Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benefit

Phase 1

• Conditions: WOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCER; MedDRA version: 18.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000568-28-BE
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-06
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

• Histologically confirmed invasive breast carcinoma, with all of the following characteristics:
– Primary tumor = 2 cm in largest diameter (cT1-3) by MRI. In the case of a multifocal tumor (defined as the presence of two or more foci of cancer within the same breast quadrant), the largest lesion must be = 2 cm and designated as the target” lesion for all subsequent tumor evaluations.
– Stage I to operable Stage III breast cancer
– Documentation confirming the absence of distant metastasis (M0) as
determined by institutional practice (in patients where there may be a
reasonable suspicion of advanced disease e.g., large tumors, clinically positive axillary lymph nodes, signs and symptoms).
• ER-positive and HER2-negative breast cancer, as per local laboratory or regional definition
• Breast cancer eligible for primary surgery
• Tumor tissue from FFPE core biopsy of breast primary tumor that is confirmed as evaluable for PIK3CA mutation status by central histopathology laboratory
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Fasting glucose =125 mg/dL
• Adequate hematological, renal, and hepatic function, as follows:
– Absolute neutrophil count = 1500/µL
– Platelets count =100,000/µL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

•Any prior treatment for primary invasive breast cancer
•Patients with cT4 or cN3 stage breast tumors
•Metastatic (Stage IV) breast cancer
•Bilateral invasive breast cancer
•Multicentric breast cancer (the presence of more than one tumor in different quadrants of the breast)
•Patients who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes
•Patients who have undergone sentinel lymph node biopsy prior to study treatment
• Patients for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment
• Patients for whom immediate surgery is indicated
•Type 1 or 2 diabetes requiring antihyperglycemic medication
•Inability or unwillingness to swallow pills
•Malabsorption syndrome or other condition that would interfere with enteric absorption

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified