Evaluation of Trastuzumab without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial

Phase 3

• Conditions: HER2 positive primary breast cancer in elderly

• Registration Number: JPRN-UMIN000002349
• Lead Sponsor: RESPECT executive committee

Brief Summary

Three-year DFS was 89.5% with trastuzumab monotherapy vs. 93.8% with trastuzumab + chemotherapy (HR, 1.36; 95% CI, 0.72 to 2.58; P = .51). At 3 years, restricted mean survival time differed by -0.39 months. The primary objective of noninferiority was not met. However, the observed loss of survival without chemotherapy was < 1 month at 3 years. In light of the lower toxicity and more favorable HRQoL profile, trastuzumab monotherapy can be considered an adjuvant therapy option for selected older patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-01
• Study Completion: 2017-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 275

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS), Relapse-free Survival (RFS), Safety, HRQOL, CGA, Cost Effectiveness Analysis