Clinical trial · Interventional
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
A Phase Ib, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Activity of Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0941 | Drug | Pictilisib | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| trastuzumab-MCC-DM1 | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0941
- Drug: trastuzumab-MCC-DM1
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: GDC-0941
- Drug: trastuzumab-MCC-DM1
- type
- EXPERIMENTAL
- label
- C
- interventionNames
- Drug: GDC-0941
- Drug: Trastuzumab
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented locally advanced or metastatic breast cancer that has progressed on at least one trastuzumab-based regimen in the metastatic or locally advanced setting * HER2-positive disease documented by one of the following results using FDA-approved testing methods: FISH-positive, chromogenic in situ hybridization (CISH)-positive, or IHC 3 + by local laboratory assessment * Life expectancy \>= 90 days * Agreement to use an effective form of contraception for the duration of the study Exclusion Criteria: * History of Grade \>= 3 hypersensitivity reaction to trastuzumab, or Grade \>= 1 with the most recent trastuzumab infusion before study entry, or continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions * History of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued * Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to Day 1 * Prior investigational anti-cancer therapy within 4 weeks prior to Day 1 * Grade \>= 2 peripheral neuropathy * History of Grade \>= 3 hyperglycemia (fasting) * History of Type 1 or Type 2 diabetes requiring daily medication * History of clinically significant cardiac or pulmonary dysfunction * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus * Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytic agents * Any condition requiring \> 2 grams of acetaminophen daily * Need for current chronic corticosteroid therapy * Pregnancy, lactation, or breast-feeding * Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) * Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of the need for major surgery during the course of study treatment * Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy * Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
References
Publications (0)
Data not yet available