive staining cells in the
    invasive component of the tumor

    - Tumor size at least 2cm in one dimension by clinical or radiographic exam (WHO
    criteria).

    - At least 18 years of age.

    - ECOG performance status 2

    - Normal bone marrow and organ function as defined below:

    - Leukocytes 3,000/mcL

    - Absolute neutrophil count 1,500/mcl

    - Platelets 100,000/mcl

    - Serum bilirubin within (or under ) normal limits (OR total bilirubin 3.0 x
    IULN with direct bilirubin within normal range in patients with well documented
    Gilbert Syndrome)

    - AST(SGOT)/ALT(SGPT) within (or under ) normal limits

    - Creatinine within (or under) normal institutional limits OR creatinine clearance
    60 mL/min/1.73 m2 for patients with creatinine levels above institutional
    normal

    - Patients may be pre- or post-menopausal. Women of childbearing potential must agree
    to use adequate contraception (hormonal or barrier method of birth control,
    abstinence) prior to study entry and for the duration of study participation. Should
    a woman become pregnant or suspect she is pregnant while participating in this study,
    she must inform her treating physician immediately.

    - Ability to understand and willingness to sign an IRB approved written informed
    consent document (or that of legally authorized representative, if applicable).

    Exclusion Criteria:

    - Prior systemic therapy for the indexed breast cancer.

    - A history of other malignancy 5 years previous with the exception of basal cell or
    squamous cell carcinoma of the skin which were treated with local resection only or
    carcinoma in situ of the cervix.

    - Patients with bilateral or inflammatory breast cancer.

    - Currently receiving any other investigational agents.

    - A history of allergic reactions attributed to compounds of similar chemical or
    biologic composition to docetaxel or carboplatin.

    - Uncontrolled intercurrent illness including, but not limited to, ongoing or active
    infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
    arrhythmia, or psychiatric illness/social situations that would limit compliance with
    study requirements.

    - Pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test
    within 7 days of study entry if premenopausal.

    - Known HIV-positivity.

    - Sentinel lymph node biopsy

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Pathological Complete Response (pCR) rate

    Secondary Outcome Measures

    Trial Keywords