Clinical Trials /

Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer



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:

Active, not recruiting


Phase 2

Trial Eligibility



  • 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


  • Breast Cancer




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


      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

Trial Arms

Docetaxel/CarboplatinExperimentalDocetaxel 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
             estrogen receptor 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.

          -  Patients with inflammatory breast cancer are eligible if they meet both of the
             following criteria:

               1. Patient has an underlying, clinically palpable breast mass of at least 2cm, AND

               2. a corresponding lesion is visualized on mammogram or ultrasound

          -  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 upper limit of normal (ULN)

               -  Aspartate aminotransferase/alanine aminotransferase ≤ 2.5 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 human immunodeficiency virus (HIV), hepatitis C virus
             (HCV), or hepatitis B virus (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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic Complete Response
Time Frame:At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
Safety Issue:
Description:This is the complete disappearance of invasive cancer in the breast at the time of surgery


Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Mothaffar Rimawi

Trial Keywords

  • breast cancer
  • triple negative
  • TNBC
  • triple negative breast cancer

Last Updated

February 11, 2021