Susan Persky, Ph.D.

This study is part of an effort to learn about interactions between doctors and patients. The study will use virtual reality technology to examine how patients and doctors interact when they discuss disease risks.

Men and women between the ages of 25 and 40 who have access to the Internet and were born and raised in the United States may be eligible for this study. Participants will be recruited from the Washington D.C. area.

Participants undergo the following procedures:

* Complete an online questionnaire about their health-related background, family health history, cancer risk perceptions, and demographic information (e.g., age, marital status, education, etc.).
* Participate in activities in a virtual reality environment in which they interact with a virtual doctor in a virtual clinical scenario. For this experiment, participants wear a head-mounted display that allows them to see the virtual world images.
* Fill out a second questionnaire after completing the virtual reality activities. This questionnaire includes information on the participants virtual reality experience, the information provided in the experience, and questions about themselves and their background.

This study will investigate interactions between doctors and patients regarding risks of common, complex diseases using virtual reality technology.

Men and women between the ages of 25 and 40 who have access to the Internet and were born and raised in the United States may be eligible for this study. Participants will be recruited from the Washington D.C. area.

Study subjects complete two phases. The first phase is to complete an online questionnaire about their heath-related background, family health history, cancer risk perceptions, and demographic information using a secure survey website. The second phase involves interacting with a virtual doctor in a virtual environment clinical scenario, followed by completion of a second questionnaire. While in the virtual environment, participants wear a head-mounted video unit that allows them to see elements of the environment. The activities in the virtual environment take about 15 minutes. The total time for the study is about 60 minutes.

Reactions to Disease Risk Information

Participant Reactions to Disease Risk Information

The objective of the proposed study is to examine a cognitive bias known as anchoring and adjustment that may occur during provider-patient interactions, such as during provision of risk information for common, complex diseases that have both genetic and behavioralcomponents.

National Human Genome Research Institute (NHGRI)

Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases

Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis of the involved spinal bone metastases

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions of the involved spinal bone metastases

Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis of the involved spinal bone metastases

Harald Rief, MD, PhD

Jürgen Debus, MD, PhD

The primary goal of the study is to determine the local control-rate after radiotherapy (RT) with and without simultaneous integrated boost (SIB) concepts in patients with bone metastases of the spine. Further study objectives are survival, and clinical parameters such as pain, quality of life (QoL) and fatigue. We expect an improvement in local control and consecutively an increased re-sclerotization of the bone metastasis due to a higher biological dose in the tumor area. Therefore patients could benefit in quality-of-life, pain relief and mobility.

The vertebral column is the main localization of bone metastases and is where they frequently indicate an advanced stage of a malignant primary disease \[1, 2\]. Two thirds of all patients with tumors are estimated to develop bone metastases in the course of their disease \[3\]. Spinal bone metastases are of central impact for patients in a palliative setting. The clinical symptoms include pain at rest and under exercise but also impaired activity of daily life, the risk of pathological fractures, and neurological deficits. Local control is the essential factor for stability of the vertebral body of patients with spinal bone metastases. In regard to re-calcification of former osteolytic lesions, palliative radiotherapy (RT) represents an effective treatment option \[4\]. The most common schedule was specified as 30 Gy in 10 fractions. Stereotactic body radiation therapy (SBRT) using intensity-modulated radiotherapy (IMRT) can be a safe modality for treating spinal metastasis with enhanced targeting accuracy \[5\]. Secondly, IMRT to the spine was well tolerated (especially in the spinal cord), had no significant late toxicities, and spared other organs at risk simultaneously \[6\]. The main problem of the standard schedule is the limited dose application to the metastasis due to organ at risk myelon. Therefore, the aims of this study is to apply a high biological dose in the tumor region and to achieve an improved result related to local control for palliative patients with painful spinal bone metastases. Secondly, the aim is to evaluate QoL, fatigue, and survival of three different RT-techniques. To the best of our knowledge, no comparable randomized study has been described in the literature so far.

Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases

local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine

PFS is assessed 2 years post completion of radiotherapy

pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation

Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment

Fatigue is assessed using the EORTC FA13 questionnaire

Heidelberg University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Capecitabine

Letrozole

Albumin-Bound Paclitaxel

Goserelin

Pertuzumab

Androgen Receptor Antagonists

6 cycles of Paclitaxel,Carboplatin, Herceptin and Pertuzumab treatment with a good clinical benefit response depending on HR/HER-2 status.

2 cycles of Paclitaxel,Carboplatin, Herceptin treatment with a good clinical benefit response depending on HR/HER-2 status following surgery

If patients were HR+ and HER2- without PI3K-AKT pathway mutation

If patients were HR+ and HER2- with PI3K-AKT pathway mutation

If patients were HR+ and HER2+ without PI3K-AKT pathway mutation

If patients were HR+ and HER2+ with PI3K-AKT pathway mutation

If patients were HR- and HER2+ without PI3K-AKT pathway mutation

If patients were HR- and HER2+ with PI3K-AKT pathway mutation

If patients were HR- and HER2- with LAR subtype

HR+ and HER2-; No correlated pathway variation

TNBC with Homologous Recombination Repair Defect (HRD)

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles.

Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles.

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off) oral letrozole 2.5 mg daily； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); Alpelisib 300mg PO QD； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off) oral letrozole 2.5 mg daily； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

CLH1

Drug:

oral letrozole 2.5 mg daily; Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

CLH2

Drug:

pyrotinib(EGFR-TKI) 400mg qd； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； capecitabine 1000mg/m2 bid(d1-d14)

Drug:

Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W.

Drug:

SHR6390（CDK4/6 inhibitor）125 mg po.qd(three week on one week off) SHR3680（AR inhibitor）240 mg po. qd.

SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); oral letrozole 2.5 mg daily； Adebrelimab was given intravenously, 600mg each time, once every 2 weeks; Premenopause：Goserelin 3.6mg IM IM Q4W.

Famitinib 20mg orally once daily; Albumin paclitaxel 100mg/ m2, i.v.; Combined carboplatin AUC=2, i.v.; d1, 8, 15,21 days a cycle, a total of 4 cycles.

Fluzoparil 150mg orally twice daily; Famitinib 20mg orally once daily;

Adebrelimab was administered intravenously, 600mg each time, once every 2 weeks; Famitinib 20mg once daily; Albumin paclitaxel 100mg/m2 qw intravenous drip (used for 3 weeks/stopped for 1 week), 28 days per treatment cycle;

Zhimin Shao, MD.PhD.

Zhimin Shao, PhD

This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.

A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC

This is a Phase Ib/II, Prospective , Open-label, Single Center, Bayesian Adaptive Design, Umbrella Study Evaluating the Efficacy and Safety of Neo-adjuvant Therapy in Patients With Breast Cancer.

pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.

ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reactions to Disease Risk Information	NCT00774254	Cancer	A B	25 Years - 40 Years	National Institutes of Health Clinical Center (CC)
Intensity-modulated Radiotherapy With Integrated-boost in Patients With Spinal Bone Metastases	NCT02832765	Vertebral Bony ...	A B C D	18 Years - 80 Years	Heidelberg University
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC	NCT04215003	Breast Cancer	A B CL1 CL2 CLH1 CLH2 CH1 CH2 CT1 CL4 CL3 CT2 CT3 CT4	18 Years - 70 Years	Fudan University
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC	NCT04215003	Breast Cancer	A B CL1 CL2 CLH1 CLH2 CH1 CH2 CT1 CL4 CL3 CT2 CT3 CT4	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for b

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Spots Global Cancer Trial Database for b

Every month we try and update this database with for b cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.