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

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ClinicalTrials.gov Identifier: NCT02547987
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

Tracking Information
First Submitted Date  ICMJE September 10, 2015
First Posted Date  ICMJE September 14, 2015
Last Update Posted Date July 13, 2018
Actual Study Start Date  ICMJE November 1, 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
Pathologic Complete Response (complete disappearance of invasive cancer in the breast) [ Time Frame: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy) ]
Change History Complete list of historical versions of study NCT02547987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
Official Title  ICMJE CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Docetaxel/Carboplatin
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6
Other Names:
  • Carboplatin
  • Docetaxel
  • Taxotere
Study Arms  ICMJE Experimental: Docetaxel/Carboplatin
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Intervention: Drug: Docetaxel/Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2015)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jana Knezevic, Ph.D. 713-798-1975 knezevic@bcm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02547987
Other Study ID Numbers  ICMJE H- 36960 CADENCE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mothaffar Rimawi, Baylor Breast Care Center
Study Sponsor  ICMJE Mothaffar Rimawi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mothaffar Rimawi, MD Baylor College of Medicine
PRS Account Baylor Breast Care Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP