Trial Title:
Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer
NCT ID:
NCT00712140
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Conditions: Keywords:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
HER2-positive breast cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Primary purpose:
Treatment
Intervention:
Intervention type:
Biological
Intervention name:
trastuzumab
Description:
Given IV
Arm group label:
Arm I
Arm group label:
Arm II
Intervention type:
Drug
Intervention name:
parenteral chemotherapy
Description:
per the local institutional protocols either concurrently with or sequentially to trastuzumab
Arm group label:
Arm I
Arm group label:
Arm II
Summary:
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. It is not yet known which regimen
of trastuzumab is more effective in treating early breast cancer.
PURPOSE: This randomized phase III trial is comparing two trastuzumab regimens to see how
well they work in treating women with HER2-positive early breast cancer.
Detailed description:
OBJECTIVES:
Primary
- Determine disease-free survival of women with HER2-positive early breast cancer treated
with neoadjuvant or adjuvant trastuzumab (Herceptin®) for 6 months versus 12 months.
Secondary
- Determine the overall survival of patients treated with these regimens.
- Determine the expected incremental cost effectiveness (cost per quality adjusted life
year gained) for 6 months versus 12 months trastuzumab.
- Determine cardiac function as assessed by left ventricular ejection fraction every 3
months during treatment.
- Analyze the predictive factors for development of cardiac damage.
OUTLINE: This is a multicenter study. Patients are stratified according to estrogen receptor
status (negative vs positive); chemotherapy timing (adjuvant vs neoadjuvant); chemotherapy
type (anthracycline based [no taxane] vs taxane and anthracyclines vs taxane-based [no
anthracyclines]); and trastuzumab (Herceptin®) timing (concurrently vs sequentially [with
respect to chemotherapy]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks for up to 12 months in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks for up to 6 months in the absence of disease progression or unacceptable
toxicity.
All patients also receive standard chemotherapy regimens as per local institutional protocols
either concurrently with or sequentially to trastuzumab.
Patients complete quality of life questionnaires using the EuroQoL-5D (EQ-5D) at baseline and
periodically during study treatment. Patients also complete a diary on out-of-pocket expenses
associated with their condition (i.e., travel expenses, over-the-counter medicines and
supplements, complementary therapies not funded by NHS, home help, and time away from work)
for cost-effective analysis.
After completion of study therapy, patients are followed every 3 months for 1 year, then
every 6 months for 1 year, and annually thereafter.
Criteria for eligibility:
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- No evidence of metastatic disease
- Overexpression of HER2 receptor defined as 3+ or 2+ HER2 positivity measured by
fluorescent in situ hybridization (FISH) gene amplification
- Indication for chemotherapy based on the following clinical and histopathological
features:
- Receiving or scheduled to receive neoadjuvant chemotherapy
- Time between diagnosis biopsy and start date of chemotherapy should be less
than 1 month
- Receiving or scheduled to receive adjuvant chemotherapy
- Completely resected disease, with negative surgical margins (apart from deep
margin if full thickness resection)
- Marginally resected disease and/or positive sentinel nodes allowed provided
patients undergo completion of surgery (breast and/or axillary clearance)
after chemotherapy
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- Adequate bone marrow, hepatic, and renal function
- LVEF normal by ECHO or MUGA
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No clinically significant cardiac abnormalities
- No myocardial infarction within the past 6 months
- No uncontrolled or malignant hypertension
- No history of atrioventricular arrhythmia and/or congestive heart failure (even under
medical control), or active second or third degree cardiac block
- No history of allergy to drugs containing polysorbate 20 and the excipient polysorbate
80 (TWEEN 80®) or history of allergy to mouse proteins
- No co-morbidity significantly adding to risks associated with cytotoxic chemotherapy
(i.e., severe chronic obstructive pulmonary disease or poorly controlled diabetes)
- No prior diagnosis of malignancy unless managed by surgical treatment only and
disease-free for 10 years
- Prior basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in
situ of the breast allowed if treated by surgery only
- No concomitant medical or psychiatric problems that might preclude completion of
treatment or follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy
- Concurrent radiotherapy allowed
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Zip:
CB2 2QQ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Helena Earl, MBBS, PhD, FRCP
Phone:
44-1223-336-800
Facility:
Name:
Cumberland Infirmary
Address:
City:
Carlisle
Zip:
CA2 7HY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-1228-523-444
Facility:
Name:
Derbyshire Royal Infirmary
Address:
City:
Derby
Zip:
DE1 2QY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-1332-347-141 ext. 2407
Facility:
Name:
Eastbourne District General Hospital
Address:
City:
Eastbourne
Zip:
BN21 2UD
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-1323-417-400
Facility:
Name:
Luton and Dunstable Hospital
Address:
City:
Luton
Zip:
LU4 0DZ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-845-127-0127
Facility:
Name:
Clatterbridge Centre for Oncology
Address:
City:
Merseyside
Zip:
CH63 4JY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-151-334-1155
Facility:
Name:
James Cook University Hospital
Address:
City:
Middlesbrough
Zip:
TS4 3BW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-1642-850-850
Facility:
Name:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Address:
City:
Northwood
Zip:
HA6 2RN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-1923-826-111
Facility:
Name:
Peterborough Hospitals Trust
Address:
City:
Peterborough
Zip:
PE3 6DA
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-1733-874-510
Facility:
Name:
New Cross Hospital
Address:
City:
Wolverhampton
Zip:
WV10 0QP
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-190-230-7999
Facility:
Name:
Aberdeen Royal Infirmary
Address:
City:
Aberdeen
Zip:
AB25 2ZN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Contact Person
Phone:
44-84-5456-6000
Start date:
October 2007
Lead sponsor:
Agency:
Warwick Medical School
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on April 10, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00712140
