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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02301988
• Date of registration: 24/11/2014
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
• Scientific 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
• Date of first enrolment: February 17, 2015
• Target sample size: 151
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02301988
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Portugal, Spain, United States

Contacts

• Name: Clinical Trials
• Affiliation: Genentech, Inc.

Key inclusion & exclusion 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



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

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Ipatasertib

Drug: Placebo

Drug: Paclitaxel

Primary Outcome(s)

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(s)

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 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 Adverse Events [Time Frame: Screening up to Week 24]

Plasma Concentrations of Ipatasertib on Day 1 and Day 8 [Time Frame: 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days)]

Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors [Time Frame: Surgery visit (at approximately Weeks 14 to 19)]

Minimum Observed Plasma Concentration (Cmin) of Ipatasertib [Time Frame: 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days)]

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 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 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 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 Response to Conversion to BCS Among Participants With T2 or T3 Tumors [Time Frame: From screening to surgery visit (at approximately Weeks 14 to 19)]

Secondary ID(s)

GO29505

2014-003029-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SOLTI Breast Cancer Research Group

Results

• Results available: Yes
• Date Posted: 20/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02301988