Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab, chemotherapy
Phase phase 3
Target HER2
Sponsor Comprehensive Support Project for Oncology Research
Start date October 2009
End date October 2017
Trial size 300 participants
Trial identifier NCT01104935, N-SAS BC 07, RESPECT

Summary

To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
trastuzumab
Trastuzumab: 1-year treatment Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times "
chemotherapy
Chemotherapy: 12 to 24 weeks Select chemotherapy from certain regimens (PTX, DTX, TC, AC, EC, FEC and CMF) based on decision of a physician or a patient. Initiate administration of trastuzumab after completion of chemotherapy as a sequential combination. However, concomitant administration is allowed when combining trastuzumab with PTX, DTX and CMF.
(Experimental)
trastuzumab
Trastuzumab: 1-year treatment Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times "

Primary Outcomes

Measure
Disease free survival
time frame: Patients are followed up for 7 years after initial enrollment (from Oct. 2009 through Oct. 2016).

Secondary Outcomes

Measure
Overall survival
time frame: Patients are followed up for 7 years after initial enrollment (from Oct. 2009 through Oct. 2016).
Relapse-free survival
time frame: Patients are followed up for 7 years after initial enrollment (from Oct. 2009 through Oct. 2016).
Percentage of participants with adverse events as a measure of safety
time frame: Evaluations are performed at the time of starting the specified treatment and 2, 3, and 6 month, 1 year, 1 year 6 months, 2 years, 2 years 6 months, and 3 years after the start of treatment. Subsequently, evaluations are done at 1-year intervals.
Health-related QOL (HRQOL)
time frame: Evaluations are performed at the time of starting the specified treatment and 2 months, 1 year, and 3 years after the start of treatment.
Cost effectiveness analysis
time frame: Data on direct medical costs for the 3-year period after the start of the treatment are obtained from CRF. Data on direct nonmedical costs and indirect costs are obtained from questionnaires 2, 12, and 36 months after starting the treatment.

Eligibility Criteria

Female participants from 70 years up to 80 years old.

Inclusion Criteria: 1. Histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer. 2. Stage: 1 (tumor size [pT] > 0.5 cm), 2A, 2B or 3A/ M0 3. Female between 69 and 81 years old 4. Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH 5. Baseline left ventricular ejection fraction (LVEF) is ≥55% measured by echocardiography or MUGA scan within 4 weeks before registration. 6. PS: 0-1 (ECOG) 7. Sufficient organ function meeting following criteria within 4 weeks before registration: - Leukocyte ≥2500 mm3 - Neutrophil ≥1500 mm3 - Platelet ≥100 000 mm3 - Serum total bilirubin ≤2.0 x upper limit of normal (ULN) - ALT (GPT) or AST (GOT) ≤2.5 x ULN - Serum creatinine ≤2.0 x ULN - ALP ≤2.5 x ULN 8. No previous endocrine therapy or chemotherapy for breast cancer 9. Signed written informed consent (Appendix A) Exclusion Criteria: 1. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs) 2. Postoperative histological axillary lymph node metastasis ≥4 3. Axillary lymph node is not histologically evaluated 4. Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site) 5. History of drug-related allergy which could hinder planned treatment 6. Any history or complication of following cardiac disorders - History of congestive heart failure, cardiac infarction - Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease 7. Poorly controlled hypertension (ex. Systolic arterial pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg) 8. Poorly controlled diabetes 9. Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (ADL) 10. Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms 11. Ineligible to the trial based on decision of an investigator

Additional Information

Official title Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial
Principal investigator Masataka Sawaki
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Comprehensive Support Project for Oncology Research.