Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer (NCT NCT01363986)

Last Updated: 2014-08-11

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])

Results posted on

2014-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Trastuzumab Monotherapy Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Trastuzumab Monotherapy Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
Overall Study Disease progression	1

Baseline Characteristics

A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trastuzumab Monotherapy n=3 Participants Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
Age, Continuous	60 years n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])

Population: ITT population; 1 participant was not assessed at Cycle 7.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy n=2 Participants Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly 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	2 participants

SECONDARY outcome

Timeframe: Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)

Population: ITT population; 2 participants were not assessed 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.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy n=1 Participants Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15	0 participants

SECONDARY outcome

Timeframe: BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment

Population: ITT population; 1 participant was not assessed 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.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy n=2 Participants Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit	1 participant

SECONDARY outcome

Timeframe: 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

Population: ITT population; survival status of 1 participant was unknown at the final visit.

The number of participants surviving at the final visit.

Outcome measures

Outcome measures
Measure	Trastuzumab Monotherapy n=2 Participants Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
Overall Survival	1 participant

SECONDARY outcome

Timeframe: 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

Population: Due to the premature interruption of the study and the small number of enrolled participants (3 nerolled), all participant data were listed only, without any descriptive statistics or data analysis. The endpoint of B-PFS was thus not analyzed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Trastuzumab Monotherapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Trastuzumab Monotherapy n=3 participants at risk Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
Gastrointestinal disorders Nausea	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
General disorders Headache	66.7% 2/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
General disorders Asthenia	100.0% 3/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
General disorders Pyrexia	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
Nervous system disorders Epilepsy	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
Infections and infestations Device-related infection	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
Musculoskeletal and connective tissue disorders Gait disturbance	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.
General disorders Speech disorder	33.3% 1/3 • Adverse events were reported from randomization up through 28 days after the final study drug treatment. Safety was assessed in all consented participants who received study treatment.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER