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D001943: Breast Neoplasms

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (13)


Name (Synonyms) Correlation
drug3057 Screening digital breast tomosynthesis Wiki 0.45
drug3971 modification of the planned therapeutic management Wiki 0.45
drug3058 Screening digital mammography Wiki 0.45
Name (Synonyms) Correlation
drug1329 Flexitouch Plus with Cellular Connectivity (FT-CC) Wiki 0.45
drug1326 Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC) Wiki 0.45
drug1783 Ketotifen 1 MG Wiki 0.45
drug790 Cholecalciferol Wiki 0.45
drug785 Chlorpromazine Wiki 0.45
drug789 Choices and judgements Wiki 0.45
drug2626 Pre-operative breast magnetic resonance imaging Wiki 0.45
drug1043 Diagnostic mammography Wiki 0.45
drug3056 Screening breast magnetic resonance imaging Wiki 0.45
drug784 Chloroquine phosphate Wiki 0.26

Correlated MeSH Terms (8)


Name (Synonyms) Correlation
D014594 Uterine Neoplasms NIH 0.45
D014625 Vaginal Neoplasms NIH 0.45
D000072656 Breast Cancer Lymphedema NIH 0.45
Name (Synonyms) Correlation
D014846 Vulvar Neoplasms NIH 0.45
D008209 Lymphedema NIH 0.45
D002583 Uterine Cervical Neoplasms NIH 0.32
D010051 Ovarian Neoplasms NIH 0.26
D009369 Neoplasms, NIH 0.08

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0003002 Breast carcinoma HPO 1.00
HP:0100650 Vaginal neoplasm HPO 0.45
HP:0030416 Vulvar neoplasm HPO 0.45
Name (Synonyms) Correlation
HP:0010784 Uterine neoplasm HPO 0.45
HP:0001004 Lymphedema HPO 0.45
HP:0030079 Cervix cancer HPO 0.32
HP:0100615 Ovarian neoplasm HPO 0.32
HP:0002664 Neoplasm HPO 0.09

Clinical Trials

Navigate: Correlations   HPO

There are 5 clinical trials


1 Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density

This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.

NCT02980848
Conditions
  1. Breast Cancer
Interventions
  1. Other: Screening digital mammography
  2. Other: Screening digital breast tomosynthesis
  3. Other: Screening breast magnetic resonance imaging
  4. Other: Diagnostic mammography
  5. Other: Pre-operative breast magnetic resonance imaging
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

Primary Outcomes

Description: Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens

Measure: Screening Benefits: Rate of early stage invasive cancer detection (Aim 1)

Time: Within one year after screen

Description: Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens

Measure: Screening Failures: Interval or advanced breast cancer rate (Aim 1)

Time: Within one year after screen

Description: Number of positive screens divided by total number of screens

Measure: Screening Harms: Recall rate (Aim 1)

Time: Within one year after screen

Description: Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens

Measure: Screening Harms: False-positive (FP) recall rate (Aim 1)

Time: Within one year after screen

Description: Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens

Measure: Screening Harms: FP biopsy recommendation rate (Aim 1)

Time: Within one year after screen

Description: Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade

Measure: Screening Harms: Other consequences (Aim 1)

Time: Within one year after screen

Description: Patient surveys targeted to determining outcomes of interest to patients

Measure: Patient Reported Outcomes (Aim 1)

Time: Measured within one year post-screening

Description: Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women

Measure: Rates of additional breast cancers detected (Aim 2)

Time: 6 months after initial diagnosis

Description: Rate of 2nd breast cancers diagnosed within 3 years of follow-up (starting 6 months after initial diagnosis) calculated separately for ipsilateral and contralateral cancers

Measure: 3-year rate of 2nd breast cancer events (Aim 2)

Time: 3 years after initial diagnosis

Description: Patient surveys targeted to determining outcomes of interest to patients

Measure: Patient Reported Outcomes (Aim 2)

Time: Measured 6-18 months post-diagnosis

Secondary Outcomes

Description: Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases

Measure: Performance Measures: Sensitivity (Aim 1)

Time: Within one year after screen

Description: Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer

Measure: Performance Measures: Specificity (Aim 1)

Time: Within one year after screen

Description: Number of cancer cases within 1 year of positive screen divided by number of positive screens

Measure: Performance Measures: Positive predictive value (Aim 1)

Time: Within one year after screen

Description: Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction

Measure: Definitive surgery type (Aim 2)

Time: 6 months after initial diagnosis

Description: Number of women with a negative pre-operative MRI and no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women with a negative pre-operative MRI

Measure: Negative predictive value of work-up with MRI (Aim 2)

Time: 6 months after initial diagnosis

Description: Number of women without a pre-operative MRI with no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women without a pre-operative MRI

Measure: Negative predictive value of work-up without MRI (Aim 2)

Time: 6 months after initial diagnosis

Description: Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies

Measure: Core biopsy rates (Aim 2)

Time: 6 months after initial diagnosis

Description: Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies

Measure: Surgical biopsy rate (Aim 2)

Time: 6 months after initial diagnosis

Description: Number of initial benign biopsies over number of breast biopsies

Measure: Benign biopsy rate (Aim 2)

Time: 6 months after initial diagnosis

Other Outcomes

Description: Breast cancers deaths averted estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

Measure: Modeled Long-Term Mortality Outcome: Breast cancers deaths averted (Aim 1)

Time: From date of first screening examination until the date of death from any cause, up to 100 years of age

Description: Life-years gained estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

Measure: Modeled Long-Term Mortality Outcome: Life-years gained (Aim 1)

Time: From date of first screening examination until the date of death from any cause, up to 100 years of age

Description: Overdiagnosis estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

Measure: Modeled Long-Term Mortality Outcome: Overdiagnosis (Aim 1)

Time: From date of first screening examination until the date of death from any cause, up to 100 years of age
2 Impact of the COVID-19 Pandemic on Changes in Therapeutic Strategies in Gynecological Oncology

The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

NCT04351139
Conditions
  1. Gynecologic Cancer
  2. Breast Neoplasm Female
  3. Uterine Neoplasms
  4. Ovarian Neoplasms
  5. Uterine Cervical Neoplasms
  6. Vulvar Neoplasms
  7. Vaginal Neoplasms
Interventions
  1. Other: modification of the planned therapeutic management
MeSH:Neoplasms Breast Neoplasms Ovarian Ovarian Neoplasms Uterine Cervical Neoplasms Uterine Neoplasms Vulvar Neoplasms Vaginal Neoplasms
HPO:Breast carcinoma Cervical polyp Cervix cancer Neoplasm Neoplasm of the breast Ovarian neoplasm Uterine neoplasm Vaginal neoplasm Vulvar neoplasm

Primary Outcomes

Description: modification of the planned therapeutic management

Measure: percentage of patients with a change in the planned therapeutic management (surgery, chemotherapy, radiotherapy, hormone therapy)

Time: Day O
3 An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

This single arm, multicenter study provides the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who are currently receiving pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV). The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 400 participants with HER2+ breast cancer who have completed concurrent chemotherapy with P+H IV and are currently receiving or will be receiving maintenance therapy with pertuzumab and trastuzumab. Participants will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity or participant withdrawal. Only participants with HER2+ early breast cancer will receive PH FDC SC to complete 18 cycles of dual blockade, including the P+H IV they received prior to enrolling in this study. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

NCT04395508
Conditions
  1. HER2-positive Breast Cancer
Interventions
  1. Drug: Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC)
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

4 A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)

The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.

NCT04432727
Conditions
  1. Breast Cancer Lymphedema
Interventions
  1. Device: Flexitouch Plus with Cellular Connectivity (FT-CC)
MeSH:Breast Neoplasms Lymphedema Breast Cancer Lymphedema
HPO:Breast carcinoma Lymphedema Neoplasm of the breast

Primary Outcomes

Description: Compare the rate of compliance (defined as the number of days device used/total study days) in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.

Measure: Compliance

Time: Changes between 30 days after device training and 60 days after device training

Secondary Outcomes

Description: Comparison of partially compliant and compliant arm girth in patients treated with FT-CC. Arm girth is measured in cm.

Measure: Change in Arm Girth

Time: Changes between baseline, 30 days after device training, and 60 days after device training

Description: Comparison of partially compliant and compliant quality of life in patients treated with FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM). Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.

Measure: Quality of Life Assessment via LYMQOL ARM

Time: Changes between baseline, 30 days after device training, and 60 days after device training

Description: Comparison of partially compliant and compliant quality of life in patients treated with FT-CC by via The RAND 36-Item Short Form Survey (SF-36). The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.

Measure: Quality of Life Assessment via SF-36

Time: Changes between baseline, 30 days after device training, and 60 days after device training

Description: Comparison of partially compliant and compliant symptoms in patients treated with FT-CC by via The Lymphedema Symptom Intensity and Distress Survey-ARM (LSIDS-A). The Lymphedema Symptom Intensity and Distress Survey is a questionnaire used to assess intensity and distress of symptoms in patients with lymphedema of the arm. This includes sub-scores for soft tissue sensation (range 0-10), neurological sensation (0-10), function, (0-10), biobehavioral (0-10), resource (0-10), sexuality (0-10), activity (0-10). Higher score represents worse outcome.

Measure: Symptoms Assessment via LSIDS-A

Time: Changes between baseline, 30 days after device training, and 60 days after device training
5 Ketotifen: Novel Use as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy as Well as the Potential Beneficial Effects of Ketotifen in the Hypothetical Management of COVID-19

The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).

NCT04435028
Conditions
  1. Breast Cancer
  2. Iron Chelation
Interventions
  1. Drug: Ketotifen 1 MG
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

Primary Outcomes

Description: the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done

Measure: prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines

Time: 6 months

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook