An Open-Label Study of Trastuzumab Emtansine (T-DM1) vs Capecitabine+Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer (EMILIA).
- Conditions
- Treatment of patients with HER2-positive unresectable, locally advanced or metastatic breast cancer with progressive disease who have previously received a taxane and trastuzumab, at the minimum, in any breast cancer disease setting.MedDRA version: 17.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-005713-22-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 991
a. Disease-Specific Criteria
1. Prospective centrally confirmed HER2-positive MBC.
2. Histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or MBC.
3. Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: A taxane, alone or in combination with another agent and Trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced or metastatic setting.
4. Documented progression of incurable unresectable, locally advanced, or metastatic breast cancer, defined by the investigator: Progression must occur during or after most recent treatment for locally advanced/MBC or within 6 months after completing adjuvant therapy.
5. Measurable and/or nonmeasurable disease. Patients with CNS-only disease are excluded.
b. General Criteria
6. Age = 18 years
7. Cardiac ejection fraction = 50% by either ECHO or MUGA
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. Adequate organ function.
• For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception. Contraception use should continue for the duration of the study treatment and for at least 7 months after the last dose of study treatment.
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 853
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 138
a. Cancer-Related Criteria
1. History of treatment with trastuzumab emtansine
2. Prior treatment with lapatinib or capecitabine.
3. Peripheral neuropathy of Grade = 3 per NCI CTCAE
4. History of other malignancy within the last 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, or cancers with a similar curative outcome as those mentioned above.
5. History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which can be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria
6. History of radiation therapy within 14 days of randomization, The patient must have recovered from any resulting acute toxicity (to Grade = 1) prior to randomization.
7. Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) before randomization
b. Cardiopulmonary Function
8. History of symptomatic CHF or serious cardiac ventricular arrhythmia requiring treatment
9. History of myocardial infarction or unstable angina within 6 months of randomization
10. Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
c. General Criteria
11. Current severe, uncontrolled systemic disease
12. Pregnancy or lactation
13. Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
14. Presence of conditions that could affect gastrointestinal absorption
15. History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab
16. Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency
17. Current treatment with sorivudine or its chemically related analogs, such as brivudine.
18. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (i.e., unable to swallow pills).
19. Have discontinued from the TDM4370g/BO21977 study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method