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History of Changes for Study: NCT02301988
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Patients With Early Stage Triple Negative Breast Cancer
Latest version (submitted September 20, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 24, 2014 None (earliest Version on record)
2 December 3, 2014 Study Status and Sponsor/Collaborators
3 December 12, 2014 Recruitment Status, Study Status and Contacts/Locations
4 December 22, 2014 Contacts/Locations and Study Status
5 January 6, 2015 Study Status
6 February 4, 2015 Study Status, Study Description and Oversight
7 February 17, 2015 Contacts/Locations and Study Status
8 February 26, 2015 Study Status and Contacts/Locations
9 March 3, 2015 Study Status
10 March 19, 2015 Contacts/Locations and Study Status
11 April 1, 2015 Contacts/Locations and Study Status
12 April 7, 2015 Study Status
13 May 5, 2015 Study Status and Contacts/Locations
14 May 28, 2015 Contacts/Locations and Study Status
15 July 1, 2015 Study Status and Contacts/Locations
16 July 31, 2015 Contacts/Locations and Study Status
17 August 17, 2015 Study Status and Contacts/Locations
18 September 1, 2015 Contacts/Locations and Study Status
19 September 9, 2015 Contacts/Locations and Study Status
20 October 1, 2015 Study Status and Contacts/Locations
21 November 2, 2015 Contacts/Locations and Study Status
22 December 1, 2015 Study Status and Contacts/Locations
23 December 31, 2015 Contacts/Locations and Study Status
24 February 1, 2016 Study Status and Contacts/Locations
25 March 1, 2016 Contacts/Locations and Study Status
26 April 2, 2016 Contacts/Locations and Study Status
27 May 4, 2016 Contacts/Locations and Study Status
28 June 1, 2016 Contacts/Locations and Study Status
29 July 1, 2016 Study Status and Contacts/Locations
30 August 1, 2016 Study Status and Contacts/Locations
31 September 1, 2016 Study Status and Contacts/Locations
32 October 3, 2016 Study Status and Contacts/Locations
33 November 1, 2016 Study Status and Contacts/Locations
34 April 24, 2017 Study Status, Outcome Measures, Contacts/Locations, Arms and Interventions, Study Identification, Eligibility and Study Description
35 June 6, 2017 Study Status, Contacts/Locations and Eligibility
36 July 11, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
37 November 10, 2017 Recruitment Status, Study Status and Contacts/Locations
38 January 22, 2018 Study Status
39 February 12, 2018 Contacts/Locations and Study Status
40 March 19, 2018 Study Status
41 May 3, 2018 Study Status
42 June 21, 2018 Study Status
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Results Submission Events
43 August 22, 2018 Outcome Measures, Study Status, Document Section and Results
44 September 20, 2018 Study Status and Outcome Measures
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Study NCT02301988
Submitted Date:  November 24, 2014 (v1)
Open or close this module Study Identification
Unique Protocol ID: GO29505
Brief Title: A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Patients With Early Stage Triple Negative Breast Cancer
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
Secondary IDs: 2014-003029-16 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2014
Overall Status: Not yet recruiting
Study Start: December 2014
Primary Completion: March 2017 [Anticipated]
Study Completion: March 2017 [Anticipated]
First Submitted: November 24, 2014
First Submitted that
Met QC Criteria:		 November 24, 2014
First Posted: November 26, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		 November 24, 2014
Last Update Posted: November 26, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Genentech, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter, pre-operati ve 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 anticipat ed time on study treatment is 12 weeks. The target sample size is 130.
Detailed Description:
Open or close this module Conditions
Conditions: Breast Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Pathological complete response (pCR) rate in breast and axilla
[ Time Frame: Following completion of neoadjuvant therapy and surgery, approximately 17 weeks ]
Secondary Outcome Measures:
1. 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 ]
2. 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 ]
3. Efficacy (composite outcome measure): rates of BCS and conversion to BCS in patients with T2 or T3 tumors
[ Time Frame: Approximately week 17 ]
4. 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 ]
5. 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 ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GO29505 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. Only)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Genentech, Inc.
Locations: United States, California
Santa Barbara, California, United States, 93105
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Nebraska
Omaha, Nebraska, United States, 68130
United States, North Carolina
Charlotte, North Carolina, United States, 28208
United States, Oregon
Portland, Oregon, United States, 97213
United States, Texas
Austin, Texas, United States, 78705
Austin, Texas, United States, 78731
McAllen, Texas, United States, 78503
Portugal
Lisboa, Portugal, 1099-023
Loures, Portugal, 2674-514
Porto, Portugal, 4200-072
Spain
Barcelona, Spain, 08028
Barcelona, Spain, 08035
Barcelona, Spain, 08907
Caceres, Spain, 10003
Castellon, Spain, 12002
Girona, Spain, 17007
Madrid, Spain, 28033
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28050
Madrid, Spain, 28223
Sevilla, Spain, 41013
Valencia, Spain, 46010
Spain, Alicante
Torrevieja, Alicante, Spain, 03186
Spain, Islas Baleares
Palma De Mallorca, Islas Baleares, Spain, 07014
Palma de Mallorca, Islas Baleares, Spain, 07198
Spain, La Coruña
Santiago de Compostela, La Coruña, Spain, 15706
Spain, Lerida
Lleida, Lerida, Spain, 25198
Spain, Sevilla
Seville, Sevilla, Spain, 41071
Spain, Tarragona
Reus, Tarragona, Spain, 43204
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services