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This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.
This is a phase I/II study which will evaluate the complication rates, local control, cosmetic results, and quality of life of single fraction high gradient partial breast irradiation (HG-PBI) when used as the sole method of radiation therapy for patients with pathologic stage 0 (=< 2 cm) or I carcinoma of the breast treated with partial mastectomy with histologically assessed negative surgical margins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (HG-PBI) | Experimental | Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| accelerated partial breast irradiation | Radiation | Undergo HG-PBI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Are Free of Serious Treatment Related Toxicity | Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up. | Up to 5 years |
| Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast | Percentage of patients without ipsilateral breast tumor recurrences (IBTR). | At 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes | Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups. | At 5 years |
| Percentage of Patients Who Are Free From Distant Metastases |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion of Women and Minorities
-Women and members of all races and ethnic groups are eligible for this trial. Because breast cancer occurs rarely in men, men will not be recruited for participation.
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| Name | Affiliation | Role |
|---|---|---|
| Imran Zoberi, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (HG-PBI) | Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (HG-PBI) | Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Patients Who Are Free of Serious Treatment Related Toxicity | Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
Adverse events and all-cause mortality was collected from start of treatment through completion of follow-up (up to 5 years).
Acute adverse events are defined as adverse events that occurred from start of treatment until day 90. Late adverse events are defined as adverse events that occurred from Day 91 until completion of 5 year follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (HG-PBI) - Acute | Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Imran Zoberi, M.D. | Washington University School of Medicine | 314-362-8610 | izoberi@wustl.edu |
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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 | Nov 26, 2019 | Jan 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| At 5 years |
| Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. For the global health and five functional scales (Cognitive Functioning, Emotional Functioning, Physical Functioning, Role Functioning, and Social Functioning) a high score correlates to a high level of functioning or a better outcome. For the three symptom scales and six single item scales (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea, Financial Difficulties) a high score correlates to high levels of symptoms or problems and a worse outcome. | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 |
| Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. For the four symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms) a high score correlates to high levels of symptoms or problems and a worse outcome. For the four functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) a high score correlates to a high/healthy level of functioning or a better outcome | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 |
| Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor (0) and "severe pain" at (10) with the patient's mark providing a range of scores from 0-100 millimeters. A higher score indicates greater pain intensity. | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 |
| Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 |
| Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. This is calculated from dividing the BRA score by the reference length from sternal notch to contralateral nipple and then multiplying that value by 100 to get a percentage. | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 |
| Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | Using this scale, cosmesis is qualitatively evaluated by the treating radiation oncologist by comparing the treated breast with the contralateral breast using the Aronson Modified Scale. The global cosmetic result, appearance of the surgical scar, breast size, breast shape, skin color, location of the areola and nipple, and shape of the areola and nipple were scored on a 4-point scale. In this case 1 is 'excellent' with 4 being 'poor.' | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 |
| Number of Patients With Complications Using CTCAE v. 4.0 | Acute complications are defined as complications that occurred from start of treatment until day 90. Late complications are defined as complications that occurred from Day 91 until completion of 5 year follow-up. | Up to 5 years |
| Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0 | Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up. | Up to 5 years |
| Percentage of Patients Undergoing Mastectomy on the Treated Side | At 5 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast | Percentage of patients without ipsilateral breast tumor recurrences (IBTR). | Posted | Count of Participants | Participants | At 5 years |
|
|
|
| Secondary | Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes | Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups. | Posted | Count of Participants | Participants | At 5 years |
|
|
|
| Secondary | Percentage of Patients Who Are Free From Distant Metastases | Posted | Count of Participants | Participants | At 5 years |
|
|
|
| Secondary | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. For the global health and five functional scales (Cognitive Functioning, Emotional Functioning, Physical Functioning, Role Functioning, and Social Functioning) a high score correlates to a high level of functioning or a better outcome. For the three symptom scales and six single item scales (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea, Financial Difficulties) a high score correlates to high levels of symptoms or problems and a worse outcome. | If participants did not complete the questionnaire or did not complete a question then they are not included in the number analyzed. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 |
|
|
|
| Secondary | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. For the four symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms) a high score correlates to high levels of symptoms or problems and a worse outcome. For the four functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) a high score correlates to a high/healthy level of functioning or a better outcome | If participants did not complete the questionnaire or did not complete a question then they are not included in the number analyzed. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 |
|
|
|
| Secondary | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor (0) and "severe pain" at (10) with the patient's mark providing a range of scores from 0-100 millimeters. A higher score indicates greater pain intensity. | If participants did not complete the questionnaire then they are not included in the number analyzed. | Posted | Mean | Standard Deviation | mm | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 |
|
|
|
| Secondary | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. | If participants missed the BRA then they are not included in the number analyzed. | Posted | Mean | Standard Deviation | cm | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 |
|
|
|
| Secondary | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. This is calculated from dividing the BRA score by the reference length from sternal notch to contralateral nipple and then multiplying that value by 100 to get a percentage. | If participants did not have the percentage Breast Retraction Assessment then they are not included in the analysis. | Posted | Mean | Standard Deviation | percentage breast retraction | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 |
|
|
|
| Secondary | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | Using this scale, cosmesis is qualitatively evaluated by the treating radiation oncologist by comparing the treated breast with the contralateral breast using the Aronson Modified Scale. The global cosmetic result, appearance of the surgical scar, breast size, breast shape, skin color, location of the areola and nipple, and shape of the areola and nipple were scored on a 4-point scale. In this case 1 is 'excellent' with 4 being 'poor.' | If physicians did not complete the evaluation with the participant then they are not included in the number analyzed. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 |
|
|
|
| Secondary | Number of Patients With Complications Using CTCAE v. 4.0 | Acute complications are defined as complications that occurred from start of treatment until day 90. Late complications are defined as complications that occurred from Day 91 until completion of 5 year follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0 | Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Percentage of Patients Undergoing Mastectomy on the Treated Side | Posted | Count of Participants | Participants | At 5 years |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 32 |
| 50 |
| EG001 | Treatment (HG-PBI) - Late | Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. | 4 | 50 | 0 | 50 | 48 | 50 |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Poor dentition | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| COVID-19 infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Candida infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Joint infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Shingles | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Scar retraction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Irritability | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast atrophy | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nipple deformity | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin atrophy | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombotic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
|
| Cognitive Functioning |
|
|
| Constipation |
|
|
| Diarrhea |
|
|
| Dyspnea |
|
|
| Emotional Functioning |
|
|
| Fatigue |
|
|
| Financial Difficulties |
|
|
| Global Health Status |
|
|
| Insomnia |
|
|
| Nausea and Vomiting |
|
|
| Pain |
|
|
| Physical Functioning |
|
|
| Role Functioning |
|
|
| Social Functioning |
|
|
|
| Body Image |
|
|
| Breast Symptoms |
|
|
| Future Perspective |
|
|
| Sexual Enjoyment |
|
|
| Sexual Functioning |
|
|
| Systemic Therapy Side Effects |
|
|
| Upset by Hair Loss |
|
|
| Anemia |
|
| Arthralgia |
|
| Ataxia |
|
| Atrial Fibrillation |
|
| Back Pain |
|
| Breast Atrophy |
|
| Breast Pain |
|
| Bronchial Infection |
|
| Congestive heart failure |
|
| Chest pain - Cardiac |
|
| Chest Wall Pain |
|
| Chills |
|
| Chronic kidney disease |
|
| Constipation |
|
| Cough |
|
| Depression |
|
| Diarrhea |
|
| Dizziness |
|
| Dry Mouth |
|
| Dry Skin |
|
| Dyspnea |
|
| Edema Limbs |
|
| Ejection fraction decreased |
|
| Epistaxis |
|
| Fall |
|
| Fatigue |
|
| Fibrosis deep connective tissue |
|
| Flank Pain |
|
| Gastroesophageal reflux disease |
|
| Poor dentition |
|
| Headache |
|
| Heart Failure |
|
| Hematoma |
|
| Hot Flashes |
|
| Hyperhidrosis |
|
| Hyperkalemia |
|
| Hypertension |
|
| Candida infection |
|
| COVID-19 infection |
|
| Insomnia |
|
| Irritability |
|
| Joint infection |
|
| Memory Impairment |
|
| Shoulder pain |
|
| Myocardial Infarction |
|
| Nausea |
|
| Neck Pain |
|
| Neutrophil Count Decreased |
|
| Nipple deformity |
|
| Pain in extremity |
|
| Pain |
|
| Pericardial Effusion |
|
| Platelet Count decrease |
|
| Seroma |
|
| Skin Atrophy |
|
| Skin Hyperpigmentation |
|
| Skin Induration |
|
| Skin Infection |
|
| Superficial soft tissue fibrosis |
|
| Telangiectasia |
|
| Thrombotic event |
|
| Tremor |
|
| Upper respiratory Infection |
|
| Urticaria |
|
| Vaginal Pain |
|
| Vertigo |
|
| Vomiting |
|
| White blood cell decrease |
|
| Shingles |
|
| Scar retraction |
|
| Trigger finger |
|
| Title | Measurements |
|---|
|