Clinical Trials /

Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer

NCT02547987

Description:

The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Neoadjuvant <span class="go-doc-concept go-doc-intervention">Carboplatin</span> and <span class="go-doc-concept go-doc-intervention">Docetaxel</span> in <span class="go-doc-concept go-doc-keyword">Triple Negative</span> <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
  • Official Title: CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery
  • Clinical Trial IDs

    NCT ID: NCT02547987

    ORG ID: BaylorBCC

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Docetaxel/Carboplatin Carboplatin, Docetaxel, Taxotere Docetaxel/Carboplatin

    Trial Purpose

    The purpose of this study is to determine whether the combination of docetaxel and
    carboplatin is an effective treatment for patients with triple negative breast cancer.

    Detailed Description

    PRIMARY OBJECTIVE:

    To determine whether neoadjuvant docetaxel and carboplatin will increase the pCR rate in
    TNBC compared to historical controls. Pathologic complete response (pCR) will be defined as
    no residual invasive breast cancer in the breast and ipsilateral axillary lymph node
    (ypT0-is ypN0).

    Trial Arms

    Name Type Description Interventions
    Docetaxel/Carboplatin Experimental Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles Docetaxel/Carboplatin

    Eligibility Criteria

    Inclusion Criteria:

    - All patients must be 18 years of age or older.

    - All patients must be diagnosed with invasive breast cancer.

    - Breast cancer must be ER-negative, and HER-2 negative according to CAP/ASCO
    biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of
    less than 5.

    - Primary breast tumor size at least 2 cm in one dimension by clinical or radiographic
    exam. Patients who have multicentric breast cancer are eligible if each lesion is
    ER-negative and HER2-negative. In that case, one lesion needs to be identified as the
    index lesion to be followed for clinical response. The index lesion must also be the
    lesion from which core biopsies are obtained.

    - Normal bone marrow and organ function as defined below:

    - Leukocytes > 3,000/mcL

    - Absolute neutrophil count > 1,200/mcl

    - Platelets > 100,000/mcl

    - Serum bilirubin institutional 1.5 times ULN

    - AST(SGOT)/ALT(SGPT) 1.5 times ULN

    - Creatinine 1.5 ULN

    - Women of childbearing potential (defined as women under the age of 55 with intact
    ovaries and uterus) must agree to use adequate contraception prior to study entry and
    for the duration of study participation. They must also have a negative urine
    pregnancy test within 7 days of starting treatment.

    - Ability to understand and willingness to sign an IRB approved written informed
    consent document and follow study procedures including willingness to undergo study
    biopsies.

    Exclusion Criteria:

    - Any prior systemic therapy for breast cancer within 5 years.

    - 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 known bilateral invasive breast cancer. Patients with contralateral in
    situ breast carcinoma are eligible.

    - Inflammatory breast cancer.

    - Patients with confirmed stage IV disease.

    - Currently receiving any other investigational agents.

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

    - Known to be seropositive for HIV, HCV, or HBV.

    - 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.

    - If the patient is otherwise not deemed a good study candidate by sole discretion of
    the principal investigator.

    - Patient is pregnant or breastfeeding.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Pathologic Complete Response (complete disappearance of invasive cancer in the breast)

    Secondary Outcome Measures

    Trial Keywords

    breast cancer

    triple negative

    TNBC

    triple negative breast cancer