An Extension Study of trastuzumab emtansine administered as a single agent or in combination with other anti-cancer therapies in patients previously enrolled in a Genentech and /or F. Hoffmann-La Roche Ltd. - sponsored trastuzumab emtansine study.
- Conditions
- Metastatic CancerMedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: PTClassification code 10065430Term: HER2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: 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
- EUCTR2010-021067-32-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 234
- Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or treatment in the control arm of study BO21976/TDM4450g at the time of the study closure.
- Expectation by the investigator that the patient may continue to benefit from additional study treatment.
- For women of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner during the treatment period and for at least 5 months after the last dose of atezolizumab (if applicable) or 7 months after the last dose of trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period. For men, agreement to use an effective form of contraception and to continue its use for the duration of the study. Men must refrain from donating sperm during this same period.
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 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
- Adverse events leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment
discontinuation in the parent study.
- Ongoing serious adverse events from the parent study
- Progressive disease (except for isolated CNS progression) on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the 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 (V) 3.0 , V4.0 or V5.0,, as utilized in the parent study.
- 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, trastuzumab etc.) since the patient's last dose in the parent study.
- History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To provide trastuzumab emtansine therapy as single agent trastuzumab emtansine or in combination with other agents to HER2-positive metastatic cancer patients who derived benefit from therapy administered in the Genentech/Roche-sponsored trastuzumab emtansine parent study. <br>• To provide continued study treatment to patients in the control arm of study BO21976/TDM4450g who derived benefit from the treatment administered during the study.<br>• To collect safety data with regard to long-term administration of single agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other agents.;Secondary Objective: not applicable - no secondary objectives;Primary end point(s): - Incidence of adverse events leading to trastuzumab emtansine or combination treatment discontinuation or dose reduction.<br>- Incidence of all adverse events and all serious adverse events;Timepoint(s) of evaluation of this end point: Up to 3 years <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable