Breast Cancer Clinical Trial
Official title:
Response, Resistance and Metastasis of Locally Advanced Breast Cancer (LABC, Stage 2B-3C) in a Multiethnic Cohort: A Phase II International Multicentric Study of Concurrent Paclitaxel and Radiation
NCT number | NCT02280252 |
Other study ID # | 06-209 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2005 |
Est. completion date | December 20, 2018 |
Verified date | November 2020 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The need to understand LABC is especially compelling in populations and countries with limited resources, where breast cancer incidence is relatively low, but mortality is comparably high. In these settings access to appropriate cancer care is characteristically limited or often plainly nonexistent. In contrast to economically developed nations, where on average fewer than 20% of women present with breast cancer at advanced stages, LABC and metastatic disease are the most common stages at presentation in 50% or more women in Latin America, Asia and Africa.
Status | Completed |
Enrollment | 69 |
Est. completion date | December 20, 2018 |
Est. primary completion date | December 20, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Biopsy proven locally-advanced breast cancer: IIB, IIIA, and IIIB - Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes - Measureable disease required - Adequate laboratory values: Hgb > 10 ANC > 1500 Platelets > 150,000 Creatinine < 1.5 Liver function < 3x normal - Patient = 18 years of age - Medically and psychologically able to comply with all study requirements - ECOG performance score 0-1 - CT chest, abdomen, and pelvis performed - Mammogram or USG performed - Signed informed consent Exclusion Criteria: - Breast cancer patients with Stage 0, Stage I, or Stage IIA - Previous XRT or chemotherapy - Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes - Pregnancy - Inflammatory breast cancer - Patients under treatment (or who will have recently been treated) with anti-neoplastic, immunosuppressive or hormonal medications - Patients who are found to have a cancer positive for the marker HER-2/neu (applies only to NYU Tisch and Bellevue sites) |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort | Test the effectiveness of concurrent paclitaxel and radiation in a prospective multiethnic cohort of patients with newly diagnosed stage 2B-3C breast cancer treated at three international academic centers under uniform conditions. Local recurrence, regional recurrence and overall survival will be measured | 4.5 years | |
Secondary | Measure the Pathological Response Rate of Concurrent Paclitaxel-radiation | Measure the pathological response rate to concurrent paclitaxel-radiation at each collaborating institution and compare it to that achieved in a previous Phase I-II trial | 4.5 years | |
Secondary | Perform Molecular Biology and Genomic Studies of Obtained Core Biopsies to Identify Biomarkers for Predisposition to Breast Cancer | Obtain core biopsies of the original tumor before and after treatment (from the surgical specimen) for molecular biology and genomic studies of biomarkers and genetic anomalies that may signal a population's predisposition to breast cancer and/or susceptibility to study intervention | 4.5 years | |
Secondary | Patient Demographics | Acquire descriptive information on patient epidemiological, cultural and behavioral characteristics | 4.5 years |
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