NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?

Breast Cancer Clinical Trial

— NeoSAMBA  

Official title:

Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01270373
• Other study ID #: Neo2010
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: June 2020

Study information

• Verified date: February 2020
• Source: Instituto Nacional de Cancer, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the usual and the reverse sequence of an anthracycline followed by a taxane in locally advanced breast cancer.

Description:

Anthracylines and taxanes are the most active chemotherapy agents in the treatment of breast cancer. The usual sequence of an anthracycline followed by a taxane is due to the timing of their discovery and introduction in the treatment armamentarium. More recent evidence suggests that there is pre clinical as well as clinical rational for the reverse sequence.

The neoadjuvant approach allows quick evaluation of these different treatment strategies. At the same time, the study will collect tissue biopsies and blood at different time points in order to evaluate predictive biomarkers.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: June 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Stage IIB to IIIB HER-2 negative breast cancer

2. ECOG performance status = 2

3. Neuropathy grade <1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0)

4. Adequate hematologic function with:

• Absolute neutrophil count (ANC) >1500/µL

• Platelets =100,000/µL

• Hemoglobin = 9 g/dL

5. Adequate hepatic and renal function with:

• Serum bilirubin = 1.5 x the institutional upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x institutional ULN

• Alkaline phosphatase =2.5 x institutional ULN

• Serum creatinine =1.5 x ULN or calculated creatinine clearance = 50 mL/min

6. Adequate cardiac function

• Left ventricular ejection fraction (LVEF) within institutional normal range

7. Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion criteria

1. Pregnancy

2. Bilateral, synchronous breast cancer

3. Previous diagnosis of breast or other cancer

4. Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that would make the patient inappropriate for this study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• FAC x 3 followed by Docetaxel x 3
5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles; followed by Docetaxel 100 mg/m2 every 21 days, for 3 cycles
• Docetaxel x 3 followed by FAC x 3
Docetaxel 100 mg/m2 IV every 21 days, for 3 cycles; followed by 5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles

Locations

Country	Name	City	State
Brazil	Hospital do Cancer III	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil	Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response		6 months
Secondary	Cardiac toxicity		5 months