Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments paclitaxel, radiation therapy
Phase phase 2
Sponsor New York University School of Medicine
Start date March 2005
End date October 2015
Trial size 85 participants
Trial identifier NCT02280252, S06-209

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will be administered pre-operatively over 12 weeks either: Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7: Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)
paclitaxel Abraxane
Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.
radiation therapy radiotherapy
Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)

Primary Outcomes

Measure
Test the clinical effectiveness of concurrent paclitaxel and radiation in a multiethnic cohort
time frame: 4.5 years

Secondary Outcomes

Measure
Measure the pathological response rate of concurrent paclitaxel-radiation
time frame: 4.5 years
Perform molecular biology and genomic studies of obtained core biopsies to identify biomarkers for predisposition to breast cancer
time frame: 4.5 years
Patient demographics
time frame: 4.5 years

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Nelly Huppert, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.