Breast Cancer Clinical Trial
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
Summary
The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.
Full Description
An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting, and who have received at least one, and no more than three, lines of therapy overall in the metastatic setting. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.
Eligibility Criteria
Inclusion Criteria:
Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
Life expectancy ≥ 12 weeks
Acceptable laboratory parameters
Women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug.
Infusion sub-study prior therapy requirements: Same as above, except:
Must have received 4 or more prior lines or therapy in the metastatic setting
Must have received prior trastuzumab, pertuzumab, and T-DM1
Exclusion Criteria:
Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
History of uncontrolled seizures within 6 months of randomization
History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
History of clinically significant cardiovascular disease
Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy
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There are 164 Locations for this study
Chandler Arizona, 85224, United States
Gilbert Arizona, 85234, United States
Goodyear Arizona, 85338, United States
Burbank California, 91505, United States
Los Angeles California, 90095, United States
Sacramento California, 95817, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Vallejo California, 94589, United States
Fort Collins Colorado, 80528, United States
Washington District of Columbia, 20010, United States
Fort Myers Florida, 33916, United States
Hollywood Florida, 33021, United States
Miami Beach Florida, 33140, United States
New Port Richey Florida, 34655, United States
Orlando Florida, 32806, United States
Port Saint Lucie Florida, 34952, United States
West Palm Beach Florida, 33401, United States
Atlanta Georgia, 30318, United States
Marietta Georgia, 30060, United States
Newnan Georgia, 30265, United States
Honolulu Hawaii, 96819, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Urbana Illinois, 61801, United States
Zion Illinois, 60099, United States
Goshen Indiana, 46526, United States
Hazard Kentucky, 41701, United States
Lexington Kentucky, 40504, United States
New Orleans Louisiana, 70115, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21202, United States
Boston Massachusetts, 02111, United States
Hattiesburg Mississippi, 39401, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63141, United States
Lebanon New Hampshire, 03756, United States
Brick New Jersey, 08724, United States
Hackensack New Jersey, 07601, United States
Livingston New Jersey, 07039, United States
Albuquerque New Mexico, 87106, United States
Jamaica New York, 11432, United States
Lake Success New York, 11042, United States
New York New York, 10016, United States
Winston-Salem North Carolina, 27157, United States
Oklahoma City Oklahoma, 73120, United States
Harrisburg Pennsylvania, 17109, United States
Monongahela Pennsylvania, 15063, United States
Philadelphia Pennsylvania, 19124, United States
Sayre Pennsylvania, 18840, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78758, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Salt Lake City Utah, 84106, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Fort Belvoir Virginia, 22060, United States
Seattle Washington, 98104, United States
Seattle Washington, 98109, United States
Spokane Washington, 99202, United States
Innsbruck Tirol, 6020, Austria
Edegem Antwerpen, 2650, Belgium
Wilrijk Antwerpen, 2610, Belgium
Ottignies Brabant Wallon, 1340, Belgium
Brussels Brussels Capital Region, 1090, Belgium
Brussels Brussels Capital Region, 1200, Belgium
Hasselt Limburg, 3500, Belgium
Sint-Niklaas Oost-Vlaanderen, 9100, Belgium
Brugge West-Vlaanderen, 8000, Belgium
Kortrijk West-Vlaanderen, 8500, Belgium
Oostende West-Vlaanderen, 8400, Belgium
Liège , 4000, Belgium
Namur , 5000, Belgium
Moncton New Brunswick, E1C 8, Canada
Oshawa Ontario, L1G 2, Canada
Brno Brno-město, 656 5, Czechia
Olomouc , 779 0, Czechia
Praha 5 , 150 0, Czechia
Aarhus C Central Jutland, 8000, Denmark
Herning Central Jutland, 7400, Denmark
Vejle South Denmark, 7100, Denmark
Aarhus N Zeeland, 4700, Denmark
Tampere Etelä-Suomen Lääni, 33521, Finland
Helsinki Länsi-Suomen Lääni, 00029, Finland
Nice Alpes-Martitimes, 06189, France
Caen cedex 05 Calvados, 14076, France
Dijon Côte-d'Or, 21079, France
St Herblain Loire-Atlantique, 44805, France
Clermont-Ferrand Puy-de-Dôme, 63011, France
Lyon Cedex 08 Rhône-Alpes, 69373, France
Paris ÃŽle-de-France, 75005, France
Saint-Cloud ÃŽle-de-France, 92210, France
Tuebingen Baden-Württemberg, 72076, Germany
Erlangen Bayern, 91054, Germany
München Bayern, 81925, Germany
Düsseldorf Nordhein-Westfalen, 40479, Germany
Essen Nordrhein-Westfalen, 45122, Germany
Witten Nordrhein-Westfalen, 58452, Germany
Dresden Sachsen, 01307, Germany
Heidelberg , , Germany
Beersheba HaDarom, 84802, Israel
Kfar Saba HaMerkaz, 44281, Israel
Petaẖ Tiqwa HaMerkaz, 49100, Israel
Ramat Gan HaMerkaz, 52621, Israel
Rehovot HaMerkaz, 76100, Israel
Jerusalem Yerushalayim, 91120, Israel
Haifa , 35152, Israel
Tel Aviv , 64239, Israel
Catania Cantania, 95122, Italy
Meldola Forli, 47014, Italy
Candiolo Torino, 10060, Italy
Siena Toscana, 53100, Italy
Ancona , 60126, Italy
Benevento , 82100, Italy
Bergamo , 24127, Italy
Cremona , 26100, Italy
Ferrara , 44124, Italy
Genova , 16128, Italy
Lecco , 23900, Italy
Milano , 20121, Italy
Milano , 20141, Italy
Modena , 41122, Italy
Napoli , 80131, Italy
Parma , 43126, Italy
Pavia , 27100, Italy
Pavia , 27100, Italy
Pisa , 56126, Italy
Prato , 59100, Italy
Roma , 00128, Italy
Roma , 00189, Italy
Viterbo , 01100, Italy
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Maastricht Limburg, 6229 , Netherlands
Haag Zuid-Holland, 2545 , Netherlands
Warszawa Mazowieckie, 04-12, Poland
Wieliszew Mazowieckie, 05-13, Poland
Lublin , 20-09, Poland
Lisbon Lisboa, 1400-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
San Juan , 927, Puerto Rico
Sevilla AndalucÃa, 41013, Spain
Badalona Barcelona, 08916, Spain
Sabadell Barcelona, 08208, Spain
Barcelona Catalunya, 08003, Spain
Valencia Comunidad, 46010, Spain
Pamplona Navarra, 31008, Spain
Reus Tarragona, 43204, Spain
Barcelona , 08023, Spain
Cáceres , 10003, Spain
Lleida , 25198, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Valencia , 46009, Spain
Valencia , 46026, Spain
Ãvila , 5004, Spain
London City Of London, SE1 9, United Kingdom
Hull East Riding Of Yorkshire, HU16 , United Kingdom
Maidstone Kent, ME16 , United Kingdom
Fulwood Lancashire, PR2 9, United Kingdom
Middlesbrough , TS4 3, United Kingdom
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