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

NCT01104935 | Completed Phase 3 DMC

• 1 other identifier: N-SAS BC 07
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Disease-free survival is defined as the interval from the date of enrollment to the date of any of the following events. 1. Local recurrence, distant metastasis 2. Metachronous breast cancer, secondary cancer 3. Death

  Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).

Secondary Outcomes (5)

• Overall survival

  Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).

• Relapse-free survival

  Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).

• Percentage of participants with adverse events as a measure of safety

  Evaluations are performed at the time of starting the specified treatment and 2, 6, and 9 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)

  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

  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.

Study Arms (2)

trastuzumab monotherapy

EXPERIMENTAL

H group (trastuzumab monotherapy group) * Trastuzumab: 1-year treatment * Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times

Drug: trastuzumab monotherapy

trastuzumab and chemotherapy

ACTIVE COMPARATOR

H+CT group (combination therapy of trastuzumab and chemotherapy) * Chemotherapy: 12 to 24 weeks * Select chemotherapy from certain regimens (PTX, DTX, TC, AC, EC, FEC, CMF and TCb (CBDCA)) 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. In cases of TCb (CBDCA), trastuzumab is used concomitant administration.

Drug: trastuzumab monotherapy; Drug: trastuzumab and chemotherapy

Interventions

trastuzumab monotherapy DRUG

Also known as: Herceptin

trastuzumab and chemotherapy; trastuzumab monotherapy

trastuzumab and chemotherapy DRUG

Also known as: PTX, DTX, TC, AC, EC, FEC, CMF, TCb (CBDCA)

trastuzumab and chemotherapy

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
• Stage: 1 (tumor size \[pT\] \> 0.5 cm), 2A, 2B or 3A/ M0
• Female between 70 and 80 years old
• Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH
• Baseline left ventricular ejection fraction (LVEF) is ≥55% measured by echocardiography or MUGA scan within 4 weeks before registration.
• PS: 0-1 (ECOG)
• 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
• No previous endocrine therapy or chemotherapy for breast cancer

You may not qualify if:

• Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
• Postoperative histological axillary lymph node metastasis ≥4
• Axillary lymph node is not histologically evaluated
• Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
• History of drug-related allergy which could hinder planned treatment
• 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
• Poorly controlled hypertension (ex. Systolic arterial pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg)
• Poorly controlled diabetes
• Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (ADL)
• Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms
• Ineligible to the trial based on decision of an investigator

Sponsors & Collaborators

• Comprehensive Support Project for Oncology Research: lead

Study Sites (1)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Related Publications (4)

• Nozawa K, Sawaki M, Uemura Y, Tsuneizumi M, Takano T, Gondo N, Hara F, Harao M, Toyama T, Taira N, Vivancos A, Perou CM, Sanfeliu E, Braso-Maristany F, Parker JS, Buckingham W, Pare L, Villacampa G, Marin-Aguilera M, Villagrasa P, Prat A, Iwata H. HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab +/- chemotherapy. Nat Commun. 2025 Nov 4;16(1):9585. doi: 10.1038/s41467-025-65599-x.

  PMID: 41188218 DERIVED

• Hagiwara Y, Sawaki M, Uemura Y, Kawahara T, Shimozuma K, Ohashi Y, Takahashi M, Saito T, Baba S, Kobayashi K, Mukai H, Taira N. Impact of chemotherapy on cognitive functioning in older patients with HER2-positive breast cancer: a sub-study in the RESPECT trial. Breast Cancer Res Treat. 2021 Aug;188(3):675-683. doi: 10.1007/s10549-021-06253-0. Epub 2021 Jun 2.

  PMID: 34080094 DERIVED

• Taira N, Sawaki M, Uemura Y, Saito T, Baba S, Kobayashi K, Kawashima H, Tsuneizumi M, Sagawa N, Bando H, Takahashi M, Yamaguchi M, Takashima T, Nakayama T, Kashiwaba M, Mizuno T, Yamamoto Y, Iwata H, Ohashi Y, Mukai H, Kawahara T; RESPECT Study Group. Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer. J Clin Oncol. 2021 Aug 1;39(22):2452-2462. doi: 10.1200/JCO.20.02751. Epub 2021 Apr 9.

  PMID: 33835842 DERIVED

• Sawaki M, Taira N, Uemura Y, Saito T, Baba S, Kobayashi K, Kawashima H, Tsuneizumi M, Sagawa N, Bando H, Takahashi M, Yamaguchi M, Takashima T, Nakayama T, Kashiwaba M, Mizuno T, Yamamoto Y, Iwata H, Kawahara T, Ohashi Y, Mukai H; RESPECT study group. Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-Positive Early Breast Cancer in Older Patients. J Clin Oncol. 2020 Nov 10;38(32):3743-3752. doi: 10.1200/JCO.20.00184. Epub 2020 Sep 16.

  PMID: 32936713 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Drug Therapy; Carboplatin

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; Therapeutics; Coordination Complexes; Organic Chemicals

Study Officials

• Masataka Sawaki

  Department of Breast Oncology, Aichi Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: April 16, 2010
• Study Start: October 28, 2009
• Primary Completion: October 31, 2017
• Study Completion: October 15, 2018
• Last Updated: October 21, 2019

Record last verified: 2019-07

Locations

JP (1)