Clinical trial NCT01363986: A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
Official title: A Multicenter, Open Label Study to Assess the Effect of Trastuzumab + Whole Brain Radiotherapy (WBRT) on Brain Metastases From HER-2 Positive Breast Cancer. (bHERt-2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of breast carcinoma with HER-2 overexpression
* At least one measurable brain metastasis
* Patients for whom, according to investigator assessment, whole brain radiotherapy is the best therapeutic option
* Performance status (WHO) \</=2
* Life expectancy \>/=3 months

Exclusion Criteria:

* Presence of neoplastic meningitis
* Any prior radiotherapy to the brain
* Patients for whom, according to investigator assessment, stereotactic radiotherapy is the best therapeutic option
* Previous neoplasms, other than breast carcinoma, within 5 years since enrolment

Primary outcomes:
measure: Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7
timeFrame: Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])
Secondary outcomes:
measure: Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15
timeFrame: Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)
measure: Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit
timeFrame: BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment
measure: Overall Survival
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
measure: Brain Progression-Free Survival (B-PFS)
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
Other outcomes:
Locations:
city: Ancona
country: Italy
city: Brindisi
country: Italy
city: Candiolo
country: Italy
city: Firenze
country: Italy
city: Latina
country: Italy
city: Lecce
country: Italy
city: Meldola
country: Italy
city: Parma
country: Italy
city: Ravenna
country: Italy
city: Roma
country: Italy
city: Rozzano
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Saronno
country: Italy
city: Sassari
country: Italy
city: Torino
country: Italy
city: Viterbo
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: