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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01194 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA013330 | U.S. NIH Grant/Contract | View source |
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Interventional component of study terminated prior to full enrollment
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies chemotherapy before surgery and tissue sample collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide, paclitaxel and trastuzumab may kill more tumor cells. Collecting and storing samples of tissue from patients with breast cancer to study in the laboratory may help doctors learn more about how well patients will respond to treatment.
PRIMARY OBJECTIVES:
I. To evaluate the effects of preoperative neoadjuvant paclitaxel and doxorubicin (doxorubicin hydrochloride)/cyclophosphamide (AC) on: senescence; invasion/motility (tumor microenvironment of metastasis [TMEM] and 67 kDa laminin receptor [67LR]).
II. To create a biospecimen repository for future studies derived from patients with breast cancer receiving standard neoadjuvant chemotherapy.
OUTLINE: Patients with human epidermal growth factor receptor 2 (HER2)-positive disease are assigned to Stratum A, and patients with HER2-negative disease are randomized to Stratum B or C.
STRATUM A: Patients receive paclitaxel intravenously (IV) over 1 hour and trastuzumab IV over 30-90 minutes weekly for 12 weeks. Beginning 2-3 weeks later, patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks
STRATUM B: Patients receive paclitaxel, doxorubicin hydrochloride, and cyclophosphamide as in Stratum A.
STRATUM C: Patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks.
Patients undergo surgery 2-6 weeks after the last chemotherapy dose.
In all arms, treatment continues in the absence of unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratum A: HER2-positive | Experimental | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. |
|
| Stratum B: HER2-negative | Experimental | Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A. |
|
| Stratum C: HER2-negative | Experimental | Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR | Descriptive statistics by treatment group will be presented. The two-sampled t-test will be performed. Appropriate transformation may be used to improve normality of the outcome variable. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quantitative Biomarker Levels in Patients With Chemotherapy-responsive and -Resistant Tumors, Including Senescence, Cell Death, TMEM, Mena, and 67LR | Paired T-test or Wilcoxon signed-rank test will be performed. Two-sample t-test will be performed to compare biomarker between the two groups. If the data are not normally distributed, a suitable data transformation such as the log or rank transformation will be applied. Logistic regression models will also be fit to the data with treatment sensitive/resistance category as the outcome and baseline as well as pre-post change in biomarker level as the main predictor variable to obtain estimates of odds ratios unadjusted and adjusted for potential confounders including patients characteristics. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Anampa, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28679654 | Background | Karagiannis GS, Pastoriza JM, Wang Y, Harney AS, Entenberg D, Pignatelli J, Sharma VP, Xue EA, Cheng E, D'Alfonso TM, Jones JG, Anampa J, Rohan TE, Sparano JA, Condeelis JS, Oktay MH. Neoadjuvant chemotherapy induces breast cancer metastasis through a TMEM-mediated mechanism. Sci Transl Med. 2017 Jul 5;9(397):eaan0026. doi: 10.1126/scitranslmed.aan0026. |
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31 patients were enrolled into the study however one patient screen failed prior to being randomized into one of the study strata.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stratum A: HER2-positive | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 11, 2021 |
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| Stratum I: HER2-negative |
| Experimental |
Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. |
|
| Stratum II: HER2-positive | Experimental | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. |
|
| Stratum III: ER2-positive, HER2-negative | Experimental | Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. |
|
|
| Cytology Specimen Collection Procedure | Other | Correlative studies |
|
|
| Doxorubicin Hydrochloride | Drug | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Paclitaxel | Drug | Given IV |
|
|
| Trastuzumab | Biological | Given IV |
|
|
| Endocrine therapy | Drug | Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. |
|
|
| Baseline to 8 weeks (2 courses) |
| FG001 | Stratum B: HER2-negative | Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| FG002 | Stratum C: HER2-negative | Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| FG003 | Stratum I: HER2-negative | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| FG004 | Stratum II: HER2-positive | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| FG005 | Stratum III: ER-Pos, HER2-negative | Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stratum A: HER2-positive | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG001 | Stratum B: HER2-negative | Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG002 | Stratum C: HER2-negative | Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG003 | Stratum I: HER2-negative | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG004 | Stratum II: HER2-positive | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG005 | Stratum III: ER-positive, HER2-negative | Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR | Descriptive statistics by treatment group will be presented. The two-sampled t-test will be performed. Appropriate transformation may be used to improve normality of the outcome variable. | Change in baseline to 6 month specimens for senescence, TMEM, mena, and 67LR biomarkers were not collected and analyzed. | Posted | Baseline to 6 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Changes in Quantitative Biomarker Levels in Patients With Chemotherapy-responsive and -Resistant Tumors, Including Senescence, Cell Death, TMEM, Mena, and 67LR | Paired T-test or Wilcoxon signed-rank test will be performed. Two-sample t-test will be performed to compare biomarker between the two groups. If the data are not normally distributed, a suitable data transformation such as the log or rank transformation will be applied. Logistic regression models will also be fit to the data with treatment sensitive/resistance category as the outcome and baseline as well as pre-post change in biomarker level as the main predictor variable to obtain estimates of odds ratios unadjusted and adjusted for potential confounders including patients characteristics. | Change in baseline to 8 week specimens for cell death, TMEM, mena, and 67LR biomarkers were not collected and analyzed. | Posted | Baseline to 8 weeks (2 courses) |
|
Adverse event data was collected up to 2-3 weeks post-treatment initiation in conjunction with biopsy collections, up to an overall period of 6-8 weeks total.
In accordance with the study protocol only adverse events data related to the biopsy were considered research-related and were identified for collection and reporting as part of the clinical study.
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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 | Stratum A: HER2-positive | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Stratum B: HER2-negative | Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Stratum C: HER2-negative | Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Stratum I: HER2-negative | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | Stratum II: HER2-positive | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | Stratum III: ER-positive, HER2-negative | Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies | 0 | 1 | 0 | 1 | 0 | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jesus Anampa Mesias | Albert Einstein College of Medicine | 718-405-8505 | janampa@montefiore.org |
| Nov 6, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2023 | Nov 7, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D000068878 | Trastuzumab |
| C000598430 | PF-05280014 |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| C056516 | exemestane |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| OG002 | Stratum C: HER2-negative | Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| OG003 | Stratum I: HER2-negative | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| OG004 | Stratum II: HER2-positive | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
| OG005 | Stratum III: ER-positive, HER2-negative | Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. Cytology Specimen Collection Procedure: Correlative studies Laboratory Biomarker Analysis: Correlative studies |
|