Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: All Participants | Experimental | All participants will receive a combination of:
|
|
| Phase 2 - Operable (participants who are able to have surgery) | Experimental | Participants in this group will have breast cancer that shows a complete or incomplete response (as assessed by ultrasound) to the study drug combination given in phase 1 of study. Based on how their breast cancer responds to the phase 1 study drugs, participants in this group will: - undergo surgery and will continue to receive pertuzumab (600 mg) and trastuzumab (600 mg) for 36 weeks. Participants may also receive hormone therapy (as recommended by study doctor) based on status of breast cancer. This drug will be given as an injection under the skin. Some participants in this group may also receive tamoxifen (as an oral tablet; 20 mg daily for 10 years after surgery), letrozole (as an oral tablet 2.5 mg daily for 10 years after surgery) and/or goserelin (hormone injection 10.8 mg every 1-3 months) based on their human epidermal growth factor receptor 2 (HER2) status as assessed by the treating doctor. |
|
| Phase 2 - Inoperable (participants who are not able to have surgery) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab emtansine | Drug | A chemotherapy drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Written informed consent must be obtained prior to any screening procedures
1. Granulocyte ≥ 1,500/mL 2. Platelet count ≥ 100,000/mL 3. Absolute neutrophil count ≥ l500/mL 4. Hemoglobin 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) < 2.5 x upper limit of normal for patients without liver metastases 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (see http://mdrd.com/ for calculator) 8. Echocardiogram: Baseline left ventricular ejection fraction of ≥ 55%
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
Breast cancer study.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olufunmilayo Olopade | Contact | (773) 702-1632 | folopade@medicine.bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Olufunmilayo Olopade | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lagos State University Teaching Hospital | Recruiting | Ikeja | Lagos | 100271 | Nigeria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants in this group will have breast cancer that shows a partial response (as assessed by ultrasound) to the study drugs given in phase 1 or their breast cancer stayed the same or got worse after receiving study drugs during phase 1. Based on how their breast cancer responds to the phase 1 study drug regimen, participants in this group will receive trastuzumab emtansine (intravenously) plus standard chemotherapy as recommended by their doctor.
|
|
| Pertuzumab Injection | 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. |
|
|
| Docetaxel | Drug | A chemotherapy drug. |
|
|
| Tamoxifen | Drug | A medication used to treat breast cancer. |
|
|
| Letrozole | Drug | A medication used to treat breast cancer. |
|
| Goserelin | Drug | A hormone therapy drug. |
|
|
| 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. | 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. | 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 | 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. | 10 years |
| Lagos University Teaching Hospital | Recruiting | Yaba | Lagos | 100254 | Nigeria |
|
| Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) | Recruiting | Ile-Ife | Osun State | 220005 | Nigeria |
|
| University of Ibadan Hospital | Recruiting | Ibadan | Oyo State | 200285 | Nigeria |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| C485206 | pertuzumab |
| D000077143 | Docetaxel |
| D013629 | Tamoxifen |
| D000077289 | Letrozole |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
Not provided
Not provided