A study in patients with HER2-positive breast cancer that has spread and has not responded to one course of anti-cancer therapy.
- Conditions
- HER2 positive metastatic breast cancerMedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001628-37-GR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2003
1. HER2-positive disease determined locally i.e., IHC 3 + and/or gene-amplified by ISH as per institutional practice, (however, both tests should be performed wherever possible and only one positive result is required for eligibility)
2. Histologically or cytologically confirmed invasive BC
3. Prior treatment for BC in the advanced/metastatic, unresectable locally advanced or metastatic setting must include an anti-HER2 agent and chemotherapy in combination or sequential administration (complementary hormonal therapy is allowed)
4. Documented progression of incurable, unresectable, locally advanced, or mBC, 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 non-measurable disease
6. Signed written informed consent approved by the institution’s independent Ethical Committee (EC)
7. Age = 18 years
8. Left ventricular ejection fraction = 50% by either ECHO or MUGA
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
10. Adequate organ function
11. For women of childbearing potential and men with partners of childbearing potential agreement by the patient and/or partner to use a highly effective non-hormonal form of contraception.
12. Negative serum pregnancy test for women of childbearing potential and for all women not meeting the definition of postmenopausal, and who have not undergone surgical
sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential.
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 860
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
1. History of treatment with trastuzumab emtansine
2. Prior enrolment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not
3. 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, or cancers with a similar curative outcome as those mentioned above
4. 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
5. History of exposure to the following cumulative doses of anthracyclines:
• Doxorubicin or liposomal doxorubicin > 500 mg/m2
• Epirubicin > 900 mg/m2
• Mitoxantrone >120 mg/m2
• If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin.
6. History of radiation therapy within 14 days of first study treatment. The patient must have recovered from any resulting acute toxicity (to Grade = 1) prior to first study treatment.
7. CNS only disease
8. Brain metastases which are symptomatic. NOTE: A 14 days window after end of radiotherapy must be observed. Patient must not be receiving steroids to control symptoms.
9. History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment
10. History of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
11. History of myocardial infarction or unstable angina within 6 months of first study treatment
12. Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
13. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
14. Pregnancy or lactation
15. Currently known active infection with HIV, hepatitis B virus, or hepatitis C virus
16. History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins
17. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol throughout
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