Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer

Breast Cancer Clinical Trial

— CADENCE  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02547987
• Other study ID #: H- 36960 CADENCE
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 1, 2015
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Baylor Breast Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
• Carboplatin
Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6

Locations

Country	Name	City	State
United States	TriHealth Hatton Research	Cincinnati	Ohio
United States	Harris Health System Smith Clinic	Houston	Texas
United States	Lester & Sue Smith Breast Center at Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mothaffar Rimawi

Country where clinical trial is conducted

United States, 

Outcome

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