This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
Schedule and dose at the investigator's discretion
Unnamed facility
Avellino, Italy
Unnamed facility
Brescia, Italy
Unnamed facility
Candiolo, Italy
Unnamed facility
Carrara, Italy
Unnamed facility
Cona (Ferrara), Italy
Unnamed facility
Cosenza, Italy
Unnamed facility
Crotone - Kr, Italy
Unnamed facility
Fano, Italy
Unnamed facility
Florence, Italy
Unnamed facility
Frattaminore, Italy
...and 25 more locations
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.
Time frame: Baseline (BL) and every 8 weeks thereafter
Progression-Free Survival - Time to Event
The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.
Time frame: BL and every 8 weeks thereafter
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.
Time frame: BL and every 8 weeks thereafter
Overall Survival - Time to Event
The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.
Time frame: BL and every 8 weeks thereafter
Percentage of Participants by Best Overall Response (BOR)
BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: BL and every 8 weeks thereafter
Percentage of Participants With a Best Overall Response of CR or PR
BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: BL and every 8 weeks thereafter
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