A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
NCT ID: NCT02301988
Last Updated: 2018-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2015-02-17
2017-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ipatasertib + Paclitaxel
Participants will receive ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).
Ipatasertib
Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
Paclitaxel
Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m\^2) as IV infusion QW for 3 cycles.
Placebo + Paclitaxel
Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).
Paclitaxel
Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m\^2) as IV infusion QW for 3 cycles.
Placebo
Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
Interventions
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Ipatasertib
Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
Paclitaxel
Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m\^2) as IV infusion QW for 3 cycles.
Placebo
Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma of the breast with primary tumor greter than or equal to (\>/=) 1.5 centimeters (cm) in largest diameter (cT1-3) by MRI
* Adequate hematologic and organ function within 14 days before the first study treatment
* Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy of breast primary tumor
* For female participants of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment
Exclusion Criteria
* Any prior treatment for the current primary invasive breast cancer
* Participants with cT4 or cN3 stage breast tumors
* Metastatic (Stage IV) breast cancer
* Bilateral invasive breast cancer
* Multicentric breast cancer
* Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
18 Years
FEMALE
No
Sponsors
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SOLTI Breast Cancer Research Group
OTHER
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Arizona Oncology Associates, PC-CASA
Tucson, Arizona, United States
Sansum Medical Clinic, Inc.
Santa Barbara, California, United States
Rocky Mountain Cancer Center - Lakewood (West)
Lakewood, Colorado, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mass General/North Shore Cancer
Danvers, Massachusetts, United States
Nebraska Cancer Specialists; Oncology Hematology West, PC
Omaha, Nebraska, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Northwest Cancer Specialists - Portland (NE Hoyt St)
Portland, Oregon, United States
Roper Bon Secours St. Francis Cancer Center
Charleston, South Carolina, United States
Texas Oncology
Austin, Texas, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Houston (Gessner)
Houston, Texas, United States
Texas Oncology-Tyler
Irving, Texas, United States
South Texas Cancer Center - McAllen
McAllen, Texas, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
IPO de Lisboa; Servico de Oncologia Medica
Lisbon, , Portugal
Hospital Beatriz Angelo; Departamento de Oncologia
Loures, , Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, , Portugal
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, Spain
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Castellon, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain
Hospital Universitari de Lleida Arnau de Vilanova
Lleida, Lerida, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón (Madrid), Madrid, Spain
Hospital Rey Juan Carlos; Pharmacy
Móstoles, Madrid, Spain
Hospital Regional Universitario Carlos Haya; hospital Materno Infantil, servicio de Farmacia
Málaga, Malaga, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus, Tarragona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Cáceres, , Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
Girona, , Spain
Centro Oncologico MD Anderson International Espana
Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, , Spain
Hospital Quiron de Madrid; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario de Fuenlabrada; Servicio de Oncologia
Madrid, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario; Oncologia
Valencia, , Spain
Countries
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References
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Oliveira M, Saura C, Nuciforo P, Calvo I, Andersen J, Passos-Coelho JL, Gil Gil M, Bermejo B, Patt DA, Ciruelos E, de la Pena L, Xu N, Wongchenko M, Shi Z, Singel SM, Isakoff SJ. FAIRLANE, a double-blind placebo-controlled randomized phase II trial of neoadjuvant ipatasertib plus paclitaxel for early triple-negative breast cancer. Ann Oncol. 2019 Aug 1;30(8):1289-1297. doi: 10.1093/annonc/mdz177.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-003029-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29505
Identifier Type: -
Identifier Source: org_study_id
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