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


Phase 3
70 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Description:

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

Outcome Time Frame:

Patients are followed up for 7 years after initial enrollment (from Oct. 2009 through Oct. 2016).

Safety Issue:

No

Principal Investigator

Masataka Sawaki

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Breast Oncology, Aichi Cancer Center

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

N-SAS BC 07

NCT ID:

NCT01104935

Start Date:

October 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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