Clinical trial · Interventional
Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
A Phase 2 Study of Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
- 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)
In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
| Lapatinib | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Cohort 1
- description
- This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year. 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab
- interventionNames
- Drug: Lapatinib
- Drug: Herceptin
- type
- OTHER
- label
- Cohort 2
- description
- This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy 1000 mg daily Lapatinib 2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab
- interventionNames
- Drug: Lapatinib
- Drug: Herceptin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed invasive breast cancer, with stage IV disease * HER2-positive breast cancer, defined as 3+ staining by IHC or gene amplification by FISH * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension * Willingness to undergo a research biopsy of recurrent or metastatic disease * Prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry. * Completed radiation therapy at least 7 days prior to beginning protocol treatment * Cohort 1: No prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other HER2-directed therapy other than trastuzumab * Cohort 2: Up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other HER2-directed therapy except for trastuzumab * 18 years of age or older * Life expectancy of greater than 12 weeks * ECOG Performance Status 0-2 * Normal organ and marrow function as outlined in protocol * Cardiac ejection fraction, as assessed by either MUGA scan or echocardiogram greater than or equal to 50% * Able to take oral medications Exclusion Criteria: * Patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease * Active brain metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study * Clinically significant malabsorption syndrome * Uncontrolled intercurrent illness * Pregnant or breastfeeding women * Concurrent use of the medications listed in the protocol because of possible interaction with lapatinib
References
Publications (1)
- DERIVEDLin NU, Guo H, Yap JT, Mayer IA, Falkson CI, Hobday TJ, Dees EC, Richardson AL, Nanda R, Rimawi MF, Ryabin N, Najita JS, Barry WT, Arteaga CL, Wolff AC, Krop IE, Winer EP, Van den Abbeele AD. Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [18F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003). J Clin Oncol. 2015 Aug 20;33(24):2623-31. doi: 10.1200/JCO.2014.60.0353. Epub 2015 Jul 13. PMID 26169615