Know Cancer

or
forgot password

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


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

Thank you

Trial Information

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


Inclusion Criteria:



- Locally advanced breast cancer diagnosed by guided core biopsy

- T > 2 cm (any N), or any T and node positive (needle biopsy is required)

- Non-metastatic disease assessed by computed tomography and bone scintigraphy

- Histological grade 2 and Ki67 > 15% or

- Histological grade 3 or

- Any triple negative (TN) or

- Inflammatory breast cancer (IBC)

- Normal left ventricular ejection fraction (LVEF)

- HER2-negative disease

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 as cardiovascular diseases, chronic obstructive
pulmonary disease (COPD), renal or liver failure, psychiatric disorders

- LVEF value below institutional limits of normal

- Predominant lobular carcinoma histology

- Grade 1 tumors

- Detected or suspicious distant metastasis

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

- Male sex

- HER2-positive breast cancer

Type of Study:

Interventional

Study Design:

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 modified metronomic schedule (whithout GCSF) will be no higher than 10%

Outcome Time Frame:

18 weeks

Safety Issue:

Yes

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

TAME-01

NCT ID:

NCT01329627

Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Locally Advanced HER2-negative Breast Cancer
  • Breast Neoplasms

Name

Location