COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer (CADENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02547987
Recruitment Status : Active, not recruiting
First Posted : September 14, 2015
Results First Posted : November 13, 2019
Last Update Posted : November 25, 2019
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Carboplatin Phase 2

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 ypN0).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Docetaxel/Carboplatin
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Drug: Docetaxel
Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
Other Name: Taxotere

Drug: Carboplatin
Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6

Primary Outcome Measures :
  1. Pathologic Complete Response [ Time Frame: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy) ]
    This is the complete disappearance of invasive cancer in the breast at the time of surgery

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02547987

Layout table for location information
United States, Ohio
TriHealth Hatton Research
Cincinnati, Ohio, United States, 45242
United States, Texas
Lester & Sue Smith Breast Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Harris Health System Smith Clinic
Houston, Texas, United States, 77054
Sponsors and Collaborators
Mothaffar Rimawi
Layout table for investigator information
Principal Investigator: Mothaffar Rimawi, MD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Mothaffar Rimawi, Baylor Breast Care Center:

Layout table for additonal information
Responsible Party: Mothaffar Rimawi, Associate Professor, Baylor Breast Care Center Identifier: NCT02547987    
Other Study ID Numbers: H- 36960 CADENCE
First Posted: September 14, 2015    Key Record Dates
Results First Posted: November 13, 2019
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:
breast cancer
triple negative
triple negative breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action