NCT01104935

National Surgical Adjuvant Study of Breast Cancer(N-SAS BC) 07 [RESPECT]

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Comprehensive Support Project for Oncology Research · Academic / Other
• Sex: Female
• Age: 70 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, comparative trial of postoperative adjuvant therapies in women with HER2 (human epidermal growth factor receptor type-2)-positive primary breast cancer who are ≥70 years of age that will compare trastuzumab (Herceptin®) monotherapy (H group) and trastuzumab in combination with chemotherapy (H+CT group). The objectives of this study are as follows. 1. To verify the clinical positioning of trastuzumab monotherapy and combined trastuzumab and chemotherapy as postoperative adjuvant therapies for the treatment of HER2-positive primary breast cancer patients who are ≥70 years of age. 2. To evaluate the safety of trastuzumab monotherapy and combined trastuzumab and chemotherapy in patients who are ≥70 years of age. In particular, to evaluate cardiac disorders that are a characteristic adverse drug reaction of trastuzumab as well as geriatric-related concerns including lipid metabolism, cerebral infarction and cognitive disorders. 3. To evaluate overall survival in patients who are ≥70 years of age using trastuzumab monotherapy or combined trastuzumab and chemotherapy. 4. To evaluate health-related quality of life (HRQOL), cost-effectiveness (utility), and conduct a comprehensive geriatric assessment (CGA) in patients who are ≥70 years of age and using trastuzumab monotherapy or combined trastuzumab and chemotherapy. 5. To establish and expand information networks by the participation of practitioners in clinical trials that are involved in general clinical practice and breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	trastuzumab monotherapy
DRUG	trastuzumab and chemotherapy

Timeline

• Start date: 2009-10-28
• Primary completion: 2017-10-31
• Completion: 2018-10-15
• First posted: 2010-04-16
• Last updated: 2019-10-21

Locations

1 site across 1 country: Japan