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Carboplatin and Docetaxel in Treating Participants with Estrogen Receptor Negative and HER2 Negative Breast Cancer

Trial Status: Active

This phase II trial studies how well docetaxel and carboplatin work in treating participants with estrogen receptor negative and HER2 negative breast cancer. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Inclusion Criteria

  • All patients must be diagnosed with invasive breast cancer
  • Breast cancer must be estrogen receptor (ER)-negative, and HER-2 negative according to College of American Pathologists (CAP)/American Society of Clinical Oncology (ASCO) biomarkers testing guidelines; tumors may be progesterone receptor (PgR) positive with an Allred score of less than 5
  • Primary breast tumor size at least 2 centimeter (cm) in one dimension by clinical or radiographic exam; patients who have multicentric breast cancer are eligible if each lesion is ER-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 2 cm, AND * A corresponding lesion is visualized on mammogram or ultrasound
  • 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) (OR for patients with documented Gilbert syndrome, total bilirubin ≤ 3.0 times ULN with direct bilirubin ≤ ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 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 Institutional Review Board (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
  • 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)
  • Any prior treatment with taxotere or carboplatin
  • 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

Ohio

Cincinnati
TriHealth Cancer Institute-Kenwood
Status: ACTIVE
Contact: Mothaffar Fahed Rimawi
Phone: 713-798-1999

Texas

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: ACTIVE
Contact: Mothaffar Fahed Rimawi
Phone: 713-798-1999
Ben Taub General Hospital
Status: ACTIVE
Contact: Mothaffar Fahed Rimawi
Phone: 713-798-1999

PRIMARY OBJECTIVES:

I. To determine whether neoadjuvant docetaxel and carboplatin will increase the pathological complete response (pCR) rate in triple negative breast cancer (TNBC) compared to historical controls.

SECONDARY OBJECTIVES:

I. To determine the xenografting rate from TNBC patients being treated with neoadjuvant chemotherapy.

II. To compare chemotherapy responses in patient-derived xenograft (PDX) and TNBC patients being treated with neoadjuvant chemotherapy.

III. To investigate genomic and proteomic molecular changes in PDX and corresponding host patients with the intent to identify predictors of drug response and resistance.

OUTLINE:

Participants receive docetaxel intravenously (IV) and carboplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks, participants undergo surgery.

After completion of study treatment, participants are followed up at 2 months and then annually for up to 5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center

Principal Investigator
Mothaffar Fahed Rimawi

  • Primary ID CADENCE
  • Secondary IDs NCI-2018-00731
  • Clinicaltrials.gov ID NCT02547987