Trial Outcomes & Findings for STRIDE - STimulating Immune Response In aDvanced brEast Cancer (NCT NCT00925548)

Last Updated: 2014-07-24

Results Overview

PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

Results posted on

2014-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.	Placebo + Hormonal Therapy + NaCl 9 g/L Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Study STARTED	11	5
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.	Placebo + Hormonal Therapy + NaCl 9 g/L Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Overall Study Discontinuation of trial by sponsor	10	5

Baseline Characteristics

STRIDE - STimulating Immune Response In aDvanced brEast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide n=11 Participants Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.	Placebo + Hormonal Therapy + NaCl 9 g/L n=5 Participants Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.	Total n=16 Participants Total of all reporting groups
Age, Customized Less than (<) 65 years	5 participants n=99 Participants	2 participants n=107 Participants	7 participants n=206 Participants
Age, Customized Greater than or equal to (>=) 65 years	6 participants n=99 Participants	3 participants n=107 Participants	9 participants n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	5 Participants n=107 Participants	16 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

Population: Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).

PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Percentage of participants with objective tumor response was to be reported. An objective response (OR) was defined as a participant having a best overall response of either confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST 1.0) as assessed by independent radiological review.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Clinical Benefit is defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or stable disease (SD,) lasting for at least 22 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from randomization to PD, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from randomization to start of chemotherapy, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 9, 20, 32, 44 and end of trial visit

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

FACT-B questionnaire consists of 36 questions; 7 in physical well-being (PWB); 7 in social well-being (SWB); 6 in emotional well-being (EWB); 7 in functional well-being (FWB); 9 in breast cancer subscale (BCS). Trial outcome Index (TOI) was calculated by the sum of the physical well-being (PWB), functional well-being (FWB), and breast cancer scale (BCS) subscales of FACT-B. Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 9, 20, 32, 44 and end of trial visit

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were to be converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00. Higher scores on the EQ-5D represent a better quality of life (QoL) and lower scores on the EQ-5D represent a worst QoL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization up to end of trial visit

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

Healthcare Resource Utilization (HRU) parameters included direct medical resources (e.g., nonscheduled procedures, unplanned hospitalization, outpatient visits), nonmedical resources (e.g., travel, paid and unpaid assistance), and occupational resources (e.g., occupational changes and concerns).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 5, 9, 20, 32, 44 and end of trial visit

Population: Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)

CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.

Outcome measures

Outcome data not reported

Adverse Events

Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo + Hormonal Therapy + NaCl 9 g/L

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide n=11 participants at risk Single dose of cyclophosphamide (300 milligrams per square meter \[mg/m\^2\] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.	Placebo + Hormonal Therapy + NaCl 9 g/L n=5 participants at risk Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
Gastrointestinal disorders Intestinal obstruction	9.1% 1/11 • Baseline (First treatment dose) up to end of trial i.e. 27 Aug 2010 Adverse event (AE): Any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.	0.00% 0/5 • Baseline (First treatment dose) up to end of trial i.e. 27 Aug 2010 Adverse event (AE): Any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.

Other adverse events

Additional Information

Merck KGaA Communication Center

Merck Serono, a division of Merck KGaA

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER