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.
Women ages of 18 to 70 years old
Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (≥ 2cm)
Measurable breast tumour using ultrasonography (≥ 2cm)
Patients with histologically confirmed carcinoma of the female breast with positive HER2 status
Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue the use of acceptable form of contraception for 7 months from the date of last drug administration (Herceptin).
Patients with distant metastasis
Serious, uncontrolled, concurrent infection(s).
Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.
Crossover
Trastuzumab emtansine
DrugA chemotherapy drug.
Pertuzumab Injection
DrugA 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.
Docetaxel
DrugA chemotherapy drug.
Tamoxifen
DrugA medication used to treat breast cancer.
Letrozole
DrugA medication used to treat breast cancer.
Goserelin
DrugA hormone therapy drug.
Pathological 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.
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)
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.
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.
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
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