Status:
UNKNOWN
MicroRNA Profiles in Triple Negative Breast Cancer
Lead Sponsor:
University College Hospital, Ibadan
Collaborating Sponsors:
Lagos State University
Obafemi Awolowo University Teaching Hospital
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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...
Detailed Description
Triple negative subtype of breast cancer (TNBC), accounts for about 55% of all breast cancer among indigenous blacks, such as Nigerians, and younger women are more susceptible Patients with TNBC gener...
Eligibility Criteria
Inclusion
- Women ages of 18 to 70 years old
- Women who give informed consent for the study
- Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with triple negative status by immuno-histochemistry (IHC)
- Clinical stages IIA -IIIC (AJCC 2009)
- Chemotherapy-naïve patients (for this malignancy)
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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
- 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
- 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.
- Patients with distant metastasis (brain and/or visceral metastasis)
- Serious, uncontrolled, concurrent infection(s).
- Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment
- 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.
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04771871
Start Date
November 29 2021
End Date
August 1 2023
Last Update
February 18 2022
Active Locations (4)
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1
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Oshun, Nigeria
2
University College Hospital
Ibadan, Oyo State, Nigeria, 200221
3
Lagos State University Teaching Hospital
Lagos, Nigeria
4
Lagos University Teaching Hospital
Lagos, Nigeria