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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003058-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Breast International Group | OTHER |
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Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting.
The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy.
The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: nab-Paclitaxel 150 mg/m2 days 1,15 | Experimental | Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
| B: nab-Paclitaxel 100 mg/m2 days 1,8,15 | Experimental | Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
| C: nab-Paclitaxel 75 mg/m2 days 1,8,15,22 | Experimental | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-Paclitaxel | Drug | Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Time from randomization until objective disease progression [progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions] or death, whichever occurs first. For patients without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (12 weeks) following the date last known progression-free, in which case the death was counted as a PFS event. | Reported after 18.2 months median follow-up since randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Treatment: Number of Participants Completed Treatment According to the Protocol for at Least 24 Weeks | Whether or not the patient completed treatment according to the protocol for at least 24 weeks. Patients who progressed within 24 weeks were considered as not completing. | Baseline to 24 weeks follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Gennari, MD | Division of Medical Oncology, E.O. Galliera, Genoa, Italy | Study Chair |
| Guy Jerusalem, MD, PhD | CHU Sart Tilman and University of Liège, Liège, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR de la Citadelle, Oncology-Haematology Unit | Liège | 4000 | Belgium | |||
| CHU Sart Tilman, Medical Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17647245 | Background | Chia SK, Speers CH, D'yachkova Y, Kang A, Malfair-Taylor S, Barnett J, Coldman A, Gelmon KA, O'reilly SE, Olivotto IA. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer. 2007 Sep 1;110(5):973-9. doi: 10.1002/cncr.22867. | |
| 16149088 | Background |
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255 patients were randomized between 16April2013 and 7August2015 at 35 centers in 5 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Nab-Paclitaxel 150 mg/m2 Days 1,15 | Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2015 | Aug 23, 2018 |
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|
| Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks |
Overall response of stable disease (or non-CR/non-PD for patients with non-measurable disease) for a duration of ≥24 weeks, or better (i.e., partial or complete response) according to RECIST criteria [Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.] |
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months |
| Best Overall Response | Best response according to RECIST 1.1 criteria [assessed by MRI] recorded from the start of treatment across all time points until end of study treatment. Confirmation of partial or complete response by an additional scan was not requested in this trial. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months |
| Overall Survival | Time from randomization until death from any cause, or censored at date last known alive | Reported after 18.2 months median follow-up since randomization |
| Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6) | Primary quality of life=physical well being; endpoint based on the GLQ 8. The indicator was in Linear Analogue Self-Assessment (LASA) format ranging 0-100 (0=as bad as it can be, 100=as good as it can be). | Assessed from day 1 of cycle 4 through day 1 of cycle 12 |
| Liège |
| 4000 |
| Belgium |
| Centre Hospitalier Peltzer-La Tourelle, Department of Clinical Cancerology | Verviers | 4800 | Belgium |
| Bon Secours | Cork | Ireland |
| Cork University Hospital | Cork | Ireland |
| Beaumont Hospital | Dublin | Ireland |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| Mater Private Hospital | Dublin | Ireland |
| St James's Hospital | Dublin | Ireland |
| St Vincent's University Hospital | Dublin | Ireland |
| University Hospital Galway | Galway | Ireland |
| Mid-Western Regional Hospital | Limerick | Ireland |
| Waterford Regional Hospital | Waterford | Ireland |
| Azienda Ospedaliera SS Antonio e Biagio | Alessandria | 15121 | Italy |
| Ospedale degli Infermi | Biella | 13900 | Italy |
| IRCCS MultiMedica | Castellanza | 21053 | Italy |
| E.O. Ospedali Galliera | Genova | 16128 | Italy |
| Istituto Europeo di Oncologia (IEO) | Milan | Italy |
| Uo Medicina Ocologica Ospedale Di Carpri e Mirandola, Azienda USL di Modena | Modena | 41012 | Italy |
| Fondazione Salvatore Maugeri | Pavia | 27100 | Italy |
| U.O. Oncologia, AUSL Rimini | Rimini | 47923 | Italy |
| Universita degli Studi di Roma La Sapienza | Roma | 00161 | Italy |
| Azienda Osp. Universitaria di Udine | Udine | 33100 | Italy |
| Ospedale di Circolo e Fondatione Macchi | Varese | 21100 | Italy |
| Institute of Oncology | Ljubljana | 1000 | Slovenia |
| Hospital Universitari Vall D'Hebron | Barcelona | Spain |
| Consorcop Hospitalario Provincial De Castellon | Castelló | 12002 | Spain |
| Hospital Universitari Arnau De Vilanova De Lleida | Lleida | 25198 | Spain |
| Hospital Universitari Sant Joan De Reus | Tarragona | 43204 | Spain |
| Hospital Universitario Lozano Blesa De Zaragoza | Zaragoza | 50009 | Spain |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| Universitätsspital Basel | Basel | 4031 | Switzerland |
| Instituto Oncologico della Svizzera Italiana | Bellinzona | 6500 | Switzerland |
| Universitätsspital/ Inselspital Bern | Bern | 3011 | Switzerland |
| Spitalzentrum Biel | Biel | 2501 | Switzerland |
| Kantonsspital Graubünden | Chur | 7000 | Switzerland |
| Kantonsspital Baselland | Liestal | 4410 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6000 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Onkologiezentrum Thun-Berner Oberland | Thun | 3600 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
| Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50. doi: 10.1002/cncr.21359. |
| 15310773 | Background | Andre F, Slimane K, Bachelot T, Dunant A, Namer M, Barrelier A, Kabbaj O, Spano JP, Marsiglia H, Rouzier R, Delaloge S, Spielmann M. Breast cancer with synchronous metastases: trends in survival during a 14-year period. J Clin Oncol. 2004 Aug 15;22(16):3302-8. doi: 10.1200/JCO.2004.08.095. |
| 18725649 | Background | Dawood S, Broglio K, Gonzalez-Angulo AM, Buzdar AU, Hortobagyi GN, Giordano SH. Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol. 2008 Oct 20;26(30):4891-8. doi: 10.1200/JCO.2007.14.1168. Epub 2008 Aug 25. |
| 29228091 | Derived | Gennari A, Sun Z, Hasler-Strub U, Colleoni M, Kennedy MJ, Von Moos R, Cortes J, Vidal MJ, Hennessy B, Walshe J, Parraga KA, Ribi K, Bernhard J, Murillo SM, Pagani O, Barbeaux A, Borstnar S, Rabaglio-Poretti M, Maibach R, Regan MM, Jerusalem G; International Breast Cancer Study Group, Cancer Trials Ireland and SOLTI Group. A randomized phase II study evaluating different maintenance schedules of nab-paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial. Ann Oncol. 2018 Mar 1;29(3):661-668. doi: 10.1093/annonc/mdx772. |
| FG001 | B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 | Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
| FG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-treat population. Arm A had randomized 86 patient, but only 83 were analyzed. 3 patients excluded from analysis, who immediately withdrew consent or cancelled treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A: Nab-Paclitaxel 150 mg/m2 Days 1,15 | Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) |
| BG001 | B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 | Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) |
| BG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) |
| BG003 | 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, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| ER Status | Count of Participants | Participants |
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| Prior Taxanes | Count of Participants | Participants |
| ||||||||||||||||
| Type of Radiologically Evaluable Disease | Count of Participants | 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 | Progression-free Survival | Time from randomization until objective disease progression [progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions] or death, whichever occurs first. For patients without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (12 weeks) following the date last known progression-free, in which case the death was counted as a PFS event. | Intention-to-treat population | Posted | Median | 90% Confidence Interval | months | Reported after 18.2 months median follow-up since randomization |
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| Secondary | Feasibility of Treatment: Number of Participants Completed Treatment According to the Protocol for at Least 24 Weeks | Whether or not the patient completed treatment according to the protocol for at least 24 weeks. Patients who progressed within 24 weeks were considered as not completing. | Intention to treat population | Posted | Count of Participants | Participants | Baseline to 24 weeks follow-up |
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| Secondary | Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks | Overall response of stable disease (or non-CR/non-PD for patients with non-measurable disease) for a duration of ≥24 weeks, or better (i.e., partial or complete response) according to RECIST criteria [Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.] | Intention to treat population | Posted | Count of Participants | Participants | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months |
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| Secondary | Best Overall Response | Best response according to RECIST 1.1 criteria [assessed by MRI] recorded from the start of treatment across all time points until end of study treatment. Confirmation of partial or complete response by an additional scan was not requested in this trial. | Intention to treat population | Posted | Count of Participants | Participants | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months |
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| Secondary | Overall Survival | Time from randomization until death from any cause, or censored at date last known alive | Intention to treat population | Posted | Median | 90% Confidence Interval | months | Reported after 18.2 months median follow-up since randomization |
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| Secondary | Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6) | Primary quality of life=physical well being; endpoint based on the GLQ 8. The indicator was in Linear Analogue Self-Assessment (LASA) format ranging 0-100 (0=as bad as it can be, 100=as good as it can be). | Patients who started the maintenance phase of treatment (cycle 4) | Posted | Mean | 95% Confidence Interval | units on a scale | Assessed from day 1 of cycle 4 through day 1 of cycle 12 |
|
Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Nab-Paclitaxel 150 mg/m2 Days 1,15 | Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². | 51 | 83 | 78 | 83 | ||
| EG001 | B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 | Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². | 43 | 86 | 83 | 86 | ||
| EG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². | 57 | 86 | 80 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Ileal obstruction | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE v4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| GGT increased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Musculoskeletal and connective - Other | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Spasticity | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Reproductive system and breast | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Respiratory thoracic mediastinal - Other,10038738 | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Periorbital edema | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Recurrent Laryngeal nerve Palsy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Heart Failure | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi Roschitzki-Voser | International Breast Cancer Study Group (IBCSG) | +41 31 511 94 18 | heidi.roschitzki@ibcsg.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2016 | Aug 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Ireland |
|
| Italy |
|
| Slovenia |
|
| Switzerland |
|
| Spain |
|
| Negative |
|
| No |
|
| Non-measurable only |
|
For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months. |
| Log Rank |
One-sided test |
| .03 |
Not adjusted for multiple comparisons; One-sided .05 alpha-level test |
| Superiority |
| For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months. | Log Rank | One-sided test | .20 | Not adjusted for multiple comparisons; One-sided .05 alpha-level test | Superiority |
| OG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
|
Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
| OG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
|
| OG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
|
| OG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
|
| OG002 | C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 | Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². |
|
|