Phase 3
Completed N=2,185
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
Source: ClinicalTrials.gov NCT01702571 ↗Enrolled (actual)
2,185
Serious AEs
21.2%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Participants With Adverse Events of Primary Interest (AEPIs) — 23.1; 51.4 Percentage of Participants
◆ Published Evidence
Highly cited
341citations · ~57 / year
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<sup>☆</sup>.
Summary
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.
Linked Publications (3)
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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<sup>☆</sup>.
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RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events of Primary Interest (AEPIs) |
23.1; 51.4 | — |
| SECONDARY Percentage of Participants With Specific AEPIs |
6.9; 12.2; 2.3; 1.1; 3.7; 36.5 | — |
| SECONDARY Percentage of Participants With Adverse Events of Special Interest (AESIs) |
1.2; 1.1; 0.2; 0.0 | — |
| SECONDARY Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment |
6.8; 5.7 | — |
| SECONDARY Overall Survival |
27.2; 29.5 | — |
| SECONDARY Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment |
29.3; 29.6 | — |
| SECONDARY Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1 |
47.1; 39.6 | — |
| SECONDARY Duration of Response (DOR) According to RECIST v 1.1 |
13.8; 14.2 | — |
| SECONDARY Time to Response According to RECIST v 1.1 |
22.3; 8.3 | — |
| SECONDARY Number of Hospital Visits |
2.7; 2.1 | — |
| SECONDARY Type of Hospital Visits |
558; 33; 39; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01702571) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.