Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.
Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. Participants with HER2-positive breast cancer will receive a combination of trastuzumab with pertuzumab (PHESGO) plus chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
A chemotherapy drug.
A prescription medicine that is approved for use in combination with trastuzumab and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
A chemotherapy drug.
A medication used to treat breast cancer.
A medication used to treat breast cancer.
A hormone therapy drug.
Lagos State University Teaching Hospital
Ikeja, Lagos, Nigeria
RECRUITINGLagos University Teaching Hospital
Yaba, Lagos, Nigeria
RECRUITINGObafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
Ile-Ife, Osun State, Nigeria
RECRUITINGUniversity of Ibadan Hospital
Ibadan, Oyo State, Nigeria
RECRUITINGPathological Complete Response
Pathological complete response of giving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes at surgery.
Time frame: 10 years
Reported Adverse Events and clinical/medical records of participants
Reported adverse events among participants receiving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the incidence and severity of adverse events and serious adverse drug reactions including clinical laboratory values, vital signs, electrocardiogram and dose interruptions. Adverse events will be defined by the Common Terminology Criteria for Adverse Events (CTCAE Grade 4)
Time frame: 10 years
Percentage of participants who are suitable for breast-conserving surgery
To determine suitability of patients for breast conserving surgery after neoadjuvant treatment with docetaxel and PHESGO as assessed by the percentage of patients with breast conservative surgery following neoadjuvant therapy.
Time frame: 10 years
Event-free survival duration reported among participants
Event-free responses defined as time from first dose of study drug treatment to progression or death due to any cause, as assessed by investigators.
Time frame: 10 years
Quality of life reported among study participants
Quality of life (QoL) will be assessed by various domains of QoL over time and the changes from baseline using a QoL instrument (a global/breast module) validated by the European Organization for Research and Treatment of Cancer (EORTC). QLQ-C30 version 3.0 and Breast Cancer Module QLQ-BR23 low scores on scale of 0-4 indicates better financial wellbeing
Time frame: 10 years
Genetic and epigenetic factors associated with breast cancer in Nigeria
To assess the genetic and epigenetic factors associated with breast cancer in Nigeria asa assessed by correlative study of molecular markers and tumor subtypes/tumor biology with patient's characteristics, response or resistance to treatment and participants' outcome.
Time frame: 10 years
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