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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

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/Carboplatin Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Estimated Primary Completion Date : September 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/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




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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02547987


Contacts
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Contact: Jana Knezevic, Ph.D. 713-798-1975 knezevic@bcm.edu

Locations
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United States, Ohio
TriHealth Hatton Research Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Nancy Firsich, RN, BSN    513-865-5569    nancy_firsich@trihealth.com   
Principal Investigator: Apurva Mehta, MD         
United States, Texas
Lester & Sue Smith Breast Center at Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Jana Knezevic, PhD    713-798-1975    knezevic@bcm.edu   
Sub-Investigator: Polly A Niravath, MD         
Principal Investigator: Mothaffar F Rimawi, MD         
Sub-Investigator: Julie Nangia, MD         
Sub-Investigator: C. Kent Osborne, MD         
Sub-Investigator: Matthew J Ellis, MD         
Harris Health System Smith Clinic Recruiting
Houston, Texas, United States, 77054
Contact: Jana Knezevic, Ph.D.    713-798-1975    knezevic@bcm.edu   
Sponsors and Collaborators
Mothaffar Rimawi
Investigators
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Principal Investigator: Mothaffar Rimawi, MD Baylor College of Medicine

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Responsible Party: Mothaffar Rimawi, Associate Professor, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT02547987     History of Changes
Other Study ID Numbers: H- 36960 CADENCE
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:
breast cancer
triple negative
TNBC
triple negative breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action