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Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients (RESPECT)

This study is currently recruiting participants.
Verified June 2011 by Comprehensive Support Project for Oncology Research
Sponsor:
Information provided by (Responsible Party):
Comprehensive Support Project for Oncology Research
ClinicalTrials.gov Identifier:
NCT01104935
First received: November 6, 2009
Last updated: April 17, 2012
Last verified: June 2011
History of Changes
  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
Drug: chemotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

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 7 years after initial enrollment (from Oct. 2009 through Oct. 2016). ] [ Designated as safety issue: No ]

    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 7 years after initial enrollment (from Oct. 2009 through Oct. 2016). ] [ Designated as safety issue: No ]
    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 7 years after initial enrollment (from Oct. 2009 through Oct. 2016). ] [ Designated as safety issue: No ]

    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, 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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 300
Study Start Date: October 2009
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: trastuzumab and chemotherapy Drug: trastuzumab
  • Trastuzumab: 1-year treatment
  • Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times "
Drug: 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 monotherapy Drug: trastuzumab
  • Trastuzumab: 1-year treatment
  • Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times "

  Eligibility

Ages Eligible for Study:   70 Years to 80 Years
Genders 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 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104935

Contacts
Contact: Masataka Sawaki +81 52-762-6111 m-sawaki@aichi-cc.jp
Contact: CSPOR Office +81352872633 support@csp.or.jp

Locations
Japan
Aichi Cancer Center Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Masataka Sawaki     +81 52-762-6111     m-sawaki@aichi-cc.jp    
Sponsors and Collaborators
Comprehensive Support Project for Oncology Research
Investigators
Principal Investigator: Masataka Sawaki Department of Breast Oncology, Aichi Cancer Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Comprehensive Support Project for Oncology Research
ClinicalTrials.gov Identifier: NCT01104935     History of Changes
Other Study ID Numbers: N-SAS BC 07, RESPECT
Study First Received: November 6, 2009
Last Updated: April 17, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013