Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer

NCT00712140 | Unknown Phase 3

• 8 other identifiers: CDR0000598391WMS-PERSEPHONEMREC-PERSEPHONEEUDRACT: 2006-007018-39ISRCTN 52968807MREC 07/MRE08/35EU-20858CRUK-BRD/07/137
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 11

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.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; HER2-positive breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (3)

• Overall survival

• Cost effectiveness and quality of life

• Cardiac function and analysis of predictive factors for development of cardiac damage

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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; Drug: parenteral chemotherapy

Arm II

EXPERIMENTAL

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; Drug: parenteral chemotherapy

Interventions

trastuzumab BIOLOGICAL

Given IV

Arm I; Arm II

parenteral chemotherapy DRUG

per the local institutional protocols either concurrently with or sequentially to trastuzumab

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Warwick Medical School: lead

Study Sites (11)

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

RECRUITING

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

RECRUITING

Eastbourne District General Hospital

Eastbourne, England, BN21 2UD, United Kingdom

RECRUITING

Luton and Dunstable Hospital

Luton, England, LU4 0DZ, United Kingdom

RECRUITING

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

RECRUITING

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

RECRUITING

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

RECRUITING

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

RECRUITING

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

RECRUITING

Related Publications (2)

• Earl H, Hiller L, Vallier AL, Loi S, McAdam K, Hughes-Davies L, Rea D, Howe D, Raynes K, Higgins HB, Wilcox M, Plummer C, Mahler-Araujo B, Provenzano E, Chhabra A, Gasson S, Balmer C, Abraham JE, Caldas C, Hall P, Shinkins B, McCabe C, Hulme C, Miles D, Wardley AM, Cameron DA, Dunn JA. Six versus 12 months' adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT. Health Technol Assess. 2020 Aug;24(40):1-190. doi: 10.3310/hta24400.

  PMID: 32880572 DERIVED

• Earl HM, Hiller L, Vallier AL, Loi S, McAdam K, Hughes-Davies L, Harnett AN, Ah-See ML, Simcock R, Rea D, Raj S, Woodings P, Harries M, Howe D, Raynes K, Higgins HB, Wilcox M, Plummer C, Mansi J, Gounaris I, Mahler-Araujo B, Provenzano E, Chhabra A, Abraham JE, Caldas C, Hall PS, McCabe C, Hulme C, Miles D, Wardley AM, Cameron DA, Dunn JA; PERSEPHONE Steering Committee and Trial Investigators. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial. Lancet. 2019 Jun 29;393(10191):2599-2612. doi: 10.1016/S0140-6736(19)30650-6. Epub 2019 Jun 6.

  PMID: 31178152 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Helena Earl, MBBS, PhD, FRCP

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 9, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2011
• Last Updated: September 2, 2011

Record last verified: 2008-11

Locations

GB (11)