Promising targeted therapy for tough breast cancer hits roadblock
NCT ID NCT04251533
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 5 times
Summary
This study tested whether adding the drug alpelisib to standard chemotherapy (nab-paclitaxel) could help people with advanced triple negative breast cancer that has specific genetic changes (PIK3CA mutation or PTEN loss). The trial enrolled 137 participants but was stopped early. The goal was to see if the combination slowed cancer growth or shrank tumors. Because the study was terminated, final conclusions about effectiveness are limited.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hematology and Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
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Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
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Novartis Investigative Site
Rosario, Santa Fe Province, S2000KZE, Argentina
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Novartis Investigative Site
CABA, C1113AAE, Argentina
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Novartis Investigative Site
Melbourne, Victoria, 3000, Australia
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Novartis Investigative Site
Nedlands, Western Australia, 6009, Australia
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Novartis Investigative Site
Innsbruck, Tyrol, 6020, Austria
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Novartis Investigative Site
Leoben, A 8700, Austria
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Novartis Investigative Site
Barretos, São Paulo, 14784 400, Brazil
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Novartis Investigative Site
São Paulo, São Paulo, 01317-002, Brazil
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Novartis Investigative Site
São Paulo, São Paulo, 04014-002, Brazil
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Novartis Investigative Site
Plovdiv, 4004, Bulgaria
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Novartis Investigative Site
Hefei, Anhui, 230001, China
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Novartis Investigative Site
Shijiazhuang, Hebei, 050011, China
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Novartis Investigative Site
Changsha, Hunan, 410013, China
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Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
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Novartis Investigative Site
Nanchang, Jiangxi, 330009, China
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Novartis Investigative Site
Changchun, Jilin, 130021, China
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Novartis Investigative Site
Shengyang, Liaoning, 110042, China
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Novartis Investigative Site
Shenyang, Liaoning, 110011, China
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Novartis Investigative Site
Chengdu, Sichuan, 610041, China
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Novartis Investigative Site
Hangzhou, Zhejiang, 310016, China
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Novartis Investigative Site
Dalian, 116000, China
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Novartis Investigative Site
Shanghai, 200025, China
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Novartis Investigative Site
Tianjin, 300480, China
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Novartis Investigative Site
Bogotá, 110221, Colombia
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Novartis Investigative Site
Zagreb, 10000, Croatia
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Novartis Investigative Site
Saint-Cloud, Hauts De Seine, 92210, France
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Novartis Investigative Site
Angers, 49055, France
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Novartis Investigative Site
Saint-Herblain, 44805, France
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Novartis Investigative Site
Villejuif, 94800, France
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Novartis Investigative Site
Dresden, Saxony, 01307, Germany
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Novartis Investigative Site
Leipzig, Saxony, 04103, Germany
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Novartis Investigative Site
Essen, 45136, Germany
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Novartis Investigative Site
Budapest, 1134, Hungary
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Novartis Investigative Site
Faridabad, Haryana, 121 001, India
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Novartis Investigative Site
Mumbai, Maharashtra, 400056, India
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Novartis Investigative Site
Vellore, Tamil Nadu, 632 004, India
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Novartis Investigative Site
Hyderabad, Telangana, 500034, India
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Novartis Investigative Site
Tel Aviv, 6423906, Israel
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Novartis Investigative Site
Meldola, FC, 47014, Italy
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Novartis Investigative Site
Roma, RM, 00128, Italy
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Novartis Investigative Site
Naples, 80131, Italy
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Novartis Investigative Site
Petaling Jaya, Selangor, 46050, Malaysia
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Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
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Novartis Investigative Site
Monterrey, Nuevo León, 64460, Mexico
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Novartis Investigative Site
Oslo, NO-0407, Norway
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Novartis Investigative Site
Trujillo, La Libertad, 13011, Peru
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Novartis Investigative Site
Gdynia, 81 519, Poland
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Novartis Investigative Site
Opole, 45-061, Poland
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Novartis Investigative Site
Poznan, 61 485, Poland
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Novartis Investigative Site
Arkhangelsk, 163045, Russia
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Novartis Investigative Site
Chelyabinsk, 454048, Russia
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Novartis Investigative Site
Moscow, 117997, Russia
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Novartis Investigative Site
Moscow, 123056, Russia
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Novartis Investigative Site
Saint Petersburg, 196603, Russia
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Novartis Investigative Site
Bratislava, 812 50, Slovakia
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Novartis Investigative Site
Bratislava, 83310, Slovakia
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Novartis Investigative Site
Košice, 041 91, Slovakia
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Novartis Investigative Site
Ljubljana, 1000, Slovenia
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Novartis Investigative Site
Port Elizabeth, Western Cape, 6045, South Africa
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Novartis Investigative Site
Johannesburg, 2196, South Africa
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Novartis Investigative Site
Seoul, 03080, South Korea
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Novartis Investigative Site
Seoul, 05505, South Korea
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Novartis Investigative Site
Seoul, 06351, South Korea
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Novartis Investigative Site
Palma, Balearic Islands, 07120, Spain
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Novartis Investigative Site
Badajoz, Extremadura, 06080, Spain
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Novartis Investigative Site
Alicante, 03010, Spain
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Novartis Investigative Site
Lausanne, 1011, Switzerland
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Novartis Investigative Site
Taipei, 10002, Taiwan
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Novartis Investigative Site
Taipei, 10449, Taiwan
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Novartis Investigative Site
Istanbul, Fatih, 34098, Turkey (Türkiye)
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Novartis Investigative Site
Istanbul, Kadikoy, 34722, Turkey (Türkiye)
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Novartis Investigative Site
Nottingham, NG5 1PB, United Kingdom
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Novartis Investigative Site
Oxford, OX3 7LE, United Kingdom
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Park Nicollet Institute
Saint Louis Park, Minnesota, 55416, United States
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SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
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University of California LA
Los Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New hope for hard-to-treat cancers? experimental combo enters phase 2 trial
- Freezing tumors to supercharge immunotherapy: new hope for aggressive breast cancer?
- New antibody drug aims to unleash immune system on Hard-to-Treat cancers
- Immunotherapy avelumab aims to stop triple negative breast cancer recurrence
- New drug combo takes on advanced cancers in early trial
- New drug combo aims to keep advanced breast cancer in check