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Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Locally Advanced HER2-positive Breast Cancer

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Trial Information

Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer


Inclusion Criteria:



- Diagnosis of locally advanced breast cancer

- T > 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size
is less than 2cm)

- Non-metastatic disease confirmed by computerized tomography and bone scan

- HER2 positive by IHC (+++) and/or Fish (+) according to international definitions
(ASCO 2007)

- Normal left ventricular ejection fraction (LVEF)

- Indication of preoperative chemotherapy

- multifocal tumors acceptable provided that the largest tumor is Her2-positive

- ECOG 0-1

Exclusion Criteria:

- Another malignancy within the last 5 years (except curatively treated skin carcinoma,
in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular
carcinoma of the breast)

- Clinically significant comorbidities such as cardiovascular diseases, COPD, renal or
liver impairment, psychiatric disorders

- LVEF value below institutional limits of normal range

- Detected or suspected distant metastasis

- Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower
than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin
higher than ULN, alkaline phosphatase more than 1.5x ULN

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

INCIDENCE OF FEBRILE NEUTROPENIA

Outcome Description:

INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%

Outcome Time Frame:

18 weeks

Safety Issue:

Yes

Authority:

Brazil: National Comittee of Ethics in Research

Study ID:

TraQ-Me 01

NCT ID:

NCT01329640

Start Date:

September 2010

Completion Date:

September 2012

Related Keywords:

  • Locally Advanced HER2-positive Breast Cancer
  • Metronimic chemotherapy
  • Locally Advanced HER2-positive Breast Cancer
  • Breast Neoplasms

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