ELIGIBILITY FORM (for the 1st 3 courses)

Evidence Building Program Eligibility Form
Adjuvant Trastuzumab with Chemotherapy for HER2/neu-Overexpressing Breast Cancer
Tumours Less than or Equal to 1 cm in Diameter
1.
Patient Profile
Surname:
________________________________
Given
Name:
__________________________________
OHIN:
________________________________
Chart
Number:
__________________________________
Postal Code:
________________________________
Height
(cm):
__________
Weight
(kg):
____________
Date of Birth:
_____ •______•_______
2
BSA (m ):
________________
Gender
(M, F or O):
Day
____________
Month
Year
Facility:
________________________________
Physician:
Physician’s
Fax #:
________________________________
Physician’s
Email:
__________________________________
2.
__________________________________
Eligibility Criteria
a. For breast cancer patients with node negative HER2-positive tumours ≥ 1mm and ≤ 1cm;
 HER2-positive defined as either IHC3+ or FISH/SISH ratio of ≥ 2
b. The patient is a candidate for trastuzumab-based chemotherapy;
 If age ≤ 50 years, LVEF ≥ 50% based on MUGA or ECHO
 If age > 50 years, LVEF ≥ 55% based on MUGA or ECHO
 No clinically significant cardiac disease
 Adequate marrow, renal and hepatic function
c.
3.
Trastuzumab will be used in combination with, or sequentially after, adjuvant chemotherapy
Baseline Information
a. Date of pathological diagnosis:
_____ •______•_______
Day
1
Month
Year
b. Tumour size _________cm
unreported
c.
1
2
3
d. Histology
Ductal
Lobular
Other
e. Multifocality
Yes
No
f.
ER status
If positive, ER _____%
Positive
Negative
g. PR status
If positive, PR _____%
Positive
Negative
Tumour grade
h. Lymphovascular invasion
Yes
No
i.
IHC3+
FISH/SISH ≥ 2
Test(s) to confirm HER2 positivity:
unreported
j.
LVEF baseline ________%
k.
Cardiac Testing Method
l.
Adjuvant endocrine therapy (please select all that apply):
Tamoxifen
Aromatase Inhibitor
Other: ________________
Not applicable
MUGA
ECHO
m. Adjuvant chemotherapy:
CEF
AC
CMF
FEC-T
FEC
AC-Docetaxel
dd-AC-Taxol
AC-Taxol
weekly paclitaxel
Other(please specify):__________________
TC (see note)
AC-Taxol-weekly
n. Patient has undergone
Breast Conservation Surgery
Mastectomy
Not Applicable
o. Adjuvant radiotherapy (please select one)
Local
Regional
Local & Regional
Not applicable
p. Has the patient received prior trastuzumab treatments?
Yes
No
Number of prior trastuzumab treatments (equivalent of q3 weeks): _________
q. Date of first trastuzumab treatment
_____ •______•_______
Day
5.
Month
Year
Notes
a. Prior approval by CCO is required. The completed eligibility form along with a copy of the baseline pathology report (with the
date of the biopsy, staging and other information [e.g. tumour size, tumour grade, node status, histology, hormone receptor
status, HER2 status, HER2 testing information, multifocalilty, etc.), and the left ventricular ejection fraction (LVEF) results
(MUGA or echocardiography [ECHO]) can be uploaded through CCO’s secure link https://ebp.cancercare.on.ca.
b. LVEF results using MUGA or ECHO must be completed before the start of trastuzumab (and after an anthracycline-based
chemotherapy), every three months while on trastuzumab and then at twelve months after completion of trastuzumab. Should
cardiac symptoms or greater than 10% absolute asymptomatic decline in LVEF occur within twelve months after completion of
trastuzumab, then annual cardiac assessments following trastuzumab completion may be considered.
c. Cardiac function tests demonstrating normal LVEF must be provided to CCO every three months from the start of trastuzumab
therapy to ensure continued reimbursement. Should the patient experience cardiac symptoms requiring discontinuation of
trastuzumab, a cardiologic assessment documenting the ability to continue therapy must also be provided to CCO when
treatment is resumed. The documents can be uploaded using CCO’s secure link https://ebp.cancercare.on.ca
d. Trastuzumab dosing is q3 weeks (loading dose 8mg/kg IV x1, followed by 6mg/kg q3 weeks). The total treatment duration is
one year (or the equivalent of eighteen q3 week treatments) or until limited by cardiotoxicity. Trastuzumab may be
administered once weekly (or q2 weeks) for eight weeks (during the paclitaxel component), then q3 weeks for patients receiving
the dose-dense AC-Taxol regimen (weekly dosing would involve a loading dose of 4mg/kg IV x1, followed by 2mg/kg IV weekly;
the dose for q2 weeks is the same as the q3 week dosing).
e. Trastuzumab may be used with any chemotherapy that is considered standard of care for breast cancer tumours >1cm. If the
drug used in the regimen of choice is currently funded by the NDFP, the corresponding NDFP eligibility form would also need to
be submitted to CCO (NDFP funding policies will apply). If TC is the regimen of choice, then completion of this form will
automatically enroll the patient for the docetaxel component of the TC, which will also be funded as part of the Evidence
Building Program.
f.
If trastuzumab is discontinued for more than five weeks, prior approval must be obtained before resuming treatment (as per the
HERA trial).
The patient named above, or relevant substitute decision-maker where applicable, has been informed of the process for submission
of the patient’s reimbursement claim to the EBP program and has provided their consent for the collection, use and disclosure of the
patient’s personal health information, as detailed in the Evidence Building Program eligibility form, by Cancer Care Ontario for the
purposes of administering the EBP program.
________________________________________
Signature of Prescribing Physician
Trastuzumab – Breast – 81.2
2
_____ •______•_______
Day
Month
Year