(Enter 1 to 5 Items) Clinical Trial
Official title:
Pilot Study of Breast Cancer Registry in Thailand
| Verified date | February 2012 |
| Source | Siriraj Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical Committee |
| Study type | Observational |
Breast cancer is the most common malignancy affecting women. It is the second leading cause
of cancer related death in women in many parts of the world. Breast cancer also occurs in
men, accounting for nearly 1% of the total incidence. As a result of continuing research
into new treatment methods, women and men with breast cancer now have more treatment
options, and a better chance of long-term survival than ever before.
The primary treatment for breast cancer is surgery. Early stage breast cancer, defined for
the purposes of this registry as newly diagnosed, clinical stage I to IV breast cancer with
no prior therapy for current disease, is often curable with surgery alone. Reports from the
National Surgical Adjuvant Breast and Bowel Project (NSABP) and the European Organization
for Research and Treatment of Cancer (EORTC) longitudinal trials have explored the efficacy
of various surgical techniques as primary treatment of early stage breast cancer1-7. These
studies include 20 years of follow-up data that have not shown any significant differences
in overall survival or in rates of distant recurrences in women who underwent
breast-conserving surgery with radiation therapy versus those who underwent mastectomy. The
results of these studies have supported the use of surgery as the standard breast cancer
treatment practice around the world.
Data have shown that regardless of the surgical procedure selected for the removal of the
primary tumor, micrometastases may be present and lead to the development of disease
relapse. In order to decrease the risk of recurrence, patients may receive various
therapies. Systemic treatments include chemotherapy and hormonal therapy. Local treatment,
such as radiotherapy, can also be used to eliminate malignant cells that remain in the
breast, chest wall, or lymph nodes after surgery.
The selection of systemic therapy is a complex process, which is based partly on prognostic
factors such as lymph node status, and predictive factors such as hormone receptor status. A
number of additional factors are emerging such as HER2/neu overexpression8-10, p53 status,
histological evidence of vascular invasion, and quantitative parameters of angiogenesis, but
these await confirmation by further research11. However, patient age, socioeconomic status,
and availability of treatment options are among a number of other factors that may play a
role in determining the type of therapy that a patient is offered.
Over the years, results from a large number of clinical trials have led to the development
of various guidelines for breast cancer therapy, including the Early Breast Cancer Trialists
Group (EBCTG) conferences in 199512 and 200013, the 2000 National Institutes of Health (NIH)
Consensus Conference14, and the 8th St Gallen meeting in 200315. Despite the overview
analyses and consensus recommendations, detailed information is lacking regarding the actual
use of the currently available breast cancer treatments. Furthermore, the reasons that
patients and physicians choose specific therapeutic regimens are not well understood.
With more than 1.2 million people worldwide diagnosed with breast cancer in 200116, and the
incidence predicted to increase, making appropriate treatment choices is critical to each
breast cancer patient's survival, well-being and quality of life. The plethora of available
scientific and lay information can result in a complex and arduous decision-making process
for the breast cancer patient and his/her health care provider(s). It is anticipated that
this registry will assist in the decision-making process by providing up-to-date information
about treatment patterns.
STUDY OBJECTIVES The purpose of the study is to collect, analyze, and disseminate data on
patients with stage I-IV breast cancer. The goal of this registry is to improve patients
care through a better understanding of treatment patterns and outcomes within individual
countries, geographic regions, and ultimately, worldwide.
Primary Objectives:
- Characterize the clinical pattern of patients with breast cancer (clinical stage I-IV
as defined by the AJCC17).
- Characterize existing and evolving practice patterns.
- Assess patient disease free and overall survival outcomes.
Secondary Objectives:
- Disseminate findings through publication in peer-reviewed scientific journals.
- Provide supportive data to the development of standard therapies.
- Analyze data and design ancillary studies to address unanswered clinical questions.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1. Male or Female > 18 years, 2. Newly diagnosed stage I-IV breast cancer which is defined to meets any one of the following clinical or pathological staging criteria (version 6.0 AJCC classification17) in Appendix B. 3. No prior therapy (other than surgery) for current disease, 4. Written informed consent (if required by local regulations). Exclusion Criteria: 1. Unable to receive definitive treatment 2. Unable to attend regular follow-up visit |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Siriraj Hospital | Bangkoknoi | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Siriraj Hospital |
Thailand,