Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer (CADENCE)
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, triple negative, TNBC, triple negative breast cancer
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:
- Patient has an underlying, clinically palpable breast mass of at least 2cm, AND
- 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.
Sites / Locations
- TriHealth Hatton Research
- Lester & Sue Smith Breast Center at Baylor College of Medicine
- Harris Health System Smith Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Docetaxel/Carboplatin
Arm Description
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Outcomes
Primary Outcome Measures
Pathologic Complete Response
This is the complete disappearance of invasive cancer in the breast at the time of surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547987
Brief Title
Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
Acronym
CADENCE
Official Title
CADENCE: Carboplatin and Docetaxel in Neoadjuvant Treatment of ER-Negative, HER2-Negative Breast Cancer: A Co-Clinical Trial With Genoproteomic Discovery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mothaffar Rimawi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, triple negative, TNBC, triple negative breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel/Carboplatin
Arm Type
Experimental
Arm Description
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
Primary Outcome Measure Information:
Title
Pathologic Complete Response
Description
This is the complete disappearance of invasive cancer in the breast at the time of surgery
Time Frame
At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Patient has an underlying, clinically palpable breast mass of at least 2cm, AND
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mothaffar Rimawi, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
TriHealth Hatton Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Lester & Sue Smith Breast Center at Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Harris Health System Smith Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34173924
Citation
Ademuyiwa FO, Chen I, Luo J, Rimawi MF, Hagemann IS, Fisk B, Jeffers G, Skidmore ZL, Basu A, Richters M, Ma CX, Weilbaecher K, Davis J, Suresh R, Peterson LL, Bose R, Bagegni N, Rigden CE, Frith A, Rearden TP, Hernandez-Aya LF, Roshal A, Clifton K, Opyrchal M, Akintola-Ogunremi O, Lee BH, Ferrando-Martinez S, Church SE, Anurag M, Ellis MJ, Gao F, Gillanders W, Griffith OL, Griffith M. Immunogenomic profiling and pathological response results from a clinical trial of docetaxel and carboplatin in triple-negative breast cancer. Breast Cancer Res Treat. 2021 Aug;189(1):187-202. doi: 10.1007/s10549-021-06307-3. Epub 2021 Jun 26.
Results Reference
derived
Learn more about this trial
Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
We'll reach out to this number within 24 hrs