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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01329627

Acronym

TAME-01

Enrollment

Registered

2011-04-06

Start date

2010-08-31

Completion date

2012-08-31

Last updated

2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced HER2-negative Breast Cancer

Brief 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.

Interventions

DRUGPaclitaxel/doxorubicin/cyclophosphamide

Metronomic chemotherapy as described below: 1. Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; 2. Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of febrile neutropenia	18 weeks	Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%

Secondary

Measure	Time frame	Description
Efficacy	From the beginning of treatment until surgery, progression and death	Efficacy will be assessed by: 1. Tumor measurements using MRI 2. Pathologic complete response 3. Progression-free survival 4. Overall survival

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026