Clinical trial · Interventional
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment
- 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 two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab Emtansine | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trastuzumab Emtansine (All Participants)
- description
- This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
- interventionNames
- Drug: Trastuzumab Emtansine
- type
- EXPERIMENTAL
- label
- Trastuzumab Emtansine (Asian Participants)
- description
- This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
- interventionNames
- Drug: Trastuzumab Emtansine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HER2-positive disease determined locally * Histologically or cytologically confirmed invasive breast cancer * Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent * Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy * Measurable and/or non-measurable disease * Left ventricular ejection fraction (LVEF) \>/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 * Adequate organ function * Use of highly effective contraception as defined by the protocol Exclusion Criteria: * History of treatment with trastuzumab emtansine * Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not * Peripheral neuropathy of Grade \>/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0 * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer * History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria * History of exposure to cumulative doses of anthracyclines * History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade \</=1) prior to first study treatment. * Metastatic central nervous system (CNS) disease only * Brain metastases which are symptomatic * History of a decrease in LVEF to less than (\<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment * History of symptomatic CHF (New York Heart Association \[NYHA\] Classes II-IV) or serious cardiac arrhythmia requiring treatment * History of myocardial infarction or unstable angina within 6 months of first study treatment * Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy * Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease) * Pregnancy or lactation * Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus * History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product
References
Publications (3)
- DERIVEDWuerstlein R, Ellis P, Montemurro F, Anton Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Pena-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7. PMID 36084395
- DERIVEDEngebraaten O, Yau C, Berg K, Borgen E, Garred O, Berstad MEB, Fremstedal ASV, DeMichele A, Veer LV', Esserman L, Weyergang A. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nat Commun. 2021 Nov 5;12(1):6427. doi: 10.1038/s41467-021-26018-z. PMID 34741021
- DERIVEDMontemurro F, Delaloge S, Barrios CH, Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Pena-Murillo C, Yilmaz M, Donica M, Ellis P. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆. Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020. Epub 2020 Jul 5. PMID 32634611