A Study of Trastuzumab-MCC-DM1 (T-DM1) in Combination With Docetaxel in Patients With Advanced Breast Cancer.
- Conditions
- Treatment in patients with advanced, HER2-positive breast cancerMedDRA version: 14.1 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-010000-28-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 98
1. Signed written informed consent.
2. Age = 18 years.
3. ECOG PS of 0 or 1.
4. Life expectancy of = 12 weeks.
5. Histologically or cytologically confirmed breast cancer, which is documented to be metastatic or inoperable, locally advanced without meeting the LABC criteria, and amenable for treatment with docetaxel.
6. Evaluable (Feasibility Part only) or measurable (Extension Part) disease (as defined by RECIST 1.0).
7. HER2-positive disease locally confirmed by HER2 protein over expression.
8. History of progression within 3 months prior to study entry.
for LABC Patients
9. Histologically or cytologically confirmed newly diagnosed locally advanced breast cancer defined as stage IIIa to stage IIIC disease according to the American Joint Committee on Cancer (AJCC) staging system [62]:
• T2 to T4d tumor
• Any N
• M0
10. HER2-positive breast cancer as defined by IHC 3+ and/or FISH positive, prospectively confirmed by a Sponsor designated central laboratory prior to enrollment
11. Locally advanced breast cancer amenable for treatment with neoadjuvant docetaxel based chemotherapy
12. Patient agreement to undergo mastectomy or lumpectomy after neoadjuvant treatment
Amenable to investigational therapy with the combination of T-DM1 and docetaxel prior to the initiation of standard of care.
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 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Pregnant or lactating females.
2. Women of childbearing potential unless surgically sterile or using adequate measures of contraception (intra-uterine device or barrier method of contraception in conjunction with spermicidal jelly).
3. Patients must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of the pain in progressing metastatic bone lesions (limited to < 30% of marrow bearing bone) and/or brain metastasis. Patients must have recovered from their radiotherapy-related toxicities.
4. Significant cardiac disease including but not confined to:
- Inadequate left ventricular ejection function (LVEF) at baseline, as defined as LVEF =50% by either echocardiogram or MUGA.
- New York Health Association (NYHA) Class =I congestive heart failure.
- Current unstable angina or serious cardiac arrhythmia despite adequate medication.
- Myocardial infarction or clinically significant valvular heart disease within the last 6 months prior to enrollment in the study.
- History of exposure to high doses of anthracyclines.
5. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability, which could affect ability to give informed consent, or compliance with study drugs.
6. Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment. CT or MRI scan of the brain is mandatory within 28 days of first treatment.
7. Treatment with any investigational drug within 30 days prior to commencing treatment with study drug.
8. Inadequate organ function of the a) Liver b) Kidney c) Bone marrow d) Peripheral nervous system:Peripheral neuropathy of =Grade 2 per NCI CTC for AE Version 3.0.
9. Patients with serious, uncontrolled, intercurrent illness including infections (bacterial or viral) and poorly controlled diabetes mellitus.
10. Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen.
11. Incomplete wound healing following major surgical procedure, open biopsy or significant traumatic injury or anticipation of the need for major surgery during the course of the study treatment.
10. Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications.
11. Known hypersensitivity to any of the study drugs, trastuzumab, murine proteins or excipients.
12. Inability to comply with the protocol.
13. Patients unable or unwilling to participate in the study.
for MBC Patients:
14. Patients must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of the pain in progressing
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