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Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT00712140
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 9, 2008
Last Update Posted : September 2, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: parenteral chemotherapy Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Persephone: Duration of Trastuzumab With Chemotherapy in Women With Early Stage Breast Cancer: Six Months Versus Twelve
Study Start Date : October 2007
Estimated Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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. All patients also receive standard chemotherapy regimens as per local institutional protocols either concurrently with or sequentially to trastuzumab.
 Biological: trastuzumab
Given IV

Drug: parenteral chemotherapy
per the local institutional protocols either concurrently with or sequentially to trastuzumab
Experimental: 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.
 Biological: trastuzumab
Given IV

Drug: parenteral chemotherapy
per the local institutional protocols either concurrently with or sequentially to trastuzumab


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Cost effectiveness and quality of life
  3. Cardiac function and analysis of predictive factors for development of cardiac damage

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712140


Locations
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United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Helena Earl, MBBS, PhD, FRCP    44-1223-336-800      
Cumberland Infirmary Recruiting
Carlisle, England, United Kingdom, CA2 7HY
Contact: Contact Person    44-1228-523-444      
Derbyshire Royal Infirmary Recruiting
Derby, England, United Kingdom, DE1 2QY
Contact: Contact Person    44-1332-347-141 ext. 2407      
Eastbourne District General Hospital Recruiting
Eastbourne, England, United Kingdom, BN21 2UD
Contact: Contact Person    44-1323-417-400      
Luton and Dunstable Hospital Recruiting
Luton, England, United Kingdom, LU4 0DZ
Contact: Contact Person    44-845-127-0127      
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Contact Person    44-151-334-1155      
James Cook University Hospital Recruiting
Middlesbrough, England, United Kingdom, TS4 3BW
Contact: Contact Person    44-1642-850-850      
Mount Vernon Cancer Centre at Mount Vernon Hospital Recruiting
Northwood, England, United Kingdom, HA6 2RN
Contact: Contact Person    44-1923-826-111      
Peterborough Hospitals Trust Recruiting
Peterborough, England, United Kingdom, PE3 6DA
Contact: Contact Person    44-1733-874-510      
New Cross Hospital Recruiting
Wolverhampton, England, United Kingdom, WV10 0QP
Contact: Contact Person    44-190-230-7999      
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: Contact Person    44-84-5456-6000      
Sponsors and Collaborators
Warwick Medical School
Investigators
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Principal Investigator: Helena Earl, MBBS, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00712140    
Other Study ID Numbers: CDR0000598391
WMS-PERSEPHONE
MREC-PERSEPHONE
EUDRACT: 2006-007018-39
ISRCTN 52968807
MREC 07/MRE08/35
EU-20858
CRUK-BRD/07/137
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: November 2008
Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
HER2-positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents