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Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer


OBJECTIVES:

- To test if prophylactic cranial radiotherapy delivering 30 Gy in 10 fractions will
significantly reduce (from 35% to 21% at 2 years) the incidence of symptomatic brain
metastases in patients treated with trastuzumab (Herceptin®) for metastatic breast
cancer.

OUTLINE: This is a multicenter study. Patients are stratified by center, type of systemic
therapy (trastuzumab [Herceptin®] monotherapy vs combination with chemotherapy), hormone
receptor status, and presence of lung metastases (yes vs no). Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive taxane/trastuzumab therapy for 6 weeks. While continuing
taxane/trastuzumab therapy, patients then undergo 10 fractions of concurrent
prophylactic cranial radiotherapy in the absence of disease progression or unacceptable
toxicity.

- Arm II: Patients receive taxane/trastuzumab therapy without concurrent prophylactic
cranial radiotherapy.

All patients undergo quality of life assessments every 8 weeks for 9 months.

After completion of study treatment, patients are followed periodically for at least 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven breast carcinoma

- Metastatic or locally advanced disease

- Must demonstrate HER2 3+ positivity on IHC or 2+ over-expression and FISH test
demonstrating C-erB2 gene amplification

- No known or suspected brain metastases or CNS disease, as defined by the presence of
any of the following key symptoms:

- Headache

- Nausea and/or vomiting

- Clinical signs of raised intracranial pressure

- Seizures

- Focal symptoms

- Cognitive dysfunction

- Affective disorder

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Female

- Postmenopausal status not specified

- ECOG performance status 0 or 1

- Patients must a-priori be suitable for trastuzumab (Herceptin®) +/- chemotherapy in
terms of bone marrow, hepatic, and renal function

- No prior history of cerebrovascular disease or neurological disorder including
seizures

PRIOR CONCURRENT THERAPY:

- No prior cranial radiotherapy

- No prior neurosurgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Outcome Measure:

Incidence of symptomatic brain metastases

Safety Issue:

No

Principal Investigator

Peter A. Canney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Glasgow

Authority:

Unspecified

Study ID:

CDR0000588868

NCT ID:

NCT00639366

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

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