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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Genentech, Inc.
Sponsor:
Collaborator:
SOLTI Breast Cancer Research Group
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02301988
First received: November 24, 2014
Last updated: June 6, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Ipatasertib Drug: Paclitaxel Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-Blind, Study of Ipatasertib (GDC-0068), an Inhibitor to AKT, in Combination With Paclitaxel as Neoadjuvant Treatment for Patients With Early Stage Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • 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) [ Time Frame: 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) [ Time Frame: Surgery visit (at approximately Weeks 14 to 19) ]

Secondary Outcome Measures:
  • Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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+]) [ Time Frame: 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 Are Akt Dx+) [ Time Frame: Surgery visit (at approximately Weeks 14 to 19) ]
  • Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype [ Time Frame: Surgery visit (at approximately Weeks 14 to 19) ]
  • Percentage of Participants Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors [ Time Frame: Surgery visit (at approximately Weeks 14 to 19) ]
  • Percentage of Participants With Conversion to BCS Among Participants With T2 or T3 Tumors [ Time Frame: From screening to surgery visit (at approximately Weeks 14 to 19) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Screening up to Week 24 ]
  • Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24, Exposure After First Dose) of Ipatasertib [ Time Frame: 0.5 to 2 hours and 4 to 6 hours post dose on Day 1 of Cycle 1 (Cycle length = 28 days) ]
    AUC0-24 will be calculated by extrapolation.

  • Area Under the Concentration-Time Curve at Steady State (AUCss) of Ipatasertib [ Time Frame: 0.5 to 2 hours and 4 to 6 hours post dose on Day 1 of Cycle 1, 0 to 2 hours before dose and 2 to 5 hours post dose on Cycle 1 Day 8 (Cycle length = 28 days) ]
  • Minimum Observed Plasma Concentration (Cmin) of Ipatasertib [ Time Frame: 0.5 to 2 hours and 4 to 6 hours post dose on Day 1 of Cycle 1, 0 to 2 hours before dose and 2 to 5 hours post dose on Cycle 1 Day 8 (Cycle length = 28 days) ]
  • Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib [ Time Frame: 0.5 to 2 hours and 4 to 6 hours post dose on Day 1 of Cycle 1, 0 to 2 hours before dose and 2 to 5 hours post dose on Cycle 1 Day 8 (Cycle length = 28 days) ]

Estimated Enrollment: 150
Actual Study Start Date: February 17, 2015
Estimated Study Completion Date: September 1, 2017
Estimated Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: 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.
Other Name: GDC-0068
Drug: 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 Comparator: 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).
Drug: Paclitaxel
Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion QW for 3 cycles.
Drug: Placebo
Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02301988

Contacts
Contact: Reference Study ID Number: GO29505 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 44 Study Locations
Sponsors and Collaborators
Genentech, Inc.
SOLTI Breast Cancer Research Group
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02301988     History of Changes
Other Study ID Numbers: GO29505
2014-003029-16 ( EudraCT Number )
Study First Received: November 24, 2014
Last Updated: June 6, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017