Conditions: Breast Cancer
Keywords: Phase III trial randomized cancer vaccine MUC1 BLP25 advanced breast cancer postmenopausal breast cancer immunotherapy of breast cancer Inoperable locally advanced, recurrent, or metastatic endocrine-sensitive Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).

Detailed description:
The purpose of the study is to determine whether the addition of the experimental mucinous glycoprotein 1 (MUC1) antigen-specific cancer immunotherapy tecemotide (L-BLP25) to hormonal treatment is effective in prolonging progression-free survival in postmenopausal women with endocrine-sensitive inoperable locally advanced, recurrent or metastatic breast cancer.

Arms:
arm 1: Investigational Arm:

* Pretreatment (Single Dose): 300 milligrams per square meter (mg/m\^2) up to a maximum dose of 600 mg of intravenous cyclophosphamide
* tecemotide (L-BLP25) plus Hormonal Therapy (Standard Dose) arm 2: Control Arm:

* Pretreatment (Single Dose): sodium chloride (NaCl) 9 grams per liter (g/L) infusion
* Placebo plus Hormonal Therapy (Standard Dose)

Interventions: intervention 1: Tecemotide (L-BLP25) and Hormonal Treatment intervention 2: Placebo of tecemotide (L-BLP25) and Hormonal Treatment intervention 3: cyclophosphamide intervention 4: sodium chloride (NaCl)
Intervention descriptions: intervention 1: Investigational Arm:

Pretreatment (Single Dose) 300 mg/m\^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg).

Primary treatment phase:

Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* (Week 1 to 8).

Maintenance treatment phase:

Hormonal treatment plus vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).

\*calculated as mass of lipopeptide (antigen) intervention 2: Control Arm:

Pretreatment (Single Dose) NaCl 9 g/L infusion as a substitute for cyclophosphamide.

Primary treatment phase:

Hormonal therapy plus 8 consecutive weekly subcutaneous placebo doses (Week 1 to 8).

Maintenance treatment phase:

Hormonal therapy plus placebo doses at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD). intervention 3: 300 mg/m\^2 (to a maximum of 600 mg) of intravenous cyclophosphamide. intervention 4: NaCl 9 g/L infusion

Protocol document: