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: 17.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000568-28-ES
• Lead Sponsor: Roche Farma S.A en nombre de Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-22
• 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/?L
- Platelets count >=100,000/?L
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 for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment
- Patients for whom immediate surgery is indicated.
-Patients who have undergone sentinel lymph node biopsy prior to study treatment
-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.
- DLCO <60% of the predicted values (see Appendix 7 for calculations)

Study & Design

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