Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer

Locally Advanced HER2-negative Breast Cancer Clinical Trial

— TAME-01  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329627
• Other study ID #: NP 50/2010 - TAME
• Status: Terminated
• Phase: Phase 2
• First received: November 8, 2010
• Last updated: May 20, 2014
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: May 2014
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced HER2-negative Breast Cancer

Intervention

Drug:
• Paclitaxel/doxorubicin/cyclophosphamide
Metronomic chemotherapy as described below: Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.
• Paclitaxel/doxorubicin/cyclophosphamide
Metronomic chemotherapy as described below: Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.

Locations

Country	Name	City	State
Brazil	State of Sao Paulo Cancer Institute	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	Fundação Faculdade de Medicina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of febrile neutropenia	Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%	18 weeks	Yes
Secondary	Efficacy	Efficacy will be assessed by: Tumor measurements using MRI; Pathologic complete response; Progression-free survival; Overall survival	From the beginning of treatment until surgery, progression and death	No