Overview

MicroRNA Profiles in Triple Negative Breast Cancer

Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
0
Participant gender:
Female
Summary
Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of Blacks affected and in younger age groups. There is no targeted therapy unlike other types of breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive subtypes. Chemotherapy is therefore the main choice of systemic treatment with rapid development of resistance in most cases. At present, there is no blood test to monitor treatment response and disease relapse. This one-stage phase II study with a single arm design will determine the response rate of standard chemotherapy using Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) in TNBC patients. We will measure the blood level of microRNA molecules and circulating tumor DNA during and after treatment to test if changes can be used to indicate drug failure in these patients. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines while toxicity will be assessed using CTCAE v5). The trial will be conducted as per the International Council on Harmonisation Good Clinical Practice (ICH GCP) Guidelines E6 (R1) and other applicable guidelines
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University College Hospital, Ibadan
Collaborators:
Lagos State University
Obafemi Awolowo University Teaching Hospital
University of Chicago
University of Ibadan
University of Lagos, Nigeria
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Cyclophosphamide
Epirubicin
Paclitaxel
Criteria
Inclusion Criteria:

1. Women ages of 18 to 70 years old

2. Women who give informed consent for the study

3. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound
measurable (≥ 2cm)

4. Patients with histologically confirmed carcinoma of the female breast with triple
negative status by immuno-histochemistry (IHC)

5. Clinical stages IIA -IIIC (AJCC 2009)

6. Chemotherapy-naïve patients (for this malignancy)

7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1

8. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy
test and must commit to receive Leuteinizing Hormone Realising Hormone (LHRH) agonist
Zoladex (goserelin) for two years starting from the commencement of the study
medications

9. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as
defined by each of the following:

1. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC)
≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and
SGPT < 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or
glomerular filtration rate ≥ 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) (CKD EPI) equation (see http://mdrd.com/ for calculator) 10.
Echocardiogram (ECHO): Baseline left ventricular ejection fraction of ≥ 55%

Exclusion Criteria:

1. Pregnant or lactating women. Women of childbearing potential not using a reliable and
appropriate contraceptive method. Postmenopausal women must have been amenorrheic for
at least 12 months to be considered of non-childbearing potential.

2. Patients with distant metastasis (brain and/or visceral metastasis)

3. Serious, uncontrolled, concurrent infection(s).

4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin
cancer and treated cervical carcinoma in-situ (CCIS)

5. Participation in any investigational drug study within 4 weeks preceding the start of
study treatment

6. Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation including but not limited to chronic or active
infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive
heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or
psychiatric illness/social situations that would limit compliance with study
requirements.