MicroRNA Profiles in Triple Negative Breast Cancer

ConditionTriple Negative Breast Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-70

SponsorUniversity College Hospital, Ibadan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Epirubicin
Drug
Epirubicin is an antitumor antibiotics with good activity on breast cancer. It has less cardiotoxic effect than doxorubicin
Cyclophosphamide
Drug
Cyclophosphamide is a cytoxic drug indicated for the treatment of many malignancies including breast cancer
Paclitaxel
Drug
Paclitaxel is a taxane chemotherapy agent indicated for the treatment of many cancers including breast cancer. It can be used alone or in combination with other drugs
Carboplatin
Drug
Carboplatin is a platinum compound indicated for the treatment of many types of malignancies including breast cancer

Treatment groups

42 Participants

are divided into 1 treatment group

Group A: Epirubicin-Cyclophosphamide plus Paclitaxel- CarboplatinExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Number of participants achieving pathological complete response (pCR) at surgery following neoadjuvant treatment with epirubicin + cyclophosphamide every three weeks for four cycles followed by paclitaxel + carboplatin every three weeks for four cycles

Percentage of participants achieving pathological complete response (pCR) at surgery

Time frame

4 - 6 months from commencement of chemotherapy. (Surgery will be performed within 4-6 weeks after completion of chemotherapy

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

Percentage of participants experiencing grades 3 and 4 hematological, gastro-intestinal, neurological and cardiovascular toxicities.

Time frame

From the date of commencement of chemotherapy till date of first documentation of adverse event up to 60 months or withdrawal or death from any cause or which ever occurs first.

Secondary outcomes

Number of Participants without disease for 2 , 5 and 10 years respectively

Invasive Disease Free Survival (iDFS )

Time frame

From date of first dose of study drug treatment up to a maximum of 120 months years.

Change in quality of life (QoL) score of patients from baseline using the EORTC quality of life questionnaire during chemotherapy and at study completion

The various domains of QoL over time and the changes from baseline using the validated European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).

Time frame

From date of commencement of study medications up to 60 months

Other outcomes

The serum levels of circulating microRNAs during chemotherapy in TNBC. To explore mechanisms of resistance to chemotherapy in Nigerian women with TNBC

The fold change in serum levels of miRNA during chemotherapy will be determine in TNBC patients before and during each course of chemotherapy.

Time frame

From date of commencement of chemotherapy up to 24 weeks

Sponsors and contacts

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University College Hospital, Ibadan

Lead sponsor

Lagos State University

Collaborator

Obafemi Awolowo University Teaching Hospital

Collaborator

University of Chicago

Collaborator

University of Lagos, Nigeria

Collaborator

University of Ibadan

Collaborator

Source ClinicalTrials.gov

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