New drug cocktail targets Hard-to-Treat breast cancer

NCT ID NCT07405801

Recruiting now Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This phase 2 trial is testing whether adding a drug called inavolisib to two standard treatments (ribociclib and fulvestrant) can shrink tumors or slow cancer growth in people with advanced hormone-receptor-positive, HER2-negative breast cancer that has a specific genetic change (loss of chromosome 8p) but no PIK3CA mutation. About 80 participants will be randomly assigned to receive either the three-drug combo or a placebo plus the two standard drugs. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: inavolisib, ribociclib, and fulvestrant
What this could lead to: If successful, this could offer a new targeted treatment option for people with a specific type of advanced breast cancer that has stopped responding to hormone therapy.
What could go wrong: This is an early phase 2 trial with only 80 participants, so results may not apply to everyone. The combination may cause side effects or fail to improve outcomes compared to standard care.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER

Contacts and locations

Locations

AMG Oncology and Hematology Avera Cancer Institute - Yankton
RECRUITING

Yankton, South Dakota, 57078, United States
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
RECRUITING

Guadalajara, 44280, Mexico
Asst Papa Giovanni XXIII
RECRUITING

Bergamo, Lombardy, 24127, Italy
Avera Cancer Institute
RECRUITING

Sioux Falls, South Dakota, 57105, United States
Avera Cancer Institute - Aberdeen
RECRUITING

Aberdeen, South Dakota, 57401, United States
Avera Cancer Institute - Marshall
RECRUITING

Marshall, Minnesota, 56258, United States
Avera Cancer Institute - Mitchell
RECRUITING

Mitchell, South Dakota, 57301, United States
Avera Cancer Institute - Pierre, SD
RECRUITING

Pierre, South Dakota, 57501, United States
Bialostockie Centrum Onkologii
RECRUITING

Bialystok, 15-027, Poland
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
RECRUITING

Chicoutimi, Quebec, G7H 5H6, Canada
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
RECRUITING

Lublin, 20-090, Poland
Centre Leon Berard
RECRUITING

Lyon, 69008, France
Centre Oscar Lambret
RECRUITING

Lille, 59020, France
Centro Médico Fleischer
RECRUITING

Capital Federal, C1414, Argentina
Centro Oncologico Korben
RECRUITING

Caba, C1426AGE, Argentina
Centro de Investigacion Clinica de Oaxaca
RECRUITING

Oaxaca City, Oaxaca, 68020, Mexico
Christie Hospital Nhs Trust
RECRUITING

Manchester, M20 4GJ, United Kingdom
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
RECRUITING

São Paulo, São Paulo, 01317-000, Brazil
Dolno?l?skie Centrum Onkologii
RECRUITING

Wroc?aw, 53-413, Poland
Gachon University Gil Medical Center
RECRUITING

Namdong-Gu, 21565, South Korea
Hospital Brasilia
RECRUITING

Brasília, Federal District, 71.635-610, Brazil
Hospital Clinic Barcelona
RECRUITING

Barcelona, 08036, Spain
Hospital Clinico Universitario de Valencia
RECRUITING

Valencia, 46010, Spain
Hospital Ramon y Cajal
RECRUITING

Madrid, 28034, Spain
Hospital Santa Rita de Cassia Vitoria
RECRUITING

Vitória, Espírito Santo, 29043-260, Brazil
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Clínico San Cecilio
RECRUITING

Granada, 18016, Spain
ICO L'Hospitalet
RECRUITING

L'Hospitalet de Llobregat, Barcelona, 08908, Spain
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
RECRUITING

Meldola, Emilia-Romagna, 47014, Italy
Ictrials Pesquisa e Desenvolvimento
RECRUITING

Curitiba, Paraná, 80510-130, Brazil
Inst. Alexander Fleming
RECRUITING

Buenos Aires, C1426ANZ, Argentina
Institut Paoli Calmettes
RECRUITING

Marseille, 13273, France
Institut Régional du Cancer de Montpellier
RECRUITING

Montpellier, 34298, France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
RECRUITING

Toulouse, 31059, France
Instituto Nacional De Cancerologia
RECRUITING

Distrito Federal, Mexico CITY (federal District), 14000, Mexico
Instytut "Centrum Zdrowia Matki Polki"
RECRUITING

?ód?, 93-338, Poland
Irccs Istituto Nazionale Dei Tumori (Int)
RECRUITING

Milan, Lombardy, 20133, Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
RECRUITING

Naples, Campania, 80131, Italy
Leicester Royal Infirmary
RECRUITING

Leicester, LE1 5WWi, United Kingdom
Los Angeles Cancer Network - Anaheim
RECRUITING

Anaheim, California, 92805, United States
McGill University
RECRUITING

Montreal, Quebec, H4A 3J1, Canada
Nationales Centrum für Tumorerkrankungen (NCT)
RECRUITING

Heidelberg, 69120, Germany
Ospedale San Raffaele
RECRUITING

Milan, Lombardy, 20132, Italy
Ottawa General Hospital
RECRUITING

Ottawa, Ontario, K1H 8L6, Canada
Royal Free Hospital
RECRUITING

London, NW3 2QG, United Kingdom
Sanatorio de la Mujer
RECRUITING

Rosario, S2000ORE, Argentina
Seoul National University Bundang Hospital
RECRUITING

Seongnam-si, 13605, South Korea
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Soon Chun Hyang University Cheonan Hospital
RECRUITING

Dongnam-gu, Cheonan-si, 31151, South Korea
Stanford Cancer Institute
RECRUITING

Palo Alto, California, 94304, United States
Sunnybrook Health Science Centre
RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin
RECRUITING

Aachen, 52074, Germany
Università Campus Bio-Medico di Roma
RECRUITING

Rome, Lazio, 128, Italy
Universitätsklinik Tübingen
RECRUITING

Tübingen, 72076, Germany

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