We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104935
First Posted: April 16, 2010
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Comprehensive Support Project for Oncology Research
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: trastuzumab monotherapy Drug: trastuzumab and chemotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Comprehensive Support Project for Oncology Research:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017). ]

    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


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017). ]
    Overall survival is defined as the interval from the date of enrollment to the date of death from any cause.

  • Relapse-free survival [ Time Frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017). ]

    Relapse-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. Death

  • 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, 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. ]
    The following variables are evaluated: left ventricular ejection fraction, white-cell count, neutrophil count, platelet count, bilirubin level, alanine aminotransferase level, aspartate aminotransferase level, alkaline phosphatase level, and creatinine level.

  • 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. ]
    The following QOL questionnaire forms (in Japanese) are used for evaluations: FACT-G, HADS, EQ-5D, and PNQ.

  • 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. ]

    Survey items are as follows.

    1. Direct medical costs: medical costs associated with therapy, the management of adverse events, etc.
    2. Direct nonmedical costs: transportation expenses required for medical examinations, costs of health foods, etc.
    3. Indirect costs: work-loss costs associated with treatment that are incurred directly by the patient and by their caregivers


Enrollment: 275
Actual Study Start Date: October 28, 2009
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trastuzumab monotherapy

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
Other Name: Herceptin
Active Comparator: trastuzumab and chemotherapy

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
Other Name: Herceptin
Drug: trastuzumab and chemotherapy
Other Names:
  • PTX
  • DTX
  • TC
  • AC
  • EC
  • FEC
  • CMF
  • TCb (CBDCA)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years to 80 Years   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104935


Locations
Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
Sponsors and Collaborators
Comprehensive Support Project for Oncology Research
Investigators
Principal Investigator: Masataka Sawaki Department of Breast Oncology, Aichi Cancer Center Hospital
  More Information

Additional Information:
Responsible Party: Comprehensive Support Project for Oncology Research
ClinicalTrials.gov Identifier: NCT01104935     History of Changes
Other Study ID Numbers: N-SAS BC 07
First Submitted: November 6, 2009
First Posted: April 16, 2010
Last Update Posted: August 2, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents