Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer

Running, not enrolling · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT02547987
Run by: Mothaffar Rimawi
People needed: 25
Starts: 2015-11-01
Expected to finish: 2025-09-01
Last updated by the study team: 2025-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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