Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

FoundationOne CDx will be performed using archival tumor tissue

FoundationOne CDx

Seock-Ah Im, MD PhD

Breast cancer is the most common cancer in women worldwide, especially in developed countries. In developing countries, including South Korea, the incidence and mortality rate of breast cancer is rapidly increasing. One of the most important characteristics of breast cancer in South Korea, as well as in other Asian countries, is the younger onset of disease compared to Western.

Medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. However, data and knowledge are still limited in terms of molecular characteristics of Asian breast cancer, compared to that of Western countries, and this remains a major hurdle for drug development in Asian breast cancer patients.

The primary objective of this study is to elucidate the genetic characteristic of young (\<50 years of age) Korean patients with metastatic breast cancer using FoundationOne CDx.

Secondary Objective(s):

1. To evaluate the prognostic and predictive role of tumor mutation burden.
2. To reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including DNA damage repair (DDR) molecules and various immune modulating molecules including PD-L1, PD-1, IDO, and OX40).
3. Compare molecular characteristics of breast cancer according to age groups (\<35 years vs. 35-50 years).
4. To offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). In addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).

Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer

Molecular Profiling Using FoundationOne CDx in Young (<50 Years of Age) Patients With Metastatic Breast Cancer (ML41263)

Genetic characteristics will be evaluated using FoundationOne CDx.

Tumor mutation burden will be analysed using FoundationOne CDx.

FoundationOne CDx results and immunohistochemical expression will be analysed.

Genetic characteristics will be analysed according to age groups.

The result of FoundationOne CDx will be used in patient treatment

Seoul National University Hospital

Professor

All Drugs and Chemicals

Hormones

Rebecca Troisi, D.Sc.

International variation in breast cancer rates and data from migrant and animal studies support the possibility that exposures early in development, including the in utero period, play a role in breast carcinogenesis. One of the most striking prenatal influences on breast cancer risk is whether the woman was born in a country with a low or high breast cancer incidence. This observation has led to interest in the degree to which in utero exposures vary by the maternal environment, and to the hypothesis that alterations in prenatal concentrations of steroid hormones, particularly estrogens, and other biologic parameters to which the fetus is exposed mediate differences in subsequent breast cancer risk.

There are striking differences in breast cancer incidence rates between Asian and North American and Western European populations, but variation within Asia is also wide. Incidence in Mongolia is one of the lowest in the world (6.6/100,000) while China, its neighbor to the south, has about three times this rate (18.7/100,000). Furthermore, rates appear higher in urban than in rural areas. Over the last decade and a half Mongolia has experienced profound economic changes resulting in mass migration from a nomadic or semi-nomadic existence to a more western lifestyle in the capital city of Ulaanbaatar. Together with the contrast in exposures between traditional and urban settings, migration presents the opportunity to study women as they acculturate to a more western lifestyle.

We propose collecting maternal and cord blood samples from pregnant Mongolian women and their offspring living in rural and urban areas to describe concentrations of several steroid hormones and growth factors. The purpose of the study is to assess whether the in utero environment differs in women living a traditional lifestyle compared with a more urban lifestyle, and by degree of western acculturation among those who have recently migrated to the capital. Maternal and cord blood samples from an ongoing cohort study being conducted at the University of Pittsburgh will provide a comparison group of US women.

The National Cancer Institute has been conducting research in countries around the world with the purpose of documenting international differences in hormone and growth factor levels with the intent of trying to understand how these relate to health. In particular, recent evidence suggests that hormones and growth factors very early in life may affect later disease risk. Dr. Ganmaa, a native Mongolian physician and Harvard-trained scientist suggested including Mongolia as one of the research settings for the NCI multi-centered study since the country offers a distinct population with unique lifestyles and traditions.

Over the last decade and a half Mongolia has experienced profound economic changes resulting in mass migration from a nomadic or semi-nomadic existence to a more western lifestyle in the capital city of Ulaanbaatar. Together with the contrast in exposures between traditional and urban settings, migration presents the opportunity to study women as they acculturate to a more western lifestyle.

Mongolia provides a unique opportunity to assess whether differences in urban and rural lifestyles and behaviors influence health. The purpose of the study is to assess whether the pregnancy environment differs in women living a traditional lifestyle compared with a more urban lifestyle, and by degree of western acculturation among those who have recently migrated to the capital. We plan to compare steroid hormones and growth factors in maternal and cord blood samples from pregnant Mongolian women living in rural and urban areas with pregnant women from the US (at Brigham and Women's Hospital in Boston), UK (the Avon Longitudinal Study of Parents and Children), Norway (the Norwegian Mother and Child Cohort) and outside Beijing, China (CDC's randomized trial of pregnancy supplements).

Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women

Assess whether the in utero environment differed in women living a traditional lifestyle compared with a more urban lifestyle, and by degree of Western acculturation among those who had recently migrated to the capital. In addition, we planned to study the endocrine profile of pre-menopausal women living in UlaanBaatar by their migration status among mothers of girls participating in a study of milk consumption and hormonal status conducted by our collaborators at Harvard Medical School. Reproductive hormones were measured and are being compared to those in women living in the UK.

National Cancer Institute (NCI)

Bone Density Conservation Agents

Antineoplastic Agents

Tamoxifen

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen

Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen

Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization

Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

Surgery: Oophorectomy

Richard R. Love, M.D.

This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.

Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer

International Breast Cancer Research Foundation

Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

A - Scheduled Surgery

Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

B - Immediate Surgery

Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

C- Immediate Surgery - Nonrandomized

Total

Age, Continuous

Sex: Female, Male

Positive

Negative

Estrogen receptor status

Progesterone receptor status

HER2/Neu status

None

Number of positive axillary nodes

Pathologic tumor size

2-4.99

Progesterone level on day of surgery (ng/ml)

Baseline measures were not available on all participants.

Richard R. Love

Disease-free Survival

Overall Study

Digestive System Diseases

Mouth and Tooth Diseases

Wounds and Injuries

Dermatitis

Head and Neck Neoplasms

Mucositis

Radiodermatitis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Ling-Wei Wang, MD

The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

* One-site audit. The enrolled subject is confirmed by PIs

  ◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.
* NCI CTCAE v5.0 for AE records
* Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent
* Sample size assessment: 60 subjects will be included in one year for total 120 subjects
* Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
* Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p \< 0.05 is suggested significant.

ALDH2 Mutation in Taiwanese Head and Neck Cancer

Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer

The side effects of each participant will be recorded accoiding to CTCAEv5.0 during the whole course of chemoradiation, by indicated physicians regularly

Taipei Veterans General Hospital, Taiwan

Herbal and Botanical

Soy Bean

Participants will be asked to increase soy in their diet by an equivalent of 50mg/day for 12 months

Participants will consume 2 tablets of 50mg each per day for 12 months

Soy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods.

Dietary soy

Soy isoflavones delivered in extracted form

Soy Supplement

Soo Hwang Teo

Globally, breast cancer is the most common cancer and the main cause of deaths due to cancer. This is attributed to changes in reproductive habits as well as an increasingly sedentary lifestyle, with low physical activity and diets rich in saturated fats but low in fiber. While the main focus in many Asian countries is to improve survival from breast cancer by encouraging early detection of the disease and improving access to cancer treatment, it does not reduce the number of women who will be diagnosed with breast cancer in the years to come. Currently, there is an urgent need to develop effective strategies to prevent breast cancer in Asia and beyond.

Soy may be an important dietary strategy for breast cancer prevention. Compared to women in the West, Asian women consume up to 10-fold more soy in their diet, which may, in part, explain their lower risk of breast cancer. Soybeans are rich in isoflavones, which can mimic estrogenic activity. In the body, it competes with estrogen and binds to estrogen receptor sites, thereby reducing the effect of estrogen and possibly lowering breast cancer risk.

Consistently, research has shown that Asian postmenopausal women who have high soy diets are less likely to be diagnosed with breast cancer. However, researchers have not been able to show that postmenopausal women can reduce their breast cancer risk by increasing soy intake as part of their diets. There are several reasons why these studies have failed to see an effect despite the body of evidence indicating that soy may be protective. Firstly, these are studies of Caucasian women who may have never been exposed to soy, particularly in adolescence, where soy may have the greatest impact. Also, these studies have used soy isoflavone supplements, rather than traditional soy foods made from whole soybeans, which may affect how soy is metabolized in the body. Lastly, the way in which mammographic density measurements were obtained previously could have negatively influenced the study results, such as the use of digitized images of mammogram films rather than raw digital images and the use of semi-automated methods that may be subject to human error and reader variability.

Therefore, a well-designed intervention study among Asian women living in Asia, using suitable mammographic density measures as a surrogate marker of breast cancer risk, will best answer these remaining gaps in our knowledge about the soy-breast cancer relationship.

The Malaysian Soy and Mammographic Density Study

The Malaysian Soy and Mammographic Density (MiSo) Study: A Randomized, Three-arm, Controlled Clinical Trial to Investigate the Impact of Soy Isoflavone Intake on Mammographic Density as a Biomarker of Breast Cancer Risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer	NCT04098640	Breast Cancer	FoundationOne C...	19 Years - 50 Years	Seoul National University Hospital
Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women	NCT01160549	Pregnancy		18 Years - 50 Years	National Institutes of Health Clinical Center (CC)
Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer	NCT04098640	Breast Cancer	FoundationOne C...	19 Years - 50 Years	Seoul National University Hospital
Molecular Profiling in Young (<50 Years of Age) Patients With Metastatic Breast Cancer	NCT04098640	Breast Cancer	FoundationOne C...	19 Years - 50 Years	Seoul National University Hospital
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer	NCT00201851	Breast Cancer	Tamoxifen Surgery: Oophor...	18 Years - 50 Years	International Breast Cancer Research Foundation
ALDH2 Mutation in Taiwanese Head and Neck Cancer	NCT02761408	Dermatitis Mucositis		21 Years - 70 Years	Taipei Veterans General Hospital, Taiwan
Study of Pregnancy Hormone Concentrations in Urban and Nomadic Mongolian Women	NCT01160549	Pregnancy		18 Years - 50 Years	National Institutes of Health Clinical Center (CC)
The Malaysian Soy and Mammographic Density Study	NCT03686098	Breast Cancer Mammographic De...	Dietary soy Soy Supplement	45 Years - 65 Years	Cancer Research Malaysia

Spots Global Cancer Trial Database for asian

Every month we try and update this database with for asian 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.

Spots Global Cancer Trial Database for asian

Every month we try and update this database with for asian 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 asian 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.