An early-stage clinical trial to evaluate the safety and effectiveness of GDC-0032 when given alongside Tamoxifen to patients with HER2 negative advanced breast cancer, who have previously received hormone treatment

Phase 1

• Conditions: Hormone receptor positive metastatic breast cancer; MedDRA version: 20.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003947-51-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 322

Inclusion Criteria

Phase Ib (dose escalation)
- Minimum age for inclusion 18 years
•Breast cancer patients with ER and/or PR positive tumours, or patients with other cancer types whom the investigator considers might benefit from endocrine therapy combined with PI3K inhibition (for example ovarian cancer and cancer of the uterus).
•Patients with WHO performance status = 2
•Adequate organ and marrow function
•Fasting glucose = 120 mg/dL (=6.66 mmol/L) and HbA1c = ULN.
Randomized phase II:
•Pre- and Postmenopausal patients with histology-/cytology- proven ER and/or PR positive*, HER2 negative breast cancer, with recurrent or metastatic disease which has progressed on prior endocrine therapy. Premenopausal patients should also receive LHRH agonist
•Patient with WHO performance status = 2
•Adequate organ and marrow function
•Fasting glucose = 120 mg/dL (=6.66 mmol/L) and HbA1c = ULN.
•Patients must have either measurable or evaluable disease by RECIST criteria.
•Availability of a representative tumour tissue specimen

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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

Exclusion Criteria
• Patients with premenopausal follicle stimulating hormone (FSH) and/or plasma estradiol levels who are not treated with a LHRH agonist
• More than 5 prior chemotherapeutic regimens for metastatic breast cancer
•Endocrine therapies or small molecule targeted (non-cytotoxic) inhibitors (including investigational kinase inhibitors) within 5 half-lives of the compund or active metabolites with a maximum of 4 weeks.
•Cytotoxic chemotherapy within 3 weeks, or nitrosoureas or mitomycin C within 6 weeks before the first dose of the study treatment
•Antibody therapy within 4 weeks before the first dose of the study treatment
•Radiation therapy within 2 weeks before the first dose of study treatment
•Untreated, symptomatic, or progressive brain metastases.
•PT/ INR (PTT) test results at screening > 1.3 x the laboratory upper limit of normal.
•Corticosteroid use equivalent to more than 10mg prednisone daily
•Patients with a history of
- Thrombo-embolic disease, except if she is adequately treated with low molecular weight heparin, vit K antagonist or rivaroxbane. INR should be within target range
- Crohn’s disease or ulcerative colitis or other forms of autoimmune colitis
- Clinically significant cardiac or pulmonary dysfunction
- Type 1 or 2 diabetes requiring daily anti-hyperglycaemic medication

Study & Design

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