Solid Tumours (Future parent protocols may include other solid tumors that are not included in this section) MedDRA version: 20.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent - Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure - Investigator’s opinion that the patient continues to benefit from pertuzumab 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 213 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: - Meets any of the exclusion criteria of the Parent protocol at the time the patient is considered for entry in the extension study - Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study - Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study - Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion below. - More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study - Left ventricular ejection fraction = 50% - Any serious uncontrolled concomitant disease that would contraindicate the use of pertuzumab and/or any of the anti-cancer drug(s) given in combination with pertuzumab at the moment of the Parent study closure or that would put the patient at high risk for treatment-related complications. - Treatment with any anti-cancer treatment (other than any treatment given as permitted in the Parent protocol) in the time period between last treatment in the Parent study and the first dose pertuzumab in the extension study (i.e. up to 9 weeks) - Positive serum pregnancy test - Concurrent participation in any therapeutic clinical trial (other than the Parent study) - 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 pertuzumab therapy to patients who were previously enrolled in a F. Hoffmann-La Roche (Roche)-sponsored pertuzumab study (the Parent study) and who continue to derive benefit from pertuzumab-based therapy administered in the Parent study at the time of Parent study closure. ;Secondary Objective: To collect long-term safety and efficacy data of pertuzumab therapy.;Primary end point(s): Safety: Incidence of adverse events;Timepoint(s) of evaluation of this end point: After the last patient has completed their 7-month follow-up visit post-pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: Progression-free survival; overall survival;Timepoint(s) of evaluation of this end point: After the last patient has completed their 7-month follow-up visit post-pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first) | — |
Countries
Brazil, France, Germany, Italy, Korea, Republic of, Peru, Poland, Spain, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed