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| Name | Class |
|---|---|
| Yale University | OTHER |
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In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.
See above brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks |
|
| Cohort 2 | Experimental | Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7 Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abraxane | Drug | Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response Rates at Surgery | at surgery approximately 5 months after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Measure of safety and tolerability according to CTCAE version 3.0 | 2 years |
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Eligibility criteria
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Sikov, MD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States | ||
| Yale Smilow Cancer Center |
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DDAC: (dose-dense doxorubicin and cyclophosphamide (DDAC)
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) |
| FG001 | Cohort 2 | Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pathological Complete Response Rates at Surgery | Posted | Number | participants | at surgery approximately 5 months after initial treatment |
|
After run-in therapy neo-adjuvantly, throughout treatment and until completion of follow-up (5 years of follow-up) for a total of approximately 6.5 years
C1 neo: 33 patients enrolled to cohort 1 Neo-adjuvant, only 28 were evaluable C2 neo: 27 enrolled/evaluable cohort 2 Neo-adjuvant C1 DDAC: Of 28 patient evaluable neo-adjuvant, 27 treated DDAC C2 DDAC: Of 27 patients neo-adjuvant, 24 on DDAC C1 Avastin: Of 27 DDAC, 15 Avastin post-op C2 Avastin: Of 24 DDAC, 21 Avastin post-op
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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 | Cohort 1 Neo-adjuvant | Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gr 3 Nausea, gr 3 vomiting | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WBC | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Sikov, MD | BrUOG | 4018633000 | Roxanne_Wood@brown.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D013660 | Taxes |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Carboplatin | Drug | Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10 |
|
|
| Avastin | Drug | Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) |
|
|
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Rhode Island Hsopital | Providence | Rhode Island | 02903 | United States |
| Women and Infants | Providence | Rhode Island | 02905 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Adverse Event |
|
| BG001 | Cohort 2 | Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) |
|
|
| Secondary | Number of Participants With Adverse Events | Measure of safety and tolerability according to CTCAE version 3.0 | Pts with clinical stage IIA-IIIC BrCa | Posted | Number | participants | 2 years |
|
|
|
| 5 |
| 28 |
| 28 |
| 28 |
| EG001 | Cohort 2 Neo-adjuvant | Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) | 8 | 27 | 27 | 27 |
| EG002 | Cohort 1 DDAC | Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles | 10 | 27 | 27 | 27 |
| EG003 | Cohort 2 DDAC | Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles | 7 | 24 | 16 | 24 |
| EG004 | Cohort 1 Adjuvant Post Surgery | Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks | 2 | 15 | 5 | 15 |
| EG005 | Cohort 2 Adjuvant Post Surgery | Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks | 7 | 21 | 18 | 21 |
| gr 3 nausea, gr 2 infection with noraml ANC, gr 2 HGB, gr 1 glucose | Investigations | Systematic Assessment |
|
| gr 2 non-cardiac chest pain, gr 2 anemia | Investigations | Systematic Assessment |
|
| gr 3 infection (normal ANC) (cellulitis & pain in buttock - RT infection), gr 1 epistaxis | Investigations | Systematic Assessment |
|
| K gr 4,mental status gr 4, ventricular arrythmia gr 4, pneumonia gr 3 | Investigations | Systematic Assessment |
|
| gr 2 Pleural effusion | Investigations | Systematic Assessment |
|
| cr 2, dehydration2, anemia2, weight loss2, fatigue-1, dysgeusia-2, gastritis-2, anorexia-2 | Investigations | Systematic Assessment |
|
| Mucositis gr 3, fever gr 1, fatigue gr 1 | Investigations | Systematic Assessment |
|
| Acute Kidney Injury gr 2 | Investigations | Systematic Assessment |
|
| gr 4 GI Bleed (lesion in colon- villious adenoma) | Investigations | Systematic Assessment |
|
| FN-gr 1 fever, gr 3 ANC (gr 3 infection) | Investigations | Systematic Assessment |
|
| FN (fever gr1, ANC 3, infection3)- however during hospitalization ANC rose to grade 4 | Investigations | Systematic Assessment |
|
| gr 4 ANC, gr 2 bleeding hemorrhoid, gr 2 rectal pain, dizziness gr 2 | Investigations | Systematic Assessment |
|
| left groin abcess- gr 2 1/14/14**amended to grade 3** | Investigations | Systematic Assessment |
|
| dehydration gr 3, worsening anemia gr 3, diarrhea gr2, anorexia gr 2, ANC 3 | Investigations | Systematic Assessment |
|
| gr 3 FN (gr 3 infection, gr 3 ANC), gr 3 mucositis, gr 2 Diarrhea, Gr 2 pain rectal | Investigations | Systematic Assessment |
|
| gr 3 periorbital cellulitis associated with chalazia, gr 2 anemia | Investigations | Systematic Assessment |
|
| gr 4 ANC | Investigations | Systematic Assessment |
|
| anemia 2 | Investigations | Systematic Assessment |
|
| gr 2 dehydration, gr 2 wt loss, gr 2 anorexia, gr 3 esophagitis, gr 2 mucositis, gr 3 ANC, Gr 4 PLT | Investigations | Systematic Assessment |
|
| gr3 FN, gr3 HGB, Gr2 fatigue, gr2 nausea, gr2 anorexia, gr2 dehydration, gr1 fever, gr1 epistaxis | Investigations | Systematic Assessment | FN-(infection and ANC) |
|
| ANC 4, HGB 3, PLT 3 | Investigations | Systematic Assessment |
|
| weakness gr 4 | Investigations | Systematic Assessment |
|
| FN gr 3, ANC 3, anemia gr 2, thrombocytopenia gr 3 | Investigations | Systematic Assessment |
|
| FN gr3, bradycardia gr1, infection gr3, pancytopenia gr3, sore throat gr1, body aches gr1,rigors gr1 | Investigations | Systematic Assessment | with grade 4 HGB and PLT FN (fever gr 3 and ANC 4) |
|
| dehydration2, k3, nausea2, anemia2, cpain2, SOB1, FN, vomiting2, PLT 4, mucositis2, fatigue2 | Investigations | Systematic Assessment | FN - febrile neutropenia :(fever (3) and ANC(4)) |
|
| gr 2 odynophagia, gr 2 allergic rxn, gr 2 oral thrush, gr 4 ANC | Investigations | Systematic Assessment |
|
| Post Op and Pre-drug- gr 1 fever,gr 2 erythema, gr 2 chills | Investigations | Systematic Assessment |
|
| Post op- wound infection gr 2 on DIEP flap | Investigations | Systematic Assessment |
|
| FN gr 4 (fever gr 1, ANC 4), cough 2, nasal congestion 2 | Investigations | Systematic Assessment |
|
| FN (fever gr 1, ANC 4) Anemia 2 | Investigations | Systematic Assessment |
|
| bleeding from JP drain grade 1 | Investigations | Systematic Assessment |
|
| FN- fever gr 1, ANC 4 | Investigations | Systematic Assessment |
|
| FN gr 3 (fever gr 1, ANC gr 3) | Investigations | Systematic Assessment |
|
| Post surgery: gr 3 infection | Investigations | Systematic Assessment |
|
| gr 4 skin breakdown | Investigations | Systematic Assessment |
|
| gr 2 pleural effusion | Investigations | Systematic Assessment |
|
| grade 1 fever, gr 3 malignant pleural effusion | Investigations | Systematic Assessment |
|
| breast cellulitis gr 3, acute renal injury gr 2, diarrhea gr 1, hemmorrhage GI gr 3 | Investigations | Systematic Assessment |
|
| Post Reconstruction Surgery- infection left breast gr 3 | Investigations | Systematic Assessment |
|
| post radiation- gr 3 wound complication would dehiscence | Investigations | Systematic Assessment |
|
| gr 2 right arm weakness- motor neuropthay, right shoulder pain- r/o TIA | Investigations | Systematic Assessment |
|
| secondary malignancy: bladder cancer potentially related to DDAC | Investigations | Systematic Assessment |
|
| Left breast pain gr 2 | Investigations | Systematic Assessment |
|
| PE gr 4, fever gr 2 | Investigations | Systematic Assessment |
|
| post op comp breast cellulitis gr3, migraine gr2 | Investigations | Systematic Assessment | Plus:hypocalcemia gr2, hypokalemia gr1, hypomag gr1, anemia gr1, hypophos gr2 |
|
| related to reconstruction: infection with normal ANC- post complication healing issue (3) | Investigations | Systematic Assessment |
|
| ANC | Investigations | Systematic Assessment |
|
| PLT | Investigations | Systematic Assessment |
|
| HGB | Investigations | Systematic Assessment |
|
| Infection | Investigations | Systematic Assessment |
|
| Myalgias | Investigations | Systematic Assessment |
|
| Creatinine | Investigations | Systematic Assessment |
|
| Anorexia | Investigations | Systematic Assessment |
|
| Wt loss | Investigations | Systematic Assessment |
|
| Fatigue | Investigations | Systematic Assessment |
|
| Rash | Investigations | Systematic Assessment |
|
| Nausea | Investigations | Systematic Assessment |
|
| Vomiting | Investigations | Systematic Assessment |
|
| Mucositis | Investigations | Systematic Assessment |
|
| Rhinitis | Investigations | Systematic Assessment |
|
| Diarrhea | Investigations | Systematic Assessment |
|
| LFTs | Investigations | Systematic Assessment |
|
| Neurosensory | Investigations | Systematic Assessment |
|
| Neuromuscular | Investigations | Systematic Assessment |
|
| Hyponatremia | Investigations | Systematic Assessment |
|
| Hypokalemia | Investigations | Systematic Assessment |
|
| Hypomagnesmia | Investigations | Systematic Assessment |
|
| Hypocalcemia | Investigations | Systematic Assessment |
|
| Alk-Phos abnormality | Investigations | Systematic Assessment |
|
| Cough | Investigations | Systematic Assessment |
|
| epistaxis or bleeding | Investigations | Systematic Assessment |
|
| Chest Pain/Bradycardia | Investigations | Systematic Assessment |
|
| HTN | Investigations | Systematic Assessment |
|
| SOB | Investigations | Systematic Assessment |
|
| Proteinuria | Investigations | Systematic Assessment |
|
| Ocular | Investigations | Systematic Assessment |
|
| Hyperbili | Investigations | Systematic Assessment |
|
Not provided
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| D017437 |
| Skin and Connective Tissue Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |