Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Paclitaxel (Drug); Radiation therapy (Radiation)
Phase: Phase 2
Status: Recruiting
Sponsored by: New York University School of Medicine Official(s) and/or principal investigator(s): Silvia C Formenti, M.D., Principal Investigator, Affiliation: NYU Langone Medical Center
Overall contact: Silvia C Formenti, M.D., Phone: (212) 731-5039, Email: silvia.formenti@nyumc.org
Summary
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.
Clinical Details
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
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Test the clinical effectiveness of concurrent paclitaxel and radiation in a multiethnic cohort
Secondary outcome: Measure the pathological response rate of concurrent paclitaxel-radiationPerform molecular biology and genomic studies of obtained core biopsies to identify biomarkers for predisposition to breast cancer Patient demographics
Detailed description:
The term ―locally advanced breast cancer (LABC) commonly includes tumors whose maximum
diameter is 5 cm (T3) or larger, or which present with involvement of the chest wall or
skin. Surprisingly, the simultaneous presence of clinically detectable distant metastases is
relatively infrequent (~8%), a peculiar finding since in 73% of these large tumors it is
possible to document shedding of tumor cells into the blood.
While LABC has become a rare clinical presentation of breast cancer in the general
population as a result of improved early detection by mammographic screening, it remains
relatively common among minority women of low socioeconomic status. For instance, in a
consecutive series of 363 African-American women presenting in a large urban hospital, one
out of three women newly diagnosed with breast cancer had LABC.
It is well documented that although the incidence of breast cancer among African-Americans
is lower than among white women, breast cancer mortality in African-Americans is
significantly higher. In 1998, the American Cancer Society, the National Cancer Institute
and the Centers for Disease Control and Prevention reported an overall downward trend in
cancer incidence and mortality between 1990 and 1995 for all cancers combined. Many minority
and medically underserved populations, however, did not share equally in these improvements.
These patients have continued to encounter multifactorial barriers to early detection and
care, warranting interventions to improve access.
At the same time, it is equally important to offer the best chance for survival to those
underserved women who have already availed themselves of medical care. Paradoxically, while
the medical community is aware of the inadequate accrual of minority patients to clinical
trials, only few trials exist for LABC.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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)
Locations and Contacts
Silvia C Formenti, M.D., Phone: (212) 731-5039, Email: silvia.formenti@nyumc.org
NYU Langone Medical Center, New York, New York 10016, United States; Recruiting Silvia C Formenti, M.D., Phone: 212-731-5039, Email: silvia.formenti@nyumc.org Ravi Kathirithamby, MBA, Phone: (212) 731-5335, Email: ravindran.kathirithamby@nyumc.org
Additional Information
Starting date: March 2005
Last updated: June 3, 2015
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