Metastatic Breast Cancer MedDRA version: 14.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: trastuzumab-MCC-DM1 (TDM-1)
Product Code: RO5304020/F02
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: n/a
CAS Number: 1018448-65-1
Current Sp
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Completed T-DM1 treatment on the parent study or who continue to receive T-DM1 at the time of the parent study closure - Expectation by the investigator that the patient may continue to benefit from additional T-DM1 treatment - For women of childbearing potential, agreement to use an effective form of contraception (patient and/or partner, e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study treatment and for at least 6 months after the last dose of study treatment. For men, agreement to use an effective form of contraception and to continue its use for the duration of the study. 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 1 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Adverse events leading to T-DM1 discontinuation in the parent study - Ongoing serious adverse events from the parent study - Progressive disease during parent study or before starting the extension study - Peripheral neuropathy of Grade = 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 - History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, or history of myocardial infarction within 6 months prior to study entry - Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy - Current severe, uncontrolled systemic disease - Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment - Current pregnancy or lactation - History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (i.e., chemotherapy, Herceptin®) since the patient's last dose in the parent study - History of hypersensitivity with previous T-DM1 treatment, precluding further dosing - Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To provide continued T-DM1 therapy as single agent T-DM1 or in combination with paclitaxel or with pertuzumab ± paclitaxel to HER2-positive breast cancer patients who were previously enrolled in a Genentech/Roche-sponsored T-DM1 study and who derived benefit from the therapy administered in the parent study (patients must demonstrate no evidence of systemic disease progression and an acceptable safety profile at the completion of the parent study or at the time of the parent study closure.) • To collect safety data with regard to long-term administration of single agent T-DM1 or T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel.;Secondary Objective: not applicable - no secondary objectives;Primary end point(s): - Incidence of adverse events leading to T-DM1 discontinuation or dose reduction - Incidence of all adverse events and serious adverse events | — |
Countries
Austria, Germany, Hungary, Italy, Spain, United Kingdom
Contacts
Public ContactTrial Information Support Line TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed