A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer

NCT02301988 | Completed Phase 2 Results

• 2 other identifiers: GO295052014-003029-16
• Study Type: interventional
• Target: 151
• Locations: 3 countries
• Sites: 42

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants)

  pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.

  Surgery visit (at approximately Weeks 14 to 19)

• Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors)

  pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.

  Surgery visit (at approximately Weeks 14 to 19)

Secondary Outcomes (12)

• Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants)

  Surgery visit (at approximately Weeks 14 to 19)

• Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors)

  Surgery visit (at approximately Weeks 14 to 19)

• Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants)

  Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16])

• Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors)

  Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16])

• Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Diagnostic Positive [Dx+])

  Surgery visit (at approximately Weeks 14 to 19)

Study Arms (2)

Ipatasertib + Paclitaxel

EXPERIMENTAL

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).

Drug: Ipatasertib; Drug: Paclitaxel

Placebo + Paclitaxel

PLACEBO COMPARATOR

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).

Drug: Paclitaxel; Drug: Placebo

Interventions

Ipatasertib DRUG

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.

Also known as: GDC-0068

Ipatasertib + Paclitaxel

Paclitaxel DRUG

Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m\^2) as IV infusion QW for 3 cycles.

Ipatasertib + Paclitaxel; Placebo + Paclitaxel

Placebo DRUG

Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.

Placebo + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal or postmenopausal women
• 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

You may not qualify if:

• Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor (ER)-positive, or progesterone receptor (PgR)-positive breast cancer
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead
• SOLTI Breast Cancer Research Group: collaborator

Study Sites (42)

Arizona Oncology Associates, PC-CASA

Tucson, Arizona, 85704, United States

Location

Sansum Medical Clinic, Inc.

Santa Barbara, California, 93105, United States

Location

Rocky Mountain Cancer Center - Lakewood (West)

Lakewood, Colorado, 80228, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mass General/North Shore Cancer

Danvers, Massachusetts, 01923, United States

Location

Nebraska Cancer Specialists; Oncology Hematology West, PC

Omaha, Nebraska, 68130, United States

Location

Carolinas Healthcare System

Charlotte, North Carolina, 28208, United States

Location

Northwest Cancer Specialists - Portland (NE Hoyt St)

Portland, Oregon, 97213, United States

Location

Roper Bon Secours St. Francis Cancer Center

Charleston, South Carolina, 29414, United States

Location

Texas Oncology

Austin, Texas, 78705, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Houston (Gessner)

Houston, Texas, 77024, United States

Location

Texas Oncology-Tyler

Irving, Texas, 75063, United States

Location

South Texas Cancer Center - McAllen

McAllen, Texas, 78503, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

IPO de Lisboa; Servico de Oncologia Medica

Lisbon, 1099-023, Portugal

Location

Hospital Beatriz Angelo; Departamento de Oncologia

Loures, 2674-514, Portugal

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Son Llatzer; Servicio de Oncologia

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital Provincial de Castellon; Servicio de Oncologia

Castellon, Castellon, 12002, Spain

Location

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Hospital Universitari de Lleida Arnau de Vilanova

Lleida, Lerida, 25198, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón (Madrid), Madrid, 28922, Spain

Location

Hospital Rey Juan Carlos; Pharmacy

Móstoles, Madrid, 28933, Spain

Location

Hospital Regional Universitario Carlos Haya; hospital Materno Infantil, servicio de Farmacia

Málaga, Malaga, 29011, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41071, Spain

Location

Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

Reus, Tarragona, 43204, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital San Pedro De Alcantara; Servicio de Oncologia

Cáceres, 10003, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

Girona, 17007, Spain

Location

Centro Oncologico MD Anderson International Espana

Madrid, 28033, Spain

Location

Fundacion Jimenez Diaz; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

Madrid, 28050, Spain

Location

Hospital Quiron de Madrid; Servicio de Oncologia

Madrid, 28223, Spain

Location

Hospital Universitario de Fuenlabrada; Servicio de Oncologia

Madrid, 28943, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Universitario; Oncologia

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 31147675 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ipatasertib; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: February 17, 2015
• Primary Completion: August 2, 2017
• Study Completion: August 2, 2017
• Last Updated: October 17, 2018
• Results First Posted: September 20, 2018

Record last verified: 2018-09

Locations

US (16); PT (3); ES (23)