Phase 2 N=151 Randomized Double-blind Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02301988 ↗

Enrolled (actual)

151

Serious AEs

8.6%

Results posted

Sep 2018

Primary outcome: Primary: 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) — 17.1; 13.3 percentage of participants — p=0.519

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ipatasertib (Drug); Paclitaxel (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Genentech, Inc.
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	17.1; 13.3	0.519
PRIMARY 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)	15.8; 12.5	0.7817
SECONDARY Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants)	22.4; 14.7	0.2234
SECONDARY 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)	15.8; 18.8	0.8169
SECONDARY 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)	67.1; 56.0	0.1607
SECONDARY Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors)	73.7; 50.0	0.1486
SECONDARY 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+])	17.9; 11.8	0.4980
SECONDARY 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+)	21.4; 11.8	0.3032
SECONDARY Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype	18.5; 21.9; 22.0; 10.8; 33.3; 0	—
SECONDARY Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors	64.5; 60.3	0.6280
SECONDARY Percentage of Participants With Response to Conversion to BCS Among Participants With T2 or T3 Tumors	33.3; 25	0.6291
SECONDARY Percentage of Participants With Adverse Events	100; 98.7	—
SECONDARY Plasma Concentrations of Ipatasertib on Day 1 and Day 8	290; 196; 37.5; 355	—
SECONDARY Minimum Observed Plasma Concentration (Cmin) of Ipatasertib	37.5	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02301988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.