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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent Paclitaxel and RT | Experimental | Patients will be administered pre-operatively over 12 weeks either:
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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Perform Molecular Biology and Genomic Studies of Obtained Core Biopsies to Identify Biomarkers for Predisposition to Breast Cancer |
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Inclusion Criteria:
Hgb > 10 ANC > 1500 Platelets > 150,000 Creatinine < 1.5 Liver function < 3x normal
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelly Huppert, M.D. | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
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The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
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| ID | Title | Description |
|---|---|---|
| FG000 | Concurrent Paclitaxel and RT | Patients will be administered pre-operatively over 12 weeks either:
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: 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: 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
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| ID | Title | Description |
|---|---|---|
| BG000 | Concurrent Paclitaxel and RT | Patients will be administered pre-operatively over 12 weeks either:
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: 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: 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available | Posted | 4.5 years |
|
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The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Concurrent Paclitaxel and RT | Patients will be administered pre-operatively over 12 weeks either:
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: 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: 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nelly Huppert | NYU Langone Health | (212) 731-5003 | Nelly.Huppert@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2016 | Oct 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Radiation therapy | Radiation | 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) |
|
|
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 |
| Patient Demographics | Acquire descriptive information on patient epidemiological, cultural and behavioral characteristics | 4.5 years |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Study-Specific Measure |
|
| 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 | The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available | Posted | 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 | The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available | Posted | 4.5 years |
|
|
| Secondary | Patient Demographics | Acquire descriptive information on patient epidemiological, cultural and behavioral characteristics | The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available | Posted | 4.5 years |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |