A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02162719
• Date of registration: 11/06/2014
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
• Scientific title: A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer
• Date of first enrolment: August 19, 2014
• Target sample size: 124
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02162719
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Italy, Korea, Republic of, Singapore, Spain, Taiwan, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically documented triple-negative adenocarcinoma of the breast that is
inoperable locally advanced or metastatic and is not amenable to resection with
curative intent

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor
specimen, required prior to randomization

- Measurable disease, according to the RECIST v1.1

- Adequate hematologic and organ function within 14 days before the first study
treatment

- For female participants of childbearing potential, agreement (by both participant and
partner) to use an effective form of contraception for the duration of the study and
for 6 months after last dose of study treatment

Exclusion Criteria:

- Any previous therapy, including chemotherapy or hormonal or targeted therapy, for
inoperable locally advanced or metastatic triple-negative adenocarcinoma of the
breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy
and/or radiation treatment for locally advanced triple negative adenocarcinoma,
provided all treatments were completed greater than or equal to (>/=) 6 months prior
to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with
curative intent

- Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1

- Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor
(ER) positive, or progesterone receptor (PR) positive breast cancer

- Previous therapy with Akt, PI3K, and/or mTOR inhibitors

- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days
prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during
the course of the study

- Known presence of the brain or spinal cord metastasis, as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or
prior radiographic assessments



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: Ipatasertib

Drug: Paclitaxel

Drug: Placebo

Primary Outcome(s)

PFS in Subjects with Phosphatase and Tensin Homolog (PTEN)-Low Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

Progression Free Survival (PFS) [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

Secondary Outcome(s)

Overall Survival (OS) [Time Frame: Baseline up to Clinical Cut Off Date (31 August 2019)]

Time to Disease Progression in Subjects with PTEN-Low Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

PFS in Subjects with Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib [Time Frame: Cycle 1 Day 1, Cycle 1 Day 8]

Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib [Time Frame: Cycle 1 Day 1, Cycle 1 Day 8]

Duration of Response [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

Mean Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score [Time Frame: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1]

Duration of Response in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30 [Time Frame: Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1]

Objective Response Rate (ORR) [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

ORR in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

ORR in Subjects with PTEN-Low Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

Time to Disease Progression [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

Time to Disease Progression in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

OS in Subjects with PIK3CA/AKT1/PTEN-altered Tumors [Time Frame: Baseline up to Clinical Cut Off Date (31 August 2019)]

Duration of Response in Subjects with PTEN-Low Tumors [Time Frame: Baseline up to Primary Completion Date (07 June 2016)]

OS in Participants with PTEN-Low Tumors [Time Frame: Baseline up to Clinical Cut Off Date (31 August 2019)]

Percentage of Participants with Adverse Events [Time Frame: Baseline up to approximately 2.5 years]

Secondary ID(s)

2014-000469-35

GO29227

Source(s) of Monetary Support

Please refer to primary and secondary sponsors