A Phase 2 interventional study of trastuzumab [Herceptin] in Breast Cancer, sponsored by Hoffmann-La Roche. Terminated at 16 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-11.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on study treatment is 18 weeks.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 3 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.), followed by weekly doses of 2 mg/kg i.v. for up to 18 weeks.
Drug: trastuzumab [Herceptin]
Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks.
Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7
Brain objective response was defined as either a complete response (CR) or partial response (PR), provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all central nervous system (CNS) lesions. PR was defined as a greater than or equal to (≥) 30 percent (%) reduction in the volumetric sum of all measurable CNS lesions.
Time frame: Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])
Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15
Brain objective response was defined as either a CR or PR, provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
Time frame: Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)
Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit
Brain objective response was defined as either a CR or PR), provided that there was no increase in steroid requirements, or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
Time frame: BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment
Overall Survival
The number of participants surviving at the final visit.
Time frame: Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment
Brain Progression-Free Survival (B-PFS)
B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.
Time frame: Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment
| Milestone | Trastuzumab Monotherapy |
|---|---|
| Started | 3 |
| Completed | 2 |
| Not completed | 1 |
| Withdrew: Disease progression | 1 |
Brain objective response was defined as either a complete response (CR) or partial response (PR), provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all central nervous system (CNS) lesions. PR was defined as a greater than or equal to (≥) 30 percent (%) reduction in the volumetric sum of all measurable CNS lesions.
| participants | Trastuzumab Monotherapy |
|---|---|
| Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7 | 2 |
Brain objective response was defined as either a CR or PR, provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
| participants | Trastuzumab Monotherapy |
|---|---|
| Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15 | 0 |
Brain objective response was defined as either a CR or PR), provided that there was no increase in steroid requirements, or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.
| participant | Trastuzumab Monotherapy |
|---|---|
| Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit | 1 |
The number of participants surviving at the final visit.
| participant | Trastuzumab Monotherapy |
|---|---|
| Overall Survival | 1 |
B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.
No measurements were reported for this outcome.
Collected over Adverse events were reported from randomization up through 28 days after the final study drug treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trastuzumab Monotherapy | — | 0/3 (0%) | 3/3 (100%) |
| Event | Trastuzumab Monotherapy |
|---|---|
| AstheniaGeneral disorders | 3/3 |
| HeadacheGeneral disorders | 2/3 |
| NauseaGastrointestinal disorders | 1/3 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/3 |
| PyrexiaGeneral disorders | 1/3 |
| EpilepsyNervous system disorders | 1/3 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/3 |
| Device-related infectionInfections and infestations | 1/3 |
| DiarrhoeaGastrointestinal disorders | 1/3 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/3 |
Intent to treat (ITT) population included all consented participants who received study treatment.
| Age, Continuous(years) | Trastuzumab Monotherapy |
|---|---|
| Median | 60 (37 to 74) |
| Sex: Female, Male(Participants) | Trastuzumab Monotherapy |
|---|---|
| Female | 3 |
| Male | 0 |
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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