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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 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: August 1, 2016
Last verified: August 2016
  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. The target sample size is 130.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • Pathological complete response (pCR) rate in breast and axilla [ Time Frame: Following completion of neoadjuvant therapy and surgery, approximately 17 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response by MRI, as assessed by the investigator per modified Response Evaluation Criteria in Solid Tumors [ Time Frame: Response by MRI will be assessed after 3 cycles (12 weeks) and at any time progression is suspected ] [ Designated as safety issue: No ]
  • pCR rate in breast, as defined by ypT0/Tis in the American Joint Committee on Cancer staging system by local pathology evaluation [ Time Frame: Approximately week 17 ] [ Designated as safety issue: No ]
  • Efficacy (composite outcome measure): rates of BCS and conversion to BCS in patients with T2 or T3 tumors [ Time Frame: Approximately week 17 ] [ Designated as safety issue: No ]
  • Safety (composite outcome measure): Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.0 [ Time Frame: From baseline to 30 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics (composite outcome measure): PK parameters of ipatasertib plasma concentration over time (exposure following first dose [AUC0-24] and steady state (AUCss), trough concentration [Cmin], apparent clearance [CL/F]) [ Time Frame: Day 1 and 8 sampling in Cycle 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Paclitaxel + Ipatasertib Drug: Ipatasertib
400 mg daily oral administration on Days 1-21, every 28 days for 3 cycles
Other Name: GDC-0068
Drug: Paclitaxel
80 mg/m2 intravenous infusion on Days 1, 8, 15, and 22 of each 4-week cycle, for a total of 3 cycles of treatment
Placebo Comparator: Arm 2: Paclitaxel + Placebo Drug: Paclitaxel
80 mg/m2 intravenous infusion on Days 1, 8, 15, and 22 of each 4-week cycle, for a total of 3 cycles of treatment
Drug: Placebo
Matching placebo to ipatasertib, oral administration daily on Days 1-21, every 28 days for 3 cycles

  Eligibility

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

Inclusion Criteria:

  • Premenopausal or postmenopausal women, age >/=18 years
  • 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 >/=1.5 cm in largest diameter (cT1-3) by magnetic resonance imaging (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 patients 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 HER2-positive, ER-positive, or PgR-positive breast cancer
  • Any prior treatment for the current primary invasive breast cancer
  • Patients 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 patient 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.rochegenentechtrials@roche.com

  Show 38 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 
Study First Received: November 24, 2014
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration

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 August 30, 2016