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This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant taxotere and trastuzumab | Experimental | Investigators will give patients docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Administered to all patients for a minimum of 4 cycles for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Pathologic Response (pCR) | Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders. | 4-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions. | 4-6 months |
| Progression-free Survival (PFS) |
Not provided
Inclusion Criteria:
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 CKD EPI equation (see http://mdrd.com/ for calculator)
9. ECHO: Baseline left ventricular ejection fraction of ≥ 55%
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olufunmilayo I Olopade, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Hospital, Ibadan, Nigeria | Ibadan | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32628583 | Derived | Ntekim AI, Ibraheem A, Sofoluwe AA, Kotila O, Babalola C, Karrison T, Olopade CO. ARETTA: Assessing Response to Neoadjuvant Taxotere and Subcutaneous Trastuzumab in Nigerian Women With HER2-Positive Breast Cancer: A Study Protocol. JCO Glob Oncol. 2020 Jul;6:983-990. doi: 10.1200/GO.20.00043. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Taxotere and Trastuzumab | Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2019 |
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| Herceptin | Drug | Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. |
|
|
| FEC | Drug | Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). |
|
| Tamoxifen | Drug | Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. |
|
| Letrozole | Drug | Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. |
|
| LHRH agonist | Drug | Administered to all premenopausal patients. |
|
Time from enrollment to disease recurrence or death from any cause. |
| From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years |
| Duration of Response (DOR) | Time from pathological complete response to disease recurrence or death | Up to 10 years |
| Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to End of Neoadjuvant Therapy. | Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy |
| Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to End of Neoadjuvant Therapy. | Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy |
| Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to 6 Months Post-therapy. | Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | From start date of therapy to 6 months post-therapy |
| Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to 6 Months Post-therapy. | Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | From start date of therapy to 6 months post-therapy |
| Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC | The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module). | From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years |
| Blood Concentrations of Herceptin SC Given in Combination With Docetaxel | Blood concentrations of Herceptin SC at multiple time points using the peak exposure | 21 days |
| Drug Plasma Concentration of Herceptin SC Given in Combination With FEC | Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH | 21 days |
| The Cardiac Toxicity Associated With TscH With FEC +scH in Breast Cancer Patients | The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) or a decrease in LVEF of at least 10 EF points from baseline and to below 50%. | Through study completion an average of two years |
| The Cardiac Toxicity Associated With TscH Without FEC +scH in Breast Cancer Patients | The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%. | Through study completion an average of two years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Taxotere and Trastuzumab | Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Complete Pathologic Response (pCR) | Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders. | Posted | Count of Participants | Participants | 4-6 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions. | Posted | Count of Participants | Participants | 4-6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Time from enrollment to disease recurrence or death from any cause. | Not Posted | Sep 2026 | From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Time from pathological complete response to disease recurrence or death | Not Posted | Sep 2026 | Up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to End of Neoadjuvant Therapy. | Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | Posted | Mean | Standard Error | units on a scale | From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to End of Neoadjuvant Therapy. | Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | Posted | Mean | Standard Error | units on a scale | From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to 6 Months Post-therapy. | Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | Patient completing 6 months of follow-up. | Posted | Mean | Standard Error | units on a scale | From start date of therapy to 6 months post-therapy |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to 6 Months Post-therapy. | Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening. | Patient completing 6 months of follow-up | Posted | Mean | Standard Error | units on a scale | From start date of therapy to 6 months post-therapy |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC | The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module). | Not Posted | Sep 2026 | From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Blood Concentrations of Herceptin SC Given in Combination With Docetaxel | Blood concentrations of Herceptin SC at multiple time points using the peak exposure | Not Posted | Dec 2025 | 21 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Drug Plasma Concentration of Herceptin SC Given in Combination With FEC | Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH | Not Posted | Dec 2025 | 21 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Cardiac Toxicity Associated With TscH With FEC +scH in Breast Cancer Patients | The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) or a decrease in LVEF of at least 10 EF points from baseline and to below 50%. | Posted | Count of Participants | Participants | Through study completion an average of two years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Cardiac Toxicity Associated With TscH Without FEC +scH in Breast Cancer Patients | The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%. | Posted | Count of Participants | Participants | Through study completion an average of two years |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant Taxotere and Trastuzumab | Docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Docetaxel: Administered to all patients for a minimum of 4 cycles for 12 weeks. Herceptin: Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. FEC: Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). Tamoxifen: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. Letrozole: Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. LHRH agonist: Administered to all premenopausal patients. | 0 | 47 | 7 | 47 | 47 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Laboratory abnormality | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theodore Karrison (Research Professor) | University of Chicago | (773) 702-2453 | tkarrison@health.bsd.uchicago.edu |
| Aug 15, 2024 |
| Prot_SAP_000.pdf |
Not provided
| 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 |
|---|---|
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| D013629 | Tamoxifen |
| D000077289 | Letrozole |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| 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 |
| 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
| African/Other |
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